Difference between revisions of "21 CFR Part 11"

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In March 1997, the FDA issued Part 11 regulations which, in the words of the FDA, were "intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health."<ref name="RegInfo_Part11_FDA">{{cite web |url=http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm |title=Part 11, Electronic Records; Electronic Signatures — Scope and Application |publisher=U.S. Food and Drug Administration |date=August 2003 |accessdate=06 April 2013}}</ref> Various keynote speeches by FDA insiders early in the 21st century (in addition to compliance guides and draft guidance documents)<ref name="RegInfo_Part11_FDA" /> as well as strong efforts by the FDA to motivate industry to move to e-filing<ref name="IWEfilingFDA">{{cite web |url=http://www.informationweek.com/fda-moving-to-e-filing/6500937 |title=FDA Moving To E-Filing |author=Greenemeier, Larry |publisher=InformationWeek |date=25 February 2002 |accessdate=06 April 2013}}</ref> resulted in many companies like Eli Lilly<ref name="IWLillyPart11">{{cite web |url=http://www.informationweek.com/lilly-cures-inefficiency-with-it/6501017 |title=Lilly Cures Inefficiency With IT |author=Greenemeier, Larry |publisher=InformationWeek |date=18 February 2002 |accessdate=06 April 2013}}</ref>, [[Agilent Technologies, Inc.|Agilent Technologies]]<ref name="LabNetAgilent00">{{cite web |url=http://www.laboratorynetwork.com/doc/Agilent-Introduces-Security-Pack-for-Analytic-0001 |title=Agilent Introduces Security Pack for Analytical Laboratories |publisher=Laboratory Network |date=20 June 2000 |accessdate=06 April 2013}}</ref>, and other businesses rapidly being forced to change their methods and systems to adapt to the new standards.<ref name="RegInfo_Part11_FDA" /><ref name="CEPart11Art">{{cite web |url=http://www.controleng.com/single-article/i-m-from-the-government-and-i-m-here-to-help-you/61fedbc69297fc6965c6d8840871e085.html |title='I'm from the Government, and I'm Here to Help You!' |author=Harrold, Dave |publisher=Control Engineering |date=01 April 2002 |accessdate=06 April 2013}}</ref>
In March 1997, the FDA issued Part 11 regulations which, in the words of the FDA, were "intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health."<ref name="RegInfo_Part11_FDA">{{cite web |url=http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm |title=Part 11, Electronic Records; Electronic Signatures — Scope and Application |publisher=U.S. Food and Drug Administration |date=August 2003 |accessdate=06 April 2013}}</ref> Various keynote speeches by FDA insiders early in the 21st century (in addition to compliance guides and draft guidance documents)<ref name="RegInfo_Part11_FDA" /> as well as strong efforts by the FDA to motivate industry to move to e-filing<ref name="IWEfilingFDA">{{cite web |url=http://www.informationweek.com/fda-moving-to-e-filing/6500937 |title=FDA Moving To E-Filing |author=Greenemeier, Larry |publisher=InformationWeek |date=25 February 2002 |accessdate=06 April 2013}}</ref> resulted in many companies like Eli Lilly<ref name="IWLillyPart11">{{cite web |url=http://www.informationweek.com/lilly-cures-inefficiency-with-it/6501017 |title=Lilly Cures Inefficiency With IT |author=Greenemeier, Larry |publisher=InformationWeek |date=18 February 2002 |accessdate=06 April 2013}}</ref>, [[Agilent Technologies, Inc.|Agilent Technologies]]<ref name="LabNetAgilent00">{{cite web |url=http://www.laboratorynetwork.com/doc/Agilent-Introduces-Security-Pack-for-Analytic-0001 |title=Agilent Introduces Security Pack for Analytical Laboratories |publisher=Laboratory Network |date=20 June 2000 |accessdate=06 April 2013}}</ref>, and other businesses rapidly being forced to change their methods and systems to adapt to the new standards.<ref name="RegInfo_Part11_FDA" /><ref name="CEPart11Art">{{cite web |url=http://www.controleng.com/single-article/i-m-from-the-government-and-i-m-here-to-help-you/61fedbc69297fc6965c6d8840871e085.html |title='I'm from the Government, and I'm Here to Help You!' |author=Harrold, Dave |publisher=Control Engineering |date=01 April 2002 |accessdate=06 April 2013}}</ref>


However, many entities expressed concerns about the Title 11 conditions, including concerns the regulations would "unnecessarily restrict" the use of technology, add significant compliance costs beyond what was intended, and stifle technological innovation while reducing public health benefit.<ref name="RegInfo_Part11_FDA" /> In November 2002, the FDA released the guidance document "Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records" to the public for commenting.<ref name="CEGuideDocFDA1">{{cite web |url=http://www.controleng.com/search/search-single-display/fda-releases-21-cfr-part-11-guidance-document/5edbb001e1.html |title=FDA releases 21 CFR Part 11 guidance document |publisher=Control Engineering |date=03 January 2003 |accessdate=06 April 2013}}</ref> On February 3, 2003, the FDA withdrew that document, stating "we wanted to minimize industry time spent reviewing and commenting on the draft guidance when that draft guidance may no longer represent our approach under the [current good manufacturing practice] initiative," adding it would afterwards "intend to exercise enforcement discretion with regard to certain part 11 requirements."<ref name="RegInfo_Part11_FDA" /> Further guidance documents were withdrawn later that month, culminating in a final guidance document in August 2003 stating the government body would re-examine Part 11 and make necessary changes.<ref name="RegInfo_Part11_FDA" /><ref name="inPharmaFDAFinal03">{{cite web |url=http://www.in-pharmatechnologist.com/Drug-Delivery/FDA-plans-to-amend-21-CFR-Part-11-rules |title=FDA plans to amend 21 CFR Part 11 rules |publisher=in-Pharma Technologist |date=05 September 2003 |accessdate=06 April 2013}}</ref>
However, many entities expressed concerns about the Title 11 conditions, including concerns the regulations would "unnecessarily restrict" the use of technology, add significant compliance costs beyond what was intended, and stifle technological innovation while reducing public health benefit.<ref name="RegInfo_Part11_FDA" /> In November 2002, the FDA released the guidance document "Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records" to the public for commenting.<ref name="CEGuideDocFDA1">{{cite web |url=http://www.controleng.com/search/search-single-display/fda-releases-21-cfr-part-11-guidance-document/5edbb001e1.html |title=FDA releases 21 CFR Part 11 guidance document |publisher=Control Engineering |date=03 January 2003 |accessdate=06 April 2013}}</ref> On February 3, 2003, the FDA withdrew that document, stating "we wanted to minimize industry time spent reviewing and commenting on the draft guidance when that draft guidance may no longer represent our approach under the [current good manufacturing practice] initiative," adding it would afterwards "intend to exercise enforcement discretion with regard to certain part 11 requirements."<ref name="RegInfo_Part11_FDA" /> Further guidance documents were withdrawn later that month, culminating in a final guidance document in August 2003 stating the government body would re-examine Part 11 and make necessary changes.<ref name="RegInfo_Part11_FDA" /><ref name="inPharmaFDAFinal03">{{cite web |url=http://www.in-pharmatechnologist.com/Drug-Delivery/FDA-plans-to-amend-21-CFR-Part-11-rules |title=FDA plans to amend 21 CFR Part 11 rules |publisher=in-Pharma Technologist |date=05 September 2003 |accessdate=06 April 2013}}</ref> This change in policy led many IT members in the pharmaceutical and life sciences industry in late-2004 to state one of the key problems they face is the lack of clear guidelines from the FDA about what is required for compliance.<ref name="SNSSurveyUKIT">{{cite web |url=http://snseurope.info/article/12833/Complying-with-US-Food-and-Drug-Administration(FDA)-data-regulations-is-proving-a-struggle-for-IT-departments-in-pharmaceutical-and-life-science-companies |title=Complying with US Food and Drug Administration(FDA) data regulations is proving a struggle for IT departments in pharmaceutical and life science companies |publisher=Storage Networking Solutions |date=17 November 2004 |accessdate=06 April 2013}}</ref>
 
The FDA had indicated it would produce a revised version of Part 11 by the end of 2006, after its Third Annual FDA Information Management Summit had concluded.<ref name="inPharmaFDA2006">{{cite web |url=http://www.in-pharmatechnologist.com/Regulatory-Safety/FDA-to-review-electronic-signature-regulation |title=FDA to review electronic signature regulation |author=Reymond, Emilie |publisher=in-Pharma Technologist |date=24 October 2006 |accessdate=06 April 2013}}</ref> Those revisions never arrived, and little in the way of updates on the topic arrived.<ref name="FBFDA09">{{cite web |url=http://www.fiercebiotechit.com/story/dont-sweat-part-11-stuff/2009-11-13 |title=Don't sweat the Part 11 stuff |author=Miller, George |publisher=FierceBiotechIT |date=13 November 2009 |accessdate=06 April 2013}}</ref> On July 8, 2010, the FDA announced it would begin to audit facilities working with drugs "in an effort to evaluate industry's compliance and understanding of Part 11 in light of the enforcement discretion,"<ref name="FDAAnnounceJul8">{{cite web |url=http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm204012.htm |title=FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs |publisher=U.S. FDA |date=08 July 2010 |accessdate=06 April 2013}}</ref> leaving some to wonder if this was an indicator the regulation and/or its guidance would finally see a revision.<ref name="GxPEnforce">{{cite web |url=http://gxpperspectives.com/2010/07/25/part-11-how-will-fda-enforce/ |title=Part 11: How Will FDA Enforce? |author=Barsky, Emma; Grunbaum, Len |publisher=GxP Perspectives |date=25 July 2010 |accessdate=06 April 2013}}</ref><ref name="PharmProcEnforce">{{cite web |url=http://www.pharmpro.com/blogs/2010/07/audit-alert-clarity-e-records-fda-re-evaluate-21-cfr-11 |title=Audit Alert! - Clarity on e-Records: FDA to Re-Evaluate 21 CFR 11 |author=Appel, Ken |publisher=Pharmaceutical Processing |date=28 July 2010 |accessdate=06 April 2013}}</ref>


==Further reading==
==Further reading==


* [http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&sid=5ff3a0efed913ef8fae9e225869688a2&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21 Title 21 CFR Part 11 at the U.S. Government Printing Office]
* [http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&sid=5ff3a0efed913ef8fae9e225869688a2&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21 Title 21 CFR Part 11 at the U.S. Government Printing Office]
* [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11 Title 21 CFR Part 11 at the FDA]


==References==
==References==

Revision as of 22:18, 6 April 2013

The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) provides compliance information regarding electronic records and electronic signatures. Within this part, requirements are created to help ensure security, integrity, and confidentially of electronic records and to ensure electronic signatures are as legally binding as hand-written signatures.[1]

History

By the early 1990s, food and drug manufacturers approached the U.S. Food and Drug Administration (FDA) about the possibility of electronic submissions with electronic signatures. However, at that time the government did not allow for digital signatures. In July 1992, the FDA began soliciting comments about the process of using electronic signatures.[2]

In March 1997, the FDA issued Part 11 regulations which, in the words of the FDA, were "intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health."[3] Various keynote speeches by FDA insiders early in the 21st century (in addition to compliance guides and draft guidance documents)[3] as well as strong efforts by the FDA to motivate industry to move to e-filing[4] resulted in many companies like Eli Lilly[5], Agilent Technologies[6], and other businesses rapidly being forced to change their methods and systems to adapt to the new standards.[3][7]

However, many entities expressed concerns about the Title 11 conditions, including concerns the regulations would "unnecessarily restrict" the use of technology, add significant compliance costs beyond what was intended, and stifle technological innovation while reducing public health benefit.[3] In November 2002, the FDA released the guidance document "Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records" to the public for commenting.[8] On February 3, 2003, the FDA withdrew that document, stating "we wanted to minimize industry time spent reviewing and commenting on the draft guidance when that draft guidance may no longer represent our approach under the [current good manufacturing practice] initiative," adding it would afterwards "intend to exercise enforcement discretion with regard to certain part 11 requirements."[3] Further guidance documents were withdrawn later that month, culminating in a final guidance document in August 2003 stating the government body would re-examine Part 11 and make necessary changes.[3][9] This change in policy led many IT members in the pharmaceutical and life sciences industry in late-2004 to state one of the key problems they face is the lack of clear guidelines from the FDA about what is required for compliance.[10]

The FDA had indicated it would produce a revised version of Part 11 by the end of 2006, after its Third Annual FDA Information Management Summit had concluded.[11] Those revisions never arrived, and little in the way of updates on the topic arrived.[12] On July 8, 2010, the FDA announced it would begin to audit facilities working with drugs "in an effort to evaluate industry's compliance and understanding of Part 11 in light of the enforcement discretion,"[13] leaving some to wonder if this was an indicator the regulation and/or its guidance would finally see a revision.[14][15]

Further reading

References

  1. ↑ "Electronic Code of Federal Regulations - Title 21: Food and Drugs - Part 11: Electronic Records; Electronic Signatures". U.S. Government Printing Office. http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&sid=5ff3a0efed913ef8fae9e225869688a2&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21. Retrieved 02 March 2012. 
  2. ↑ Jackson, William (1 June 2000). "FDA offers electronic option". GCN. http://gcn.com/Articles/2000/06/01/FDA-offers-electronic-option.aspx?Page=2. Retrieved 06 April 2013. 
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 "Part 11, Electronic Records; Electronic Signatures — Scope and Application". U.S. Food and Drug Administration. August 2003. http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm. Retrieved 06 April 2013. 
  4. ↑ Greenemeier, Larry (25 February 2002). "FDA Moving To E-Filing". InformationWeek. http://www.informationweek.com/fda-moving-to-e-filing/6500937. Retrieved 06 April 2013. 
  5. ↑ Greenemeier, Larry (18 February 2002). "Lilly Cures Inefficiency With IT". InformationWeek. http://www.informationweek.com/lilly-cures-inefficiency-with-it/6501017. Retrieved 06 April 2013. 
  6. ↑ "Agilent Introduces Security Pack for Analytical Laboratories". Laboratory Network. 20 June 2000. http://www.laboratorynetwork.com/doc/Agilent-Introduces-Security-Pack-for-Analytic-0001. Retrieved 06 April 2013. 
  7. ↑ Harrold, Dave (1 April 2002). "'I'm from the Government, and I'm Here to Help You!'". Control Engineering. http://www.controleng.com/single-article/i-m-from-the-government-and-i-m-here-to-help-you/61fedbc69297fc6965c6d8840871e085.html. Retrieved 06 April 2013. 
  8. ↑ "FDA releases 21 CFR Part 11 guidance document". Control Engineering. 3 January 2003. http://www.controleng.com/search/search-single-display/fda-releases-21-cfr-part-11-guidance-document/5edbb001e1.html. Retrieved 06 April 2013. 
  9. ↑ "FDA plans to amend 21 CFR Part 11 rules". in-Pharma Technologist. 5 September 2003. http://www.in-pharmatechnologist.com/Drug-Delivery/FDA-plans-to-amend-21-CFR-Part-11-rules. Retrieved 06 April 2013. 
  10. ↑ "Complying with US Food and Drug Administration(FDA) data regulations is proving a struggle for IT departments in pharmaceutical and life science companies". Storage Networking Solutions. 17 November 2004. http://snseurope.info/article/12833/Complying-with-US-Food-and-Drug-Administration(FDA)-data-regulations-is-proving-a-struggle-for-IT-departments-in-pharmaceutical-and-life-science-companies. Retrieved 06 April 2013. 
  11. ↑ Reymond, Emilie (24 October 2006). "FDA to review electronic signature regulation". in-Pharma Technologist. http://www.in-pharmatechnologist.com/Regulatory-Safety/FDA-to-review-electronic-signature-regulation. Retrieved 06 April 2013. 
  12. ↑ Miller, George (13 November 2009). "Don't sweat the Part 11 stuff". FierceBiotechIT. http://www.fiercebiotechit.com/story/dont-sweat-part-11-stuff/2009-11-13. Retrieved 06 April 2013. 
  13. ↑ "FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs". U.S. FDA. 8 July 2010. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm204012.htm. Retrieved 06 April 2013. 
  14. ↑ Barsky, Emma; Grunbaum, Len (25 July 2010). "Part 11: How Will FDA Enforce?". GxP Perspectives. http://gxpperspectives.com/2010/07/25/part-11-how-will-fda-enforce/. Retrieved 06 April 2013. 
  15. ↑ Appel, Ken (28 July 2010). "Audit Alert! - Clarity on e-Records: FDA to Re-Evaluate 21 CFR 11". Pharmaceutical Processing. http://www.pharmpro.com/blogs/2010/07/audit-alert-clarity-e-records-fda-re-evaluate-21-cfr-11. Retrieved 06 April 2013. 
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