Difference between revisions of "User:Shawndouglas/sandbox"
From LIMSWiki
Jump to navigationJump to searchShawndouglas (talk | contribs)  (→Citation:  Added content.)  | 
				Shawndouglas (talk | contribs)   (Saving content. Adding more.)  | 
				||
| Line 8: | Line 8: | ||
==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
 
 
 
  | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||







