Many Thanks to John Boettcher of Searle/Monsanto for initiating this great resource !!
21 CFR Part 11 Working Group Resource Center
In March 1997, CENSA established the first Pharmaceutical Industry Working Group to provide guidance to industry and the FDA about the potential impact of the FDA's Rule, 21 CFR Part 11: Electronic Signatures; Electronic Records. The rule became law in August 1997.
Purpose of 21 CFR Part 11 Resource Center:
This web page is a resource to direct interested parties to information about the Food and Drug Administration's 21 CFR Part 11 Rule on Electronic Records and Electronic Signatures. We hope it will assist any and all who wish to learn more about the FDA's rule.
Feedback or Additional Links??
Please send comments, suggestions or information about other Web resources
on 21 CFR Part 11 to
Many Thanks to John Boettcher of Searle/Monsanto for initiating this great
resource !!
Documents Available from the Government
Electronic Records; Electronic Signatures (21 CFR Part 11) links to an FDA web page that contains documents produced by the agency over the time that the rule evolved. One of the documents is the rule itself, which became effective on August 20, 1997.
General Principles of Software Validation is a draft guidance for industry published by the Center for Devices and Radiological Health in June, 1997.
Computerized Systems Used in Clinical Trials is a draft guidance for industry published in June, 1997, and includes discussion of requirements for use of electronic records and electronic signatures with clinical computer systems.
Guidance for Industry Providing Regulatory Submissions in Electronic Format - General Considerations, a guidance document that discusses general issues common to all electronic regulatory submissions, was published in January, 1999.
Guidance for Industry Providing Regulatory Submissions in Electronic Format - NDAs is a guidance document that "represents CDER's current thinking on providing regulatory submissions in electronic format." A draft was published in April, 1998. In July, 1998, PhRMA issued a response to the FDA on the guidance. The final version was published in January, 1999.
Draft Guidance for Industry: Electronic Submissions of Case Report Forms (CRFs), Case Report Tabulations (CRTs) and Data to the Center for Biologics Evaluation and Research is a guidance document issued by CBER in May, 1998. The draft goes into detail how the Center would like to see CRFs, CRTs and data electronically submitted.
Security and Electronic Signature Standards; Proposed Rule (45 CFR Part 142) is a Health and Human Services proposal for standards around security of individual health records and use of electronic signatures by health plans and providers. Thanks to Tam Woodrum for passing this URL along.
Docket 92S-0251 - Electronic Submissions is an electronic docket established by FDA to list the types of submissions that are acceptable in electronic form.
The Current Codified CGMP Regulations, 21 CFR Parts 210 and 211 are the GMP's, which can be very handy to search for specific types of information in the regulation.
Good Laboratory Practice for Nonclinical Laboratory Studies, 21 CFR Part 58 are the GLP's.
Current Good Manufacturing Practice (CGMP) Final Rule, 21 CFR Parts 808, 812 and 820; Quality System Regulation for Medical Devices are updated regulations with emphasis on added design controls and quality systems. Thanks to Karen Raskasky and Steve Haag for suggesting this information be included as a resource.
Human Drug CGMP Notes are published quarterly within FDA to distribute information about issues on human use pharmaceuticals manufacturing practices. It includes a section at the end called "Toward the Electronic Government", which often features issues around the ESig Rule.
Information from Meetings, Presentations and Publications
Follow Up to the Proposed E-Sig Rule is a presentation Paul Motise made in February, 1997, that describes feedback received on the proposed rule.
SQA CVIC Meeting 06/10/97 contains notes of a Society of Quality Assurance sub-committee meeting with Paul Motise from FDA in attendance. At the meeting, Paul Motise answered almost 40 questions submitted to him about the new rule. The notes were taken and made available to the public by Karen Raskasky.
The Electronic John Hancock by Helen Gillespie was published in October, 1997, and is a high level description of how the rule fits into LIMS operations.
SQA CVIC Meeting 12/10/97 contains notes of a Society of Quality Assurance sub-committee meeting with Charles Snipes, Stan Woollen and David Lepay from FDA in attendance. The notes were taken and made available to the public by Karen Raskasky.
Drug Information Association- Information Technology Initiatives in Drug Registration Submissions - January 12-14, 1998 includes presentations by Paul Motise - Highlights and Interpretation of the Regulation, Stan Woollen - Guidance for Use of Electronic Records in Clinical Trials, and Steve Kopco - Electronic Records/Signatures: Final Rule. The last of the three was to present an industry perspective of the rule.
Guidance for Industry: Submissions in Electronic Format, April 30, 1998, had CDER representatives from the Office of Information Technology and the Electronic Submissions Technical Working Group provide an overview of draft guidance documents. In addition, they presented an example of a full electronic submission, described CDER's procedures for processing these electronic submissions, and discussed lessons learned from electronic submissions received since September, 1997.
Computerized Systems Used in Clinical Trials was presented at the June, 1998, DIA Annual Meeting. CDER AERS Electronic Submissions Pilot, which discusses electronic submission of adverse events, was presented at the same session.
At a day-long tutorial held in September, 1998, participants were asked to anonymously answer "Yes" or "No" to statements describing their company response to 21 CFR Part 11. Thanks to Jim Bradburn for allowing the results of the survey to be shared.
Digital Signatures for Electronic Tax Forms to be Tested, August 27, 1998, is a short article explaining how the IRS plans to use digital signatures in a pilot designed to test technology that eliminates the need for signed, hard-copy tax returns to be filed.
A threaded discussion from January, 1998, about use of paper vs. electronic media for recording Raw Data captures the main points Paul Motise makes on this issue, along with some opposing views. Click on the 'Next in Thread' links to follow further exchanges on the subject.
Have you ever had the feeling that you are the only one who didn't understand how digital signatures work? Well, that makes at least two of us. The American Bar Association has on online Tutorial explaining digital signature technology. The full ABA Digital Signature Guideline is also available.
Technology Information Service Digital Signature Links supplies a series of links that present information how digital signatures are being used in the courts. They also maintain links for Electronic Filings of court documents, which provide sources about electronic record keeping efforts in the legal system.
The Chicago law firm of McBride, Baker & Coles maintains an extensive listing of digital signature and electronic commerce legislative sites. It includes links for summaries of initiatives for all fifty states, national initiatives and international efforts.
CENSA is the Collaborative Electronic Notebook Systems Association. It is an international industry association, focused on driving the state of the art for electronic recordkeeping systems and collaborative technologies wherever they are used, with an emphasis on industry and government agency needs. Their website has a section called CENSA Weblinks, which leads to many other sites that are focused on technologies that are relevant in light of the FDA's rule.
Guidelines on Best practices for Using Electronic Information resulted from work done by the European Union and European Commission. It provides some useful information on managing electronically stored data. The PDF version of the guideline is available to the public.
The Preservation of the Integrity of Electronic Records is a research project at the University of British Columbia which is aimed at identifying and defining the requirements for managing electronic records. They have been successfully collaborating with the Department of Defense for several years, and the DoD has started using UBC concepts in development of their electronic record keeping systems. The Department of Defense Records Management website has additional information, including DoD 5015.2-STD, Design Criteria Standard for Electronic Records Management Software Applications. (Note: The last two sites referenced above were temporarily unavailable while the US Department of Defense reviewed information made available to the public over the internet. See Deputy Secretary Hamre Orders Review of Web Security for details.)
For the Record: Protecting Electronic Health Information (1997), is a 288 page report from the Committee on Maintaining Privacy and Security in Health Care Applications of the National Information Infrastructure, sponsored as part of the National Academy of Sciences/National Research Council. It includes several chapters on maintaining security and privacy of electronic health information.
The German Digital Signature Law, or Article 3 of the Information and Communication Services Act, provides the conditions for a secure infrastructure for the use of digital signatures in Germany. It was enacted on July 13, 1997, and promotes conditions assuring that manipulation of signed data can be reliably ascertained.
The Indiana University Electronic Records Project has established a page with links to other electronic records projects. It leads to many good sources on the subject for anyone who wants to know more.
Cohasset Associates, Inc., is a consulting firm that specializes in the management of hardcopy and electronic records. Once again, their web site is an excellent starting point for running down information on electronic record keeping.
TBD
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Changes last made on: 09/09/01 10:53:14 AM