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

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==Sandbox begins below==
==Sandbox begins below==
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.


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.
{{Infobox journal article
 
|name        =
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."
|image        =
 
|alt          = <!-- Alternative text for images -->
===Requirement code and notes===
|caption      =
 
|title_full  = How could the ethical management of health data in the medical field inform police use of DNA?
In responding to each requirement, the vendor must select a requirement code from the following:
|journal      = ''Frontiers in Public Health''
 
|authors      = Krikorian, Gaelle; Vailly, Joëlle
* '''Y''': Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
|affiliations = Institut de recherche interdisciplinaire sur les enjeux sociaux (IRIS)
* '''YC''': Meets requirement only with customization (additional code, using a third-party application, etc.)
|contact      = Email: gaelle.krikorian@gmail.com
* '''N''': Does not meet requirement
|editors      = Lefèvre, Thomas
* '''I''': Informational response only, N/A
|pub_year    = 2018
 
|vol_iss      = '''6'''
The vendor should ideally enter a requirement code and a response for each functionality question.
|pages        = 154
<!--
|doi          = [http://10.3389/fpubh.2018.00154 10.3389/fpubh.2018.00154]
<div align="center">
|issn        = 2296-2565
{{ombox
|license     = [http://creativecommons.org/licenses/by/4.0/ Creative Commons Attribution 4.0 International]
| type      = notice
|website      = [https://www.frontiersin.org/articles/10.3389/fpubh.2018.00154/full https://www.frontiersin.org/articles/10.3389/fpubh.2018.00154/full]
| style    = width: 960px; text-align: left;
|download    = [https://www.frontiersin.org/articles/10.3389/fpubh.2018.00154/pdf https://www.frontiersin.org/articles/10.3389/fpubh.2018.00154/pdf] (PDF)
| 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 />
{{ombox
<code><nowiki>  | style="background-color:white;" |</nowiki></code><br />
| type      = content
...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.
| style    = width: 500px;
| text      = This article should not be considered complete until this message box has been removed. This is a work in progress.
}}
}}
</div>
==Introduction==
-->
Various events paved the way for the production of ethical norms regulating biomedical practices, from the Nuremberg Code (1947)—produced by the international trial of Nazi regime leaders and collaborators—and the Declaration of Helsinki by the World Medical Association (1964) to the invention of the term “bioethics” by American biologist Van Rensselaer Potter.<ref name="PotterBio70">{{cite journal |title=Bioethics, the science of survival |journal=Perspectives in Biology and Medicine |author=Potter, V.R. |volume=14 |issue=1 |pages=127–53 |year=1970 |doi=10.1353/pbm.1970.0015}}</ref> The ethics of biomedicine has given rise to various controversies—particularly in the fields of newborn screening<ref name=VaillyTheBirth13">{{cite book |title=The Birth of a Genetics Policy: Social Issues of Newborn Screening |author=Vailly, J. |publisher=Routledge |pages=240 |year=2013 |isbn=9781472422729}}</ref>, prenatal screening<ref name="IsambertÉthique80">{{cite journal |title=Éthique et génétique: De l'utopie eugénique au contrôle des malformations congénitales |journal=Revue française de sociologie |author=Isambert, F.A. |volume=21 |issue=3 |pages=331–54 |year=1980 |doi=10.2307/3320930}}</ref>, and cloning<ref name="PulmanLesEnjeux05">{{cite journal |title=Les enjeux du clonage |journal=Revue française de sociologie |author=Pulman, B. |volume=46 |issue=3 |pages=413–42 |year=2005 |doi=10.3917/rfs.463.0413}}</ref>—resulting in the institutionalization of ethical questions in the biomedical world of genetics. In 1994, France passed legislation (commonly known as the “bioethics laws”) to regulate medical practices in genetics. The medical community has also organized itself in order to manage ethical issues relating to its decisions, with a view to handling “practices with many strong uncertainties” and enabling clinical judgments and decisions to be made not by individual practitioners but rather by multidisciplinary groups drawing on different modes of judgment and forms of expertise.<ref name="BourretDécision08">{{cite journal |title=Décision et jugement médicaux en situation de forte incertitude : l’exemple de deux pratiques cliniques à l’épreuve de la génétique |journal=Sciences sociales et santé |author=Bourret, P.; Rabeharisoa, V. |volume=26 |issue=1 |pages=128 |year=2008 |doi=10.3917/sss.261.0033}}</ref> Thus, the biomedical approach to genetics has been characterized by various debates and the existence of public controversies.
===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===
In the judicial sphere, the situation is very different. Since the end of the 1990s, developments in biomedical research have led to genetic data being used in police work and legal proceedings. Today, [[forensic science]] is omnipresent in investigations, not just in complex criminal cases but also routinely in cases of “minor” or “mass” delinquency. Genetics, which certainly receives the most media coverage among the techniques involved<ref name="BrewerMedia09">{{cite journal |title=Media Use and Public Perceptions of DNA Evidence |journal=Science Communication |author=Brewer, P.R.; Ley, B.L. |volume=32 |issue=1 |pages=93–117 |year=2009 |doi=10.1177/1075547009340343}}</ref>, has taken on considerable importance.<ref name="WilliamsGenetic08">{{cite book |title=Genetic Policing: The Uses of DNA in Police Investigations |author=Williams, R.; Johnson, P. |publisher=Willan |pages=208 |year=2008 |isbn=9781843922049}}</ref> However, although very similar techniques are used in biomedicine and police work (DNA amplification, [[sequencing]], etc.), the forms of collective management surrounding them are very different, as well as the ethico-legal frameworks and their evolution, as this text will demonstrate.
{| 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==
'''Keywords''': DNA, police, ethics, genetic technologies, criminal investigations
{|
| 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===
==Nature of the information and genetic data produced in the police sphere==
{| 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===
In police work in France, data produced by DNA are currently compiled and used in two different ways: first, to create files on individuals in the FNAEG or ''Fichier national automatisé des empreintes génétiques'' (national automated DNA database) and, second, in order to obtain information about perpetrators of crimes (their appearance, their origin, their kinship links to other individuals).
{| 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===
Police use of DNA has been allowed in France since the 1998 law providing for the creation of the FNAEG. A DNA profile corresponds to a “specific individual alphanumeric combination”<ref name="CabalRapport01">{{cite book |title=Rapport sur la valeur scientifique de l'utilisation des empreintes génétiques dans le domaine judiciaire |author=Cabal, C.; Le Déaut, J.-Y.; Revol, H. |publisher=Assemblée nationale |year=2001 |isbn=2111150177}}</ref> that is the numerical encoding of analysis of DNA segments. This profile is the result of analysis of DNA fragments using genetic markers. This analysis can be carried out on a minute amount of genetic material (saliva, blood, sperm, hair, contact, etc.). It identifies the presence of sequences specific to an individual that differentiate them from any other person (with the exception of an identical twin) but that are not supposed to provide any phenotypical information (about appearance, geographical origin, or diseases).{{efn|The Order of 10 August 2015 increased the number of markers analyzed to 21; policemen and analysis laboratories had three years to comply with this new requirement.}} Such profiles therefore make individuals “identifiable in their uniqueness.”<ref name="BonniolL'ADN14">{{cite journal |title=L’ADN au service d’une nouvelle quête des ancêtres? |journal=Civilisations |author=Bonniol, J.-L.; Darlu, P. |volume=63 |pages=201–19 |year=2014 |doi=10.4000/civilisations.3747}}</ref> During investigations, DNA is collected from suspects or unidentified stains left on crime scenes or people and the results of this analysis are entered into the database. Identification through the FNAEG was originally restricted to a limited number of crimes—those of a sexual nature, as part of the law relating to the prevention and punishment of sexual crimes and the protection of minors. This remit has progressively been extended to include the vast majority of crimes and offences{{efn|Act n°98-468 of 17 June 1998 relative to the punishment of sexual crimes and the protection of minors introduced article 706-54 into the Code of Criminal Procedure making provision for the creation of an automated national database to centralize the DNA profiles of persons convicted of offences of a sexual nature. The remit of the database was then extended on several occasions. In 2001, it included serious crimes against persons. In 2003, the law on internal security extended it to persons convicted of or implicated in crimes and offences against persons or property.}}, leading to the routine use of DNA in investigations.{{efn|Collecting DNA samples in investigations is now the rule. An ''ad hoc'' body of staff has been trained over the past 15 years that almost systematically processes crime scenes.}} As a result of this evolution, there has been a substantial increase in the number of persons with files in the FNAEG, more than three million as of late 2015.{{efn|This figure was provided to the French Parliament by the Ministry of the Interior following a question by parliamentarian Sergio Coronado (member of the “Ecologist” parliamentary group) (http://questions.assemblee-nationale.fr/q14/14-79728QE.htm).}}
{| 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===
==Footnotes==
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{{reflist|group=lower-alpha}}
|-
  ! 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===
==References==
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{{Reflist|colwidth=30em}}
|-
  ! 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===
==Notes==
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
This presentation is faithful to the original, with only a few minor changes to presentation. In some cases important information was missing from the references, and that information was added. Footnotes were originally numbered but have been converted to lowercase alpha for this version.
|-
  ! colspan="2" style="color:DarkSlateGray;text-align:left; padding-left:40px;"| 1.3.7 '''Reporting'''
|-
  ! 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;" |'''1.3.700 The system includes a versatile report writer and forms generator that can generate reports from any 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;" |'''1.3.701 The system can interface with a third-party reporting application.'''
|-
  | 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;" |'''1.3.702 The system allows the development of [[LIMS feature#Custom reporting|custom templates]] for different types of 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;" |'''1.3.703 The system maintains template versions and renditions, allowing management and tracking of the template over time.'''
|-
  | 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;" |'''1.3.704 The system uses Microsoft Office tools for formatting 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;" |'''1.3.705 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-->
{|
[[Category:LIMSwiki journal articles (added in 2018)‎]]
| STYLE="vertical-align:top;"|
[[Category:LIMSwiki journal articles (all)‎]]
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
[[Category:LIMSwiki journal articles on forensic science]]
|-
[[Category:LIMSwiki journal articles on health informatics‎‎]]
  ! 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;" |
|-
|}
|}

Revision as of 21:38, 9 August 2018

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Full article title How could the ethical management of health data in the medical field inform police use of DNA?
Journal Frontiers in Public Health
Author(s) Krikorian, Gaelle; Vailly, Joëlle
Author affiliation(s) Institut de recherche interdisciplinaire sur les enjeux sociaux (IRIS)
Primary contact Email: gaelle.krikorian@gmail.com
Editors Lefèvre, Thomas
Year published 2018
Volume and issue 6
Page(s) 154
DOI 10.3389/fpubh.2018.00154
ISSN 2296-2565
Distribution license Creative Commons Attribution 4.0 International
Website https://www.frontiersin.org/articles/10.3389/fpubh.2018.00154/full
Download https://www.frontiersin.org/articles/10.3389/fpubh.2018.00154/pdf (PDF)
This article should not be considered complete until this message box has been removed. This is a work in progress.

Introduction

Various events paved the way for the production of ethical norms regulating biomedical practices, from the Nuremberg Code (1947)—produced by the international trial of Nazi regime leaders and collaborators—and the Declaration of Helsinki by the World Medical Association (1964) to the invention of the term “bioethics” by American biologist Van Rensselaer Potter.[1] The ethics of biomedicine has given rise to various controversies—particularly in the fields of newborn screening[2], prenatal screening[3], and cloning[4]—resulting in the institutionalization of ethical questions in the biomedical world of genetics. In 1994, France passed legislation (commonly known as the “bioethics laws”) to regulate medical practices in genetics. The medical community has also organized itself in order to manage ethical issues relating to its decisions, with a view to handling “practices with many strong uncertainties” and enabling clinical judgments and decisions to be made not by individual practitioners but rather by multidisciplinary groups drawing on different modes of judgment and forms of expertise.[5] Thus, the biomedical approach to genetics has been characterized by various debates and the existence of public controversies.

In the judicial sphere, the situation is very different. Since the end of the 1990s, developments in biomedical research have led to genetic data being used in police work and legal proceedings. Today, forensic science is omnipresent in investigations, not just in complex criminal cases but also routinely in cases of “minor” or “mass” delinquency. Genetics, which certainly receives the most media coverage among the techniques involved[6], has taken on considerable importance.[7] However, although very similar techniques are used in biomedicine and police work (DNA amplification, sequencing, etc.), the forms of collective management surrounding them are very different, as well as the ethico-legal frameworks and their evolution, as this text will demonstrate.

Keywords: DNA, police, ethics, genetic technologies, criminal investigations

Nature of the information and genetic data produced in the police sphere

In police work in France, data produced by DNA are currently compiled and used in two different ways: first, to create files on individuals in the FNAEG or Fichier national automatisé des empreintes génétiques (national automated DNA database) and, second, in order to obtain information about perpetrators of crimes (their appearance, their origin, their kinship links to other individuals).

Police use of DNA has been allowed in France since the 1998 law providing for the creation of the FNAEG. A DNA profile corresponds to a “specific individual alphanumeric combination”[8] that is the numerical encoding of analysis of DNA segments. This profile is the result of analysis of DNA fragments using genetic markers. This analysis can be carried out on a minute amount of genetic material (saliva, blood, sperm, hair, contact, etc.). It identifies the presence of sequences specific to an individual that differentiate them from any other person (with the exception of an identical twin) but that are not supposed to provide any phenotypical information (about appearance, geographical origin, or diseases).[a] Such profiles therefore make individuals “identifiable in their uniqueness.”[9] During investigations, DNA is collected from suspects or unidentified stains left on crime scenes or people and the results of this analysis are entered into the database. Identification through the FNAEG was originally restricted to a limited number of crimes—those of a sexual nature, as part of the law relating to the prevention and punishment of sexual crimes and the protection of minors. This remit has progressively been extended to include the vast majority of crimes and offences[b], leading to the routine use of DNA in investigations.[c] As a result of this evolution, there has been a substantial increase in the number of persons with files in the FNAEG, more than three million as of late 2015.[d]

Footnotes

  1. ↑ The Order of 10 August 2015 increased the number of markers analyzed to 21; policemen and analysis laboratories had three years to comply with this new requirement.
  2. ↑ Act n°98-468 of 17 June 1998 relative to the punishment of sexual crimes and the protection of minors introduced article 706-54 into the Code of Criminal Procedure making provision for the creation of an automated national database to centralize the DNA profiles of persons convicted of offences of a sexual nature. The remit of the database was then extended on several occasions. In 2001, it included serious crimes against persons. In 2003, the law on internal security extended it to persons convicted of or implicated in crimes and offences against persons or property.
  3. ↑ Collecting DNA samples in investigations is now the rule. An ad hoc body of staff has been trained over the past 15 years that almost systematically processes crime scenes.
  4. ↑ This figure was provided to the French Parliament by the Ministry of the Interior following a question by parliamentarian Sergio Coronado (member of the “Ecologist” parliamentary group) (http://questions.assemblee-nationale.fr/q14/14-79728QE.htm).

References

  1. ↑ Potter, V.R. (1970). "Bioethics, the science of survival". Perspectives in Biology and Medicine 14 (1): 127–53. doi:10.1353/pbm.1970.0015. 
  2. ↑ Vailly, J. (2013). The Birth of a Genetics Policy: Social Issues of Newborn Screening. Routledge. pp. 240. ISBN 9781472422729. 
  3. ↑ Isambert, F.A. (1980). "Éthique et génétique: De l'utopie eugénique au contrôle des malformations congénitales". Revue française de sociologie 21 (3): 331–54. doi:10.2307/3320930. 
  4. ↑ Pulman, B. (2005). "Les enjeux du clonage". Revue française de sociologie 46 (3): 413–42. doi:10.3917/rfs.463.0413. 
  5. ↑ Bourret, P.; Rabeharisoa, V. (2008). "Décision et jugement médicaux en situation de forte incertitude : l’exemple de deux pratiques cliniques à l’épreuve de la génétique". Sciences sociales et santé 26 (1): 128. doi:10.3917/sss.261.0033. 
  6. ↑ Brewer, P.R.; Ley, B.L. (2009). "Media Use and Public Perceptions of DNA Evidence". Science Communication 32 (1): 93–117. doi:10.1177/1075547009340343. 
  7. ↑ Williams, R.; Johnson, P. (2008). Genetic Policing: The Uses of DNA in Police Investigations. Willan. pp. 208. ISBN 9781843922049. 
  8. ↑ Cabal, C.; Le Déaut, J.-Y.; Revol, H. (2001). Rapport sur la valeur scientifique de l'utilisation des empreintes génétiques dans le domaine judiciaire. Assemblée nationale. ISBN 2111150177. 
  9. ↑ Bonniol, J.-L.; Darlu, P. (2014). "L’ADN au service d’une nouvelle quête des ancêtres?". Civilisations 63: 201–19. doi:10.4000/civilisations.3747. 

Notes

This presentation is faithful to the original, with only a few minor changes to presentation. In some cases important information was missing from the references, and that information was added. Footnotes were originally numbered but have been converted to lowercase alpha for this version.

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