Difference between revisions of "User:Shawndouglas/sandbox"

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#REDIRECT [[User:Shawndouglas/Sandbox]]
{{ombox
| type      = notice
| style    = width: 960px;
| 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>
}}
 
==Sandbox begins below==
 
:1.1 '''Evaluation demonstration requirements'''
::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.
:1.2 '''IT requirements'''
::1.2.1 IT General
:::a. Single database that supports multiple laboratory sites and laboratory departments
 
 
{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.1 '''Vendor requirements'''
|-
  ! 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.''' Vendor offers full demonstration (preferably online) and can conduct an on-site demonstration
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Vendor provides optional comprehensive set of test codes suitable for use by the purchasing facility
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Vendor provides a support schedule for the implementation process, including optional levels
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Vendor can explain function and availability of additional support capabilities
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' Vendor has a consistent training methodology for training new users
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' Vendor provides design qualification documentation
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' Vendor provides installation qualification documentation
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' Vendor provides operation qualification documentation
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' Vendor provides performance qualification documentation during implementation
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''l.''' Vendor provides user, administrator, developer, installation, and reference manuals
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''m.''' Vendor provides a gap analysis after initial system installation, identifying the deliverables or tasks remaining
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''p.''' Vendor provides a table linking each deliverable to the corresponding user requirement specification it fulfills
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''r.''' Vendor supplies LIMS-specific training program curricula
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.2 '''IT requirements'''
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.2.1 '''IT general'''
|-
  ! 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.''' Single database that supports multiple laboratory sites and laboratory departments
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Client passwords encrypted in database with support for multi-case and special characters
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Secured Socket Layer (SSL) encryption on web client interface
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' System designed so upgrades to back-end database do not require extensive reconfiguration or effectively cripple the system
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' System provides all secured users access to its data via the Internet, LAN, or direct modem connection
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' LIMS database conforms to [[ODBC|Open Database Connectivity Standard]] (ODBC)
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' All LIMS system files capable of having security applied to them
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' All servers and workstations accessing LIMS system have login security
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' LIMS able to use TCP/IP as its network transport
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' Sized to not be impacted by multiple users or failover processes
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' Archive utility without off-line
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''l.''' System provides a workstation and server authentication mechanism
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''m.''' System provides local restore capability without support intervention
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' System Interfaces with database using ASP/ASP.net
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''o.''' System able to maintain transactional history
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.2.2 '''Hardware environment'''
|-
  ! 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 compatible with the hardware environment
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.2.3 '''Software environment'''
|-
  ! 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 utilizes a non-proprietary database such as Oracle or Microsoft SQL Server
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' System compatible with the software environment
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.3 '''Regulatory compliance requirements'''
|-
  ! 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.''' 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' System maintains an audit trail of all data manipulation, consistent with all applicable regulations and standards
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' System meets all standards of [[The NELAC Institute]]
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' System provides persistent auditing capabilities
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' System meets government requirements for handling classified information and documents
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' System includes automatic date and time stamping
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' System provides the ability to insert/manage secure electronic and/or digital signatures
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' System supports [[ISO/IEC 17025]]
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' System supports [[21 CFR Part 11]]
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''l.''' System supports [[40 CFR Part 3]]
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''m.''' System supports [[HIPAA]] requirements
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' System supports [[GALP]] and/or [[GAMP]] standards
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.4 '''General functional requirements'''
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.4.1 '''General'''
|-
  ! 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 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' System supports barcoded specimen labeling and tracking
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' System supports multiple customer payment sources (e.g. grants}
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' System can track current status of diagnostic tests in an accession
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' System contains spell-check dictionary that allows authorized users to add, edit, or remove entries
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' LIMS includes system administration ability to reset user passwords
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' LIMS can interface with or import existing data
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' LIMS can be configured to meet the characteristics of the laboratory
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''m.''' System provides for application-based security by limiting external users to functions they are password-privileged to perform
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' System provides sample tracking from login through final reporting and invoicing
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''o.''' System produces internal chain of custody data to track individual sample containers and test results
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''p.''' System eliminates (or significantly reduces) redundant data entry and paper trail
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''q.''' System manages archived, paper-based laboratory records
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''r.''' System has a screen print function
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''s.''' System has an analyst communication log
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''t.''' System has configurable role-based security
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''u.''' System utilizes role-based presentation of menus and functions
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''v.''' System has supervisor override of chain of custody
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''w.''' System provides automatic logout based on keyboard or mouse inactivity
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | 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
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  | style="padding:5px; width:500px;" |'''q.''' System allows development of specific templates for different types of reports
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  | style="padding:5px; width:500px;" |'''r.''' System can produce management and turn-around time reports and graphs
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  | style="padding:5px; width:500px;" |'''s.''' System can produce customized final reports
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  | style="padding:5px; width:500px;" |'''t.''' System can create and automatically update control charts
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  | style="padding:5px; width:500px;" |'''u.''' System generates, stores, reproduces, and displays laboratory reports on demand, including narrative
  | style="background-color:white; padding:5px;" |
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  | style="padding:5px; width:500px;" |'''v.''' System generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand, including narrative
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  | style="padding:5px; width:500px;" |'''w.''' System can send on-screen output to printer or file
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  | style="padding:5px; width:500px;" |'''x.''' System allow users to query and print chain of custody
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  | style="padding:5px; width:500px;" |'''y.''' System supports report queries by fields/keys, status, completion, or other variables
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  | style="padding:5px; width:500px;" |'''z.''' System prohibits issuing reports outside of qualified areas
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  | style="padding:5px; width:500px;" |'''aa.''' System can generate reports from any data in tables
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  | style="padding:5px; width:500px;" |'''ab.''' System uses Microsoft Office tools for formatting reports
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  | style="padding:5px; width:500px;" |'''ac.''' System can automatically produce laboratory reports of findings and other written documents
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  | style="padding:5px; width:500px;" |'''ad.''' System can automatically produce individual and aggregate workload and productivity reports on all operational and administrative activities
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  | style="padding:5px; width:500px;" |'''ae.''' System can generate template letters for semi-annual reports
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  | style="padding:5px; width:500px;" |'''af.''' System permits database access using user-friendly report writing and inquiry tools
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  | style="padding:5px; width:500px;" |'''ag.''' System maintains template versions and renditions, allowing management and tracking of the template over time
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Latest revision as of 15:51, 21 October 2013

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