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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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| | 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 '''Evaluation demonstration 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.''' Available for full demonstration (preferably online) and provider able to 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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| |}
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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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.2.2 '''Hardware environment'''
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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.''' 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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| ! colspan="3" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.2.3 '''Software environment'''
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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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| | 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;" |
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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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| ! colspan="3" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.3 '''Regulatory compliance requirements'''
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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.''' 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| | 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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| |}
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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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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| ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.4.1 '''General'''
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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.''' 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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| | 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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| | 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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| | 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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| | 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="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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| | 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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| | 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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| | style="padding:5px; width:500px;" |'''i.''' 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="padding:5px; width:500px;" |'''j.''' 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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| | style="padding:5px; width:500px;" |'''k.''' 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="padding:5px; width:500px;" |'''l.''' 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="padding:5px; width:500px;" |'''m.''' 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="padding:5px; width:500px;" |'''n.''' 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="padding:5px; width:500px;" |'''o.''' 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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| | style="padding:5px; width:500px;" |'''p.''' 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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| | style="padding:5px; width:500px;" |'''q.''' 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="padding:5px; width:500px;" |'''r.''' 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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| |}
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