Difference between revisions of "User:Shawndouglas/sandbox/sublevel1"

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<div class="nonumtoc">__TOC__</div>
{{Saved book
{{ombox
|title=Introduction to Quality and Quality Management Systems
| type      = notice
|subtitle=
| style    = width: 960px;
|cover-image=Time-Quality-Money.png
| text      = This is sublevel1 of 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>
|cover-color=#fffccc
| setting-papersize = A4
| setting-showtoc = 1
| setting-columns = 1
}}
}}


==Sandbox begins below==
==''Introduction to Quality and Quality Management Systems''==
The intention of this document is 1. to assist labs searching for a [[laboratory informatics]] product with identifying their system needs and 2. to help labs better determine if a specific vendor/product meets their requirements in the form of a request for information (RFI). The idea is to allow users to incorporate a standardized specifications sheet in their comparison of various laboratory informatics products.
{{ombox
 
| type      = content
This questionnaire lists the extensive requirements of a [[scientific data management system]] (SDMS). It attempts to be comprehensive and includes many items that do not apply to every lab. Additionally, some laboratories' requirements include a functionality item not common to other labs. The last section, 1.4 "Custom functions," is designed for the vendor to insert any additional functionality that doesn't fall under the categories provided.
| style   = width: 500px;
 
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
When referencing a particular item for someone else, use the req number, e.g. 1.3.200 for "The system architecture is modular or extensible and can easily and efficiently be modified to facilitate the addition of new functionality as business needs change."
 
===Requirement code and notes===
 
In responding to each requirement, the vendor must select a requirement code from the following:
 
* '''Y''': Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
* '''YC''': Meets requirement only with customization (additional code, using a third-party application, etc.)
* '''N''': Does not meet requirement
* '''I''': Informational response only, N/A
 
The vendor should ideally enter a requirement code and a response for each functionality question.
<!--
<div align="center">
{{ombox
| type      = notice
| style     = width: 960px; text-align: left;
| text      = To add the requirement code and vendor notes to a functionality item, look for this kind of code in the appropriate section:<br /><code><nowiki> | style="padding:5px; width:1200px;" |'''a.''' Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor</nowiki></code><br />
<code><nowiki> | style="background-color:white; padding:55px;" |</nowiki></code><br />
<code><nowiki>  | style="background-color:white;" |</nowiki></code><br />
...and add the applicable requirement code after the pipe (<nowiki>|</nowiki>) on the second line, and the vendor response after the pipe (<nowiki>|</nowiki>) on the third line.
}}
}}
</div>
The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.
-->
===Printing or saving===
The print/export options in the navigation on the far left give you a few options for saving this and other pages, printing them for later.
 
'''Note''': Tables are currently not being rendered in PDFs as we like through the MediaWiki [https://www.mediawiki.org/wiki/Extension:Collection Collection extension]. While we sure would love for you to make a PDF of this document, be warned: the tables don't format as intended, using either the "Create a book" or "Download as PDF" processes. For now you're best off selecting "Printable version" and printing that instead.
 
==1.0 Demonstration==
{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| 1.0 '''Demonstration'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.0.000 The system can be tried via an online and/or on-site demonstration.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
|}
 
==1.1 Information technology==
{|
| STYLE="vertical-align:top;"|
===1.1.1 General IT===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.1.1 '''General IT'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.100 The system operates with a traditional client-server architecture, with software installed on each machine that needs to access the system.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.101 The system operates with a web-based interface, hosted on a server and accessed via a web browser on most any machine.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.102 The system contains a single, centralized database that supports multiple sites and departments.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.103 The system's database conforms to the [[ODBC|Open Database Connectivity Standard]] (ODBC).'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.104 The system is designed so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.105 The system is designed to not be impacted by multiple users or failover processes.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.106 The system applies security features to all system files.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.107 The system applies log-in security to all servers and workstations accessing it.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.108 The system provides a workstation and server authentication mechanism.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.109 The system applies Secured Socket Layer (SSL) encryption on the web client interface.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.110 The system encrypts client passwords in a database, with support for multi-case and special characters.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.111 The system uses TCP/IP as its network transport.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.112 The system allows automated backup and restore capability without support intervention, as well as manual backups.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.113 The system maintains the transactional history of system administrators.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
 
===1.1.2 Hardware environment===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.1.2 '''Hardware environment'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|- 
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.200 The system proves compatible with a variety of hardware environments.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.201 The system can be utilized with a touch-screen.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
 
===1.1.3 Software environment===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.1.3 '''Software environment'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|- 
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.300 The system proves compatible with a variety of software environments.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.1.301 The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
|}
 
==1.2 Regulatory compliance and security==
{|
| STYLE="vertical-align:top;"|
===1.2.1 Regulatory compliance===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.2.1 '''Regulatory compliance'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|- 
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.100 The system can generate accurate and complete copies of records in both a human-readable and original electronic format for review and copying.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.101 The system supports [[21 CFR Part 11]] and [[EU Annex 11]] requirements, including log-in security, settable automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and full electronic signature.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.102 The system supports USP <232>/<233> requirements.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.103 The system supports [[GALP]] and/or [[GAMP]] standards.'''
|- 
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.104 The system supports the U.S. DoD 5015.2 Standard.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.105 The system maintains date- and time-stamped [[audit trail|audit trails]] of all data manipulation — such as changes to results, data analysis parameters, and methods — as consistent with all applicable regulations and standards, making the information available for review, copying, and reporting to authorized users.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.106 The system audit log retains all data, prohibits any deletions, and allows user comments.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.107 The system maintains audit trails at least as long as the records to which they pertain.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.108 The system provides additional persistent auditing capabilities, such as the audit of cancelled uploads and scheduled system functions.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.109 The system provides the ability to both automatically and manually add secure [[ELN feature#Electronic signatures|electronic signatures]] to documents and other data.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.110 The system can automatically validate and approve data prior to being moved to the main database.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
 
===1.2.2 Security===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.2.2 '''Security'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|- 
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.200 The system allows administrators and other authorized users to configure multiple levels of user rights and security by site location, department, group, [[LIMS feature#Configurable roles and security|role]], and/or specific function.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.201 The system allows administrators and users to reset user passwords.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.202 The system features and enforces adjustable rules concerning password complexity, reuse, and expiration.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.203 The system can lock a user out after a specified number of consecutive failed log-in attempts.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.204 The system provides the option for automatic user logout based on keyboard or mouse inactivity.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.205 The system makes authority checks to ensure only authorized individuals can use the system to perform an operation.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.206 The system allows authorized users to modify records, while also maintaining an audit trail of such actions.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.207 The system allows authorized users to manually delete records, while also maintaining an audit trail of such actions.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.208 The system prompts users to declare a reason for making changes to or deleting data in the system.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.209 The system allows authorized users to generate a detailed user access record.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.210 The system provides email notification of lockout, security access, and improper workstation access.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.211 The system provides a mechanism to allow a user read-only access to stored data.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.212 The system allows automatic and/or manual holds or locks to be placed on data to ensure it goes unaltered or remains retrievable during a retention period.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.213 The system can first feed data from connected non-CFR-compliant instruments through a virtual environment that is compliant (audit trailed, secure, versioned, etc.) before being stored.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.214 The system can control whether users are able to export data to portable long-term storage media like a USB flash drive or recordable DVD.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.215 The system employs automatic file encryption on stored data.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.2.216 The system employs checks to enforce permitted sequencing of steps and events.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
|}
 
==1.3 General system functions==
{|
| STYLE="vertical-align:top;"|
===1.3.1 General functions===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.3.1 '''General functions'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|- 
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.100 The system offers non-SDMS trained personnel the ability to easily access system data via an intuitive, user-friendly Windows-type graphical user interface (GUI) which permits the display of stored data.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.101 The system allows authorized users to configure their GUI to a specific language, character set, and time zone.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.102 The system permits remote access for users, system admins, and support agents.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.103 The system allows for the use of navigation keys to freely move from field to field.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.104 The system allows tabular data to be sorted and filtered.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.105 The system can send on-screen output to a printer or file without contradicting read-only statuses.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.106 The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.107 The system uses human-readable metadata tags to better describe, index, and store all captured and archived data.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.108 The system can generate metadata tags via derived value rules.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.109 The system allows users to manually add metadata tags to files.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.110 The system provides full metadata, keyword, and field [[LIMS feature#Query capability|search capability]], including the use of multiple search criteria.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.111 The system allows users to search for similar records based upon a set of metadata tag values.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.112 The system allows users to build, save, and edit queries for future use.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.113 The system can automate the search for and extraction of pertinent data, including the export of that data to external applications for additional processing and calculation.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.114 The system allows users to attach comments to data and files.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.115 The system's file viewer/explorer allow users to view native, processed, and archived data in its native file structure.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.116 The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.117 The system [[LIMS feature#Alarms and/or alerts|notifies users]] of events like the scheduling and completion of tasks.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.118 The system includes the ability to set up alerts via email.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.119 The system offers integrated or online user help screens.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.120 The system includes data analysis and calculation tools.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
 
===1.3.2 Configuration and customization===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.3.2 '''Configuration and customization'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px; text-align:center; font-style:italic;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|- 
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.200 The system architecture is modular or extensible and can easily and efficiently be modified to facilitate the addition of new functionality as business needs change.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.201 The system has an application programming interface (API) or a similar software development toolkit (SDK). If web-based, the API should support Simple Object Access Protocol (SOAP), representational state transfer (REST), or both.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.202 The system allows a user to [[LIMS feature#Customizable fields and/or interface|independently add fields]] without requiring reconfiguration of the system, even after routine upgrades and maintenance.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.203 The system allows for the integration of additional printers and scanners both locally and externally.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
 
===1.3.3 Data capture===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.3.3 '''Data capture'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px; text-align:center; font-style:italic;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|- 
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.300 The system can manage and store both sample- and non-sample-related data, including images from microscopes, GCMS scans of peaks, PDF files, spreadsheets, or even raw data files from instrument runs for later processing.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.301 The system can manage and store media objects like digital photos, bitmaps, movies, and audio files.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.302 The system allows multiple native instruments and users to enter data into the system simultaneously without disruption.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.303 The system can interface with and [[LIMS feature#Import data|import existing data]] from other databases and file shares.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.304 The system supports data capture from a Citrix-based environment.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.305 The system allows file indexes to be stored centrally while associated files are stored geographically.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.306 The system allows users to organize captured data by project, date, location, instrument, etc.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.307 The system can route captured data based upon specified metadata tags.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.308 The system allows full on-screen review and approval of native instrument data prior to database commitment.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.309 The system keeps all captured data and its format intact and captures modifications of that data as a version, including date and time of those modifications, for regulatory purposes.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.310 The system has a tool that allows users to capture data printed to it as a searchable PDF file.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.311 The system can automatically normalize and store incoming data to a technology-neutral format like XML.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.312 The system allows incoming and entered files to be converted into other open formats like JCAMP-DX, TraML, mzML, mzXML, AnIML, pepXML, and protXML.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.313 The system can capture and store native instrument and processed data based on a scheduled time or a real-time event, such as upon file creation.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.314 The system allows users to manually upload instrument data files that are not part of a scheduled upload.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.315 The system allows for the specification of a retention period for captured native instrument and processed data and can enact it based on date-based metadata fields or a future event.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.316 The system can remove data from client machines upon upload and/or backup, based on a schedule or retention policy.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.317 The system allows users to review, restore, and reprocess original native instrument data on the original instrument acquisition software.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.318 The system allows users to open and view captured native instrument files without restoring them.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.319 The system allows captured processed data to be reused by other applications without having to reprocess it.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.320 The system provides a method to extract data points from captured processed data and present it in a human-readable format.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.321 The system can parse captured data files containing specified metadata into a live results table.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
 
===1.3.4 Data archiving and migration===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.3.4 '''Data archiving and migration'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px; text-align:center; font-style:italic;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|- 
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.400 The system provides data archiving functionality for all contained data, without requiring an off-line mode.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.401 The system allows for a configurable scheduled archive, not requiring human interaction with the data to be archived.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.402 The system allows for a scheduled archive of data directly captured from a specific native instrument.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.403 The system permits native instrument data to be archived and restored with its original directory structure.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.404 The system allows for the specification of a retention period for archived and migrated data and can enact it based on date-based metadata fields or a future event.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.405 The system ensures that held or locked native instrument data not captured during a scheduled archive will be captured during the next scheduled archive.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.406 The system can perform archive and restore functions simultaneously with data capture and viewing functions, without disruption.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.407 The system allows native instrument and processed data migrated from an old SDMS version to be backed up and restored without alteration.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
 
===1.3.5 Instruments===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.3.5 '''Instruments'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px; text-align:center; font-style:italic;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|- 
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.500 The system bilaterally [[LIMS feature#Instrument interfacing and management|interfaces]] with instruments and related software based on the Unix and Windows platforms.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.501 The system can download data directly from laboratory instruments.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.502 The system can track and report on the usage of attached laboratory instruments.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.503 The system can automatically (or manually allow an authorized user to) remove an instrument from potential use when it falls out of tolerance limit or requires scheduled calibration.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.504 The system maintains a reportable database of preventative maintenance, calibration, and repair records for attached laboratory instruments.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.505 The system can schedule calibration, verification, and maintenance tasks on attached instruments and make that schedule available for viewing.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.506 The system allows users to create and edit instrument maintenance profiles.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
 
===1.3.6 External system interfaces===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.3.6 '''External system interfaces'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px; text-align:center; font-style:italic;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.600. The system supports a library of common electronic data deliverable (EDD) formats.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.601 The system can transfer data to and from other record management systems.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.602 The system [[LIS feature#Third-party software integration|integrates]] with Microsoft Exchange services.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.603 The system can [[LIMS feature#Import data|import data]] from and export data to Microsoft Word, Excel, Access, and/or Powerpoint.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.604 The system can interface with non-Microsoft programs.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.605 The system can interface with enterprise resource planning (ERP) systems.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.606 The system can interface with internal and external laboratory systems like laboratory information management systems (LIMS) and electronic laboratory notebooks (ELNs).'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.607 The system can leverage the application programming interface (API) of other systems to establish integration between systems.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.608 The system provides a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.609 The system supports [[LIMS feature#Mobile device integration|dockable mobile devices]] and handles information exchange between them and the system.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.610 The system supports the use of optical character recognition (OCR) software.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}


===1.3.7 Reporting===
;1. What is quality?
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
:''Key terms''
|-
:[[Quality (business)|Quality]]
  ! colspan="2" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.3.7 '''Reporting'''
:[[Quality assurance]]
|-
:[[Quality control]]
  ! style="color:brown; background-color:#ffffee; width:100px; text-align:center; font-style:italic;"| Requirement code
:''The rest''
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
:[[Data quality]]
|-
:[[Information quality]]
  ! style="padding:5px;" |
:[[Nonconformity (quality)|Nonconformity]]
  | style="padding:5px; width:1200px;" |'''1.3.700 The system includes a versatile report writer and forms generator that can generate reports from any data in the system.'''
:[[Service quality]]
|-
;2. Processes and improvement
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
:[[Business process]]
  | style="background-color:white; padding:55px;" |
:[[Process capability]]
|-
:[[Risk management]]
  ! style="padding:5px;" |
:[[Workflow]]
  | style="padding:5px; width:1200px;" |'''1.3.701 The system can interface with a third-party reporting application.'''
;3. Mechanisms for quality
|-
:[[Acceptance testing]]
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
:[[Conformance testing]]
  | style="background-color:white; padding:55px;" |
:[[Clinical quality management system]]
|-
:[[Continual improvement process]]
  ! style="padding:5px;" |
:[[Corrective and preventive action]]
  | style="padding:5px; width:1200px;" |'''1.3.702 The system allows the development of [[LIMS feature#Custom reporting|custom templates]] for different types of reports.'''
:[[Good manufacturing practice]]
|-
:[[Malcolm Baldrige National Quality Improvement Act of 1987]]
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
:[[Quality management]]
  | style="background-color:white; padding:55px;" |
:[[Quality management system]]
|-
:[[Total quality management]]
  ! style="padding:5px;" |
;4. Quality standards
  | style="padding:5px; width:1200px;" |'''1.3.703 The system maintains template versions and renditions, allowing management and tracking of the template over time.'''
:[[ISO 9000]]
|-
:[[ISO 13485]]
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
:[[ISO 14000|ISO 14001]]
  | style="background-color:white; padding:55px;" |
:[[ISO 15189]]
|-
:[[ISO/IEC 17025]]
  ! style="padding:5px;" |
:[[ISO/TS 16949]]
  | style="padding:5px; width:1200px;" |'''1.3.704 The system uses Microsoft Office tools for formatting reports.'''
;5. Quality in software
|-
:[[Software quality]]
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
:[[Software quality assurance]]
  | style="background-color:white; padding:55px;" |
:[[Software quality management]]
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.705 The system provides multiple ways to visualize data in reports, including graphs, trend bars, pie charts, spectrum, etc. for the purpose of presenting information and identifying trends.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.706 The system makes graphic and tabular data vector-scalable in reports.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.707 The system allows for internal hyperlinking to source data in reports.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.708 The system allows users to manually adjust inaccurate data parsing routines for reports.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.709 The system can indicate whether a report is preliminary, amended, corrected, or final while retaining revision history.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.710 The system can automatically generate laboratory reports of findings and other written documents.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.711 The system provides an ad-hoc web reporting interface to report on user-selected criteria.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.712 The system can automatically generate and post periodic static summary reports on an internal web server.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.713 The system can transmit reports 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; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.714 The system supports PDF/A, an ISO-standardized version of the Portable Document Format (PDF).'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.715 The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.716 The system provides printer-friendly audit trails for cleaner reporting of audit data.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.717 The system provides an interface for external clients to search, generate, and view processed data reports based on metadata tags.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.3.718 The system provides document workflow management tools for streamlining their creation, review, modification, and approval.'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
|}
|}


==1.4 Custom requirements==
<!--Place all category tags here-->
{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.4 '''Custom requirements'''
|-
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:1200px;"| Requirement # and requirement
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.4.000'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.4.001'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.4.002'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.4.003'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.4.004'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.4.005'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.4.006'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.4.007'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.4.008'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-
  ! style="padding:5px;" |
  | style="padding:5px; width:1200px;" |'''1.4.009'''
|-
  | style="background-color:white; width:100px; text-align:center; font-style:italic; padding:55px;"| Response:
  | style="background-color:white; padding:55px;" |
|-  
|}
|}

Latest revision as of 19:46, 9 February 2022

Introduction to Quality and Quality Management Systems
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Introduction to Quality and Quality Management Systems

This book should not be considered complete until this message box has been removed. This is a work in progress.

The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.

1. What is quality?
Key terms
Quality
Quality assurance
Quality control
The rest
Data quality
Information quality
Nonconformity
Service quality
2. Processes and improvement
Business process
Process capability
Risk management
Workflow
3. Mechanisms for quality
Acceptance testing
Conformance testing
Clinical quality management system
Continual improvement process
Corrective and preventive action
Good manufacturing practice
Malcolm Baldrige National Quality Improvement Act of 1987
Quality management
Quality management system
Total quality management
4. Quality standards
ISO 9000
ISO 13485
ISO 14001
ISO 15189
ISO/IEC 17025
ISO/TS 16949
5. Quality in software
Software quality
Software quality assurance
Software quality management


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