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| | | #REDIRECT [[User:Shawndouglas/Sandbox]] |
| {{ombox
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| | type = notice
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| | style = width: 960px;
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| | text = This is my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
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| }}
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| | |
| ==Sandbox begins below==
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| | |
| :1.1 '''Evaluation demonstration requirements'''
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| ::a. The solution must be available for full demonstration (preferably online), and the provider must be able to conduct an on-site demonstration. Explain your ability to meet these conditions.
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| :1.2 '''IT requirements'''
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| ::1.2.1 IT General
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| :::a. Single database that supports multiple laboratory sites and laboratory departments
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| | |
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| {|
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| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| |-
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| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.1 '''Vendor requirements'''
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
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| |-
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| | style="padding:5px; width:500px;" |'''a.''' Vendor offers full demonstration (preferably online) and can conduct an on-site demonstration
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''b.''' Vendor provides optional comprehensive set of test codes suitable for use by the purchasing facility
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''c.''' Vendor provides a support schedule for the implementation process, including optional levels
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''d.''' Vendor can detail the amount of time and staff that purchaser will have to provide for the implementation process
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''e.''' Vendor can explain function and availability of additional support capabilities
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''f.''' Vendor has a consistent training methodology for training new users
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''g.''' Vendor provides support during the "go-live" period between system validation/operational deployment and final acceptance/beginning of maintenance and support agreements
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''h.''' Vendor provides design qualification documentation
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''i.''' Vendor provides installation qualification documentation
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''j.''' Vendor provides operation qualification documentation
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''k.''' Vendor provides performance qualification documentation during implementation
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''l.''' Vendor provides user, administrator, developer, installation, and reference manuals
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''m.''' Vendor provides a gap analysis after initial system installation, identifying the deliverables or tasks remaining
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''n.''' Vendor provides description of maintenance and support offered during and after implementation, including times and methods of availability, issue escalation and management, etc.
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''o.''' Vendor provides a detailed project approach and project plan that includes the project team, timeline, deliverables, and risk and issue management procedures
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''p.''' Vendor provides a table linking each deliverable to the corresponding user requirement specification it fulfills
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''q.''' Vendor provides a reliable cost estimates and pricing schedules, including all products and services included in the scope of work
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''r.''' Vendor supplies LIMS-specific training program curricula
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''s.''' Vendor supplies information about their overall project approach, acknowledgement of the deliverables, time/schedule constraints, and any other criteria for the project
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| |}
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| |-
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| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.2 '''IT requirements'''
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| |-
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| ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.2.1 '''IT general'''
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
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| |-
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| | style="padding:5px; width:500px;" |'''a.''' Single database that supports multiple laboratory sites and laboratory departments
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''b.''' Client passwords encrypted in database with support for multi-case and special characters
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''c.''' Secured Socket Layer (SSL) encryption on web client interface
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''d.''' System designed so upgrades to back-end database do not require extensive reconfiguration or effectively cripple the system
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''e.''' System provides all secured users access to its data via the Internet, LAN, or direct modem connection
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''f.''' LIMS database conforms to [[ODBC|Open Database Connectivity Standard]] (ODBC)
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''g.''' All LIMS system files capable of having security applied to them
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''h.''' All servers and workstations accessing LIMS system have login security
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''i.''' LIMS able to use TCP/IP as its network transport
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''j.''' Sized to not be impacted by multiple users or failover processes
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''k.''' Archive utility without off-line
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''l.''' System provides a workstation and server authentication mechanism
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''m.''' System provides local restore capability without support intervention
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''n.''' System Interfaces with database using ASP/ASP.net
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''o.''' System able to maintain transactional history
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.2.2 '''Hardware environment'''
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
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| |-
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| | style="padding:5px; width:500px;" |'''a.''' System compatible with the hardware environment
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.2.3 '''Software environment'''
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
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| |-
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| | style="padding:5px; width:500px;" |'''a.''' System utilizes a non-proprietary database such as Oracle or Microsoft SQL Server
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''b.''' System compatible with the software environment
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
| |
| |-
| |
| |}
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| |-
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| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.3 '''Regulatory compliance requirements'''
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
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| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' LIMS has security consistent with [[21 CFR Part 11]] and [[40 CFR Part 3]]; system has security to enter the system, settable automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and full electronic signature; provides a single point of access for all programs associated with the system for ease of administration and use
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''b.''' [[Audit trail]] and specifications violation trails maintained; audit trail includes result changes, header information changes, as well as the user, date/time, and a required reason for the changes as a standard part of the application
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''c.''' System maintains an audit trail of all data manipulation, consistent with all applicable regulations and standards
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''d.''' System provides user selectable [[The NELAC Institute|NELAP]]-compliant internal [[chain of custody]] that tracks all samples and associated containers from the time they are collected until disposed of
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''e.''' System meets all standards of [[The NELAC Institute]]
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''f.''' System provides persistent auditing capabilities
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''g.''' System meets government requirements for handling classified information and documents
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''h.''' System includes automatic date and time stamping
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''i.''' System provides the ability to insert/manage secure electronic and/or digital signatures
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''j.''' System supports [[ISO/IEC 17025]]
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''k.''' System supports [[21 CFR Part 11]]
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''l.''' System supports [[40 CFR Part 3]]
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''m.''' System supports [[HIPAA]] requirements
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''n.''' System supports [[GALP]] and/or [[GAMP]] standards
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
| |
| |}
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| |-
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| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.4 '''General functional requirements'''
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| |-
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| ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.4.1 '''General'''
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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
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| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
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| |-
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| | style="padding:5px; width:500px;" |'''a.''' System tracks status and workflow of the accession throughout the laboratory lifecycle, from submission to final analysis, including receiving, diagnostic testing, diagnostic test result reporting, and billing
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''b.''' System supports barcoded specimen labeling and tracking
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''c.''' System supports multiple customer payment sources (e.g. grants}
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''d.''' System can track current status of diagnostic tests in an accession
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''e.''' System contains spell-check dictionary that allows authorized users to add, edit, or remove entries
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''f.''' LIMS includes system administration ability to reset user passwords
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''g.''' LIMS can interface with or import existing data
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''h.''' LIMS can be configured to meet the characteristics of the laboratory
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''i.''' System capable of storing multiple sample-related objects such as pictures, documents, PDF files, etc., including any instrument-generated format outputs from equipment
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''j.''' System capable of storing sample comments, special information fields which are project- or sample-specific, user defined fields, data objects like scanned chain of custodies and digital photos of such items as sample events, bitmaps, movies, .wav audio files, and Word documents
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''k.''' User able to store object files such as pictures from microscopes, GCMS scans of peaks, or even raw data files from instrument runs for later processing
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''l.''' LIMS provides non-LIMS trained personnel access to the LIMS data via a simple Windows-type browser interface which permits the display of data from sample points, projects, or user-defined queries
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''m.''' System provides for application-based security by limiting external users to functions they are password-privileged to perform
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| | style="padding:5px; width:500px;" |'''n.''' System provides sample tracking from login through final reporting and invoicing
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''o.''' System produces internal chain of custody data to track individual sample containers and test results
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''p.''' System eliminates (or significantly reduces) redundant data entry and paper trail
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''q.''' System manages archived, paper-based laboratory records
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''r.''' System has a screen print function
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''s.''' System has an analyst communication log
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''t.''' System has configurable role-based security
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''u.''' System utilizes role-based presentation of menus and functions
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''v.''' System has supervisor override of chain of custody
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''w.''' System provides automatic logout based on keyboard or mouse inactivity
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| | style="background-color:white; padding:5px;" |
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| | style="background-color:white;" |
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| |-
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| | style="padding:5px; width:500px;" |'''x.''' System prompts users for a reason for changes to database record
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''y.''' System allows authorized personnel to review audit logs
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''z.''' System's numbering scheme allows for sub-numbering while maintaining parent-child relationships
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''aa.''' Chain of custody is printable for items, cases, projects, and batches
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ab.''' System has inter-lab transfer function
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ac.''' System allows queries of legacy data
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ad.''' Audit log retains all data, prohibits any deletions, and allows user comments
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ae.''' System search engine permits multiple search criteria
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''af.''' System permits remote access for users, system admins, and support agents
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ag.''' System supports the definition and maintenance of edit tables and lists
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ah.''' System allows modification of records by system admins, with audit trail
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ai.''' System allows entry, maintenance, and administration of customers, suppliers, and other outside entities
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''aj.''' System links or embeds standard operation procedure (SOP) access
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ak.''' System provides single data entry, automatically populates other data fields, and remembers pertinent and relevant data so it doesn't need to be re-entered, selected, or searched for
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''al.''' System provides an intuitive, user-friendly graphical user interface (GUI), consistent with Microsoft products
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''am.''' System captures data from all laboratory processes, ensuring uniformity of statistical reporting and other electronic data shared with designated users of the data
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''an.''' System provides data archival and retention functionality
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ao.''' System efficiently utilizes standardized data input points and enhanced individual workload tracking
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ap.''' System provides full database keyword and field search capability
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''aq.''' System provides read-only access to contract laboratory results
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ar.''' System allows use of navigation keys to freely move from field to field
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''as.''' System allows data tables to be sorted
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''at.''' System issues sequential numbers for chain of custody
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''au.''' System allows multiple users to connect simultaneously to contract lab
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''av.''' System notifies users of events like the scheduling, receipt, and completion of tasks
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''aw.''' System includes the ability to set up alerts via email
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ax.''' System includes the ability to search multiple databases
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ay.''' System supports multiple users entering data simultaneously
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''az.''' Data migrated into system converts cleanly to allow for reporting of historical sample collection
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.2 '''Configuration and customization'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' User can independently add fields without requiring reconfiguration of the system after routine upgrades and maintenance
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''b.''' System supports customized screens with user-definable information specific to an analysis
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''c.''' System allows addition of universal fields on all samples logged into the system at any time during or after implementation, while neither voiding the warranty nor requiring vendor review at a later date
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' System can expand to accommodate a new discipline
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' System can integrate additional printers and scanners
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' System allows the system admin to create custom screens, apps, and reports
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' System dynamically changes captions (labels) on system fields
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' System has dynamically configurable limit periods and notification hierarchy
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' System can be easily and efficiently modified to meet lab growth and changing business needs
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.3 '''Receiving and scheduling'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' System creates and maintains an electronic accession record for each accession received
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''b.''' Electronic accession records support digital picture and document uploads in standard formats
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''c.''' System allows users to handle billable and non-billable tests on the same accession
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' System supports tracking of shipping and receiving
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' System can receive accession/analysis request information from web-enabled forms
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' System can process automated uploading of field-derived sample collection data
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' System supports a user-configurable, spreadsheet-style, templated multi-sample login without requiring additional programming
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' Multi-sample login supports the modification of sample or sample batch information prior to actual login
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' Multi-sample login supports ad-hoc samples not predefined in the sample point list
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''j.''' System can print user-definable chain of custodies, worksheets, routing sheets, and custom labels upon login
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''k.''' System creates, saves, and recalls pre-login groups for routine samples to simplify recurring logins
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''l.''' System includes comprehensive sample scheduling, tracking, and sample flow management
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''m.''' System provides a comprehensive view of all samples and projects in the system using a color-coded status view of the current and scheduled samples via user configurable templates without requiring additional programming
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''n.''' System schedules routine samples on an hourly, daily, weekly, or monthly basis, allowing them to be enabled and disabled as a group
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' System streamlines login of recurring sampling projects
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' System supports automatic assignment of analysis requests
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''q.''' System can generate a monthly sampling schedule from a schedule database
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''q.''' System can generate labels for recurring samples and sample groups
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.4 '''Analysis and data entry'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' System provides auto-commenting for common laboratory result comments
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''b.''' System provides normal data range values for diagnostic tests
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''c.''' System includes default input values for diagnostic tests
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' System stores non-narrative textual results in searchable fields
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' System's user interface displays visual indicator such as status icons to indicate a sample's status in the workflow
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' System allows incorrectly inputted data to be corrected
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' System able to fully manage all aspects of laboratory quality control as well as report and chart all quality control data captured in the lab
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' System supports a variety of test protocols, each capable of storing test comments, test required, and special information like GCMS conditions or special objects associated with the test
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' System provides for a single test code requiring multiple analytes as targets
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''j.''' System supports and qualifies text-based tests
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''j.''' System supports single-component tests such as pH, BOD, CD, etc.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''k.''' System allows user to specify a single-component, multi-component, or narrative text test or group of tests, which represent all tests required
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''l.''' System allows QA/QC test to be easily created and associated with the primary analytical test
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''m.''' System provides colored visual indication of previously entered data as well as new data associated with a single sample When a result is entered, with the indicator changing color if the value is out of specification
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''n.''' System allows file transfer of data from instrument or user-generated files, with full on-screen review prior to database commitment
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' System reads results from previously entered tests to calculate a final result and immediately displays the calculated result
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' System permits result entry via intelligent instrument interfaces or multi-sample/multi-test ASCII files
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''q.''' System provides high-volume multi-component transfer of results with ability to automatically match samples to data files in either a backlog mode or a designated file mode, to parse the data, and to review and commit the sample data.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''r.''' System checks data files for specification and corrects them for specific reporting and analyte limits and qualifiers like dilution factor, automatically assigning qualifiers based on project analyte limiting
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''s.''' System allows on-screen review of the stored result, diluted result with corrected MDLs, and qualifiers after running samples for multiple dilutions such as GCMS
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''t.''' System stores test-related analysis comments with the test
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''u.''' System displays the standard operating procedure (SOP) associated with each test result to ensure proper techniques are used
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''v.''' System limits LIMS test code authorization to only qualified personnel and maintains their certification(s) to run assigned tests
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''w.''' System uses a menu-driven process for results validation
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''x.''' System's results validation process can access all information about a sample or group of samples, including comments or special information about the sample
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''y.''' System allows authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''z.''' System validation screens check each result against its individual sample location specifications (both warning and specification limits)
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''aa.''' System supports validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ab.''' System permits user-generated and modifiable Excel calculations on all tests
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ac.''' System automatically flags out-of-range quality control limits
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ad.''' System provides an overview of all outstanding analyses for better coordination of work schedules
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ae.''' System permits manual data entry into an electronic worksheet of test measurements and results
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''af.''' System electronically transfers an item during testing from one functional area to another
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ag.''' System provides secure electronic peer review
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ah.''' System provides a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc.
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ai.''' System allows automated or semi-automated data insertion
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''aj.''' System updates sample/item status when tests are completed
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ak.''' System calculates monthly QA/QC percentages for testing
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''al.''' System distinguishes between QA/QC duplicates and normal samples
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''am.''' System distinguishes between routine and duplicate analysis
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''an.''' System tracks changes in data structure and content
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ao.''' System allows user-friendly changes of data
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ap.''' System can validate/approve data prior to being moved to the main database
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.5 '''Instruments'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' System bilaterally interfaces with instruments and related software
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''b.''' System provides a database of preventative maintenance, calibration, and repair records for laboratory equipment, preferably supported by standardized reporting
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''c.''' System downloads data directly from laboratory instruments
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' System Schedules calibration/verification tasks in the worksheets or work flow process
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' System permits the defining and exporting of sequences to instruments
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.6 '''External system interfaces'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' System can direct output from ad-hoc queries to a computer file for subsequent analysis by other software
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''b.''' System can exchange data with National Identification System (NAIS) tracking systems
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''c.''' System provides a library of common and/or basic electronic data deliverable (EDD) formats
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' System can transfer data to and from another record management system
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' System supports dockable mobile devices
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' System can import data from and export data to Microsoft Word, Excel, and/or Access
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' System integrates with Microsoft Exchange services
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' System can interface with contract laboratories to electronically retrieve datasheets, sample analysis, and other related information
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' System can interface with non-Microsoft programs
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.7 '''Reporting'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' System clearly differentiates released preliminary data from fully validated results
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''b.''' System electronically transmits results via final report only when all case reviews have been completed by the case coordinator
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''c.''' System can automatically post periodic static summary reports on an internal web server
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' System provides ad-hoc web reporting interface to report on user-selected criteria
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' System can transmit results in a variety of ways including fax, e-mail, print, and website in formats like RTF, PDF, HTML, XML, DOC, XLS, and TXT
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' System supports multiple web browsers when viewing online reports
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' System capable of creating QA/QC charts for all recovery, precision, and lab control samples via a full statistics package
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' System includes several standard reports and query routines to access all samples with the pending status through a backlog report that includes the following criteria: all laboratory, department, analysis, submittal date, collection date, prep test complete, location, project, sample delivery group, and other user-selectable options
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' System produces a read-only progress report that allows printed reports of sample status and data collected to date
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''j.''' System automatically creates and transmits a separate exception report for all stored out-of-specification data
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''k.''' System displays history of previous results for an analyte's sample point in a tabular report, graphic trend chart, and statistical summary
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''l.''' System creates and transmits exception trails and reporting for all entered out-of-specification results
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''m.''' System permits sample progress reports to be viewed locally or remotely based on security application limits and/or sample ownership
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''n.''' System prevents a sample from being placed in a report queue until approved
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' System includes a versatile report writer and forms generator
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' System includes a custom graphic generator for forms
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''q.''' System allows development of specific templates for different types of reports
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''r.''' System can produce management and turn-around time reports and graphs
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''s.''' System can produce customized final reports
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''t.''' System can create and automatically update control charts
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''u.''' System generates, stores, reproduces, and displays laboratory reports on demand, including narrative
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''v.''' System generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand, including narrative
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''w.''' System can send on-screen output to printer or file
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''x.''' System allow users to query and print chain of custody
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''y.''' System supports report queries by fields/keys, status, completion, or other variables
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''z.''' System prohibits issuing reports outside of qualified areas
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''aa.''' System can generate reports from any data in tables
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ab.''' System uses Microsoft Office tools for formatting reports
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ac.''' System can automatically produce laboratory reports of findings and other written documents
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ad.''' System can automatically produce individual and aggregate workload and productivity reports on all operational and administrative activities
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ae.''' System can generate template letters for semi-annual reports
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''af.''' System permits database access using user-friendly report writing and inquiry tools
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''ag.''' System maintains template versions and renditions, allowing management and tracking of the template over time
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.4.8 '''Laboratory management'''
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Functional requirement
| |
| ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Notes
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''a.''' System allows search of invoice information by invoice number, account number, accession, payment types, client, or requested diagnostic test(s)
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''b.''' System allows system administration ability to configure multiple levels of user rights by site location, department, or job functions
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''c.''' System allows management of documents like SOPs, MSDS, etc. to better ensure they are current and traceable
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''d.''' System provides email notification of lockout, security access, and improper workstation access
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''e.''' System includes a performance assessment tracking method
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''f.''' System allows users to monitor reagent use and chemical expirations
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''g.''' System monitors proficiency test assignment, completion, and casework qualification for analytical staff
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''h.''' System allows authorized persons to assign work to analysts
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''i.''' System allows authorized persons to review pending work by analyst prior to assigning additional work
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''j.''' System allows authorized persons to review unassigned work by discipline and lab
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''k.''' System permits the management of information workflow, including notifications for requests and exigencies
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''l.''' System allows authorized persons to select and assign tasks by analysts, work group, instrument, test, sample, and priority
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''m.''' System permits records management and monitors resources by analyst, priority, analysis, and instrument
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''n.''' System provides analysis tools for laboratory operations to better support resource planning, productivity projections, workload distribution, and work scheduling
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''o.''' System calculates administrative and lab cost
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' System tracks number of visits per specific industry
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| | style="padding:5px; width:500px;" |'''p.''' System allows creation, modification, and duplication of user profiles
| |
| | style="background-color:white; padding:5px;" |
| |
| | style="background-color:white;" |
| |
| |-
| |
| |}
| |
| |}
| |
