Difference between revisions of "User:Shawndouglas/sandbox"
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==Sandbox begins below== | ==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 '''Evaluation demonstration 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.''' Available for full demonstration (preferably online) and provider able to conduct an on-site demonstration | |||
| 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 | |- | ||
| | ! 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;" | | |||
|- | |||
|} | |||
|} | |||
Revision as of 17:05, 14 September 2013
This is my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead. |
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
- 1.2.1 IT General
|