Computer System Validation (CFR 21 Part 11) Lesson-3

CFR 21 Part 11 :-

The rule has two main areas of enforcement: electronic records and electronic signatures. The rule applies to all areas of Title 21 of the Code of Federal Regulation (CFR) for all manufactured drugs and medical products distributed in the United States of America.

It must be noted that using Electronic record keeping and electronic signature are not mandatory, but if used must comply with the regulations in 21 CFR part 11.

Electronic records: - It must be possible for electronic records to be printed in a readable format. For batch release related records, it should be possible to generate and print out the changes made to the original data.

Electronic signatures: - Electronic signatures should be unique to one individual and there must be procedures to ensure that the owners of the electronic signatures are aware of their responsibilities for their actions, i.e. Users must be aware that electronic signatures have the same impact as hand-written signatures. Electronic signatures must be permanently linked to their respective electronic records to ensure that the signatures cannot be edited, duplicated or removed in anyway.

·         Electronic signatures must clearly indicate:

·         The displayed/printed name of the signer

·         The date and time when the signature was executed; and

·         The reason for signing (such as review, approval, responsibility, or

·         Authorship) associated with the signature.

·         21: Short for “Title 21,” which is the section of the CFR that applies to food and drugs. The CFR contains 50 “titles.”

·         CFR: Short for “Code of Federal Regulations,” which is a set of laws published by the federal government of the United States?

·         Part 11: This part of Title 21 is specific to electronic records and electronic signatures, which includes electronic submissions to the FDA.

History of CFR 21 Part -11

Ø Year -1990 :-  Eliminate Paper Based Record and Focus with Electronic Record and Signature.

Ø Year 1991 :-  FDA Appointed Task Force on Electronic Identification/Signature and Formulate Paperless Guide LINE.

Ø Year 1992 :- (February) US FDA Introduced to the Public. Working Group Recommended Publication of an Advance notice (ANPRM) to obtain Public Comment.

Ø Year 1994 :- FDA Published the Propose rules in the Federal Register and 49 Comments.

Ø Year 1997 :- March 1997 FDA Published CFR 21 Part 11 final Rule

20 Aug 1997 Rule Effective .

  Ø  Year 1999:-  FDA Publishes Compliance Policy Guide Line five Guidance Document

  Ø  Year 2002:- FDA Announces Modernization initiative, Pharmaceutical cGMPs for the 21^st Century – A Risk Based Approach

  Ø  Year 2003 :-  The FDA Revoked CPG 7153.17 .FDA Published New Guideline for Industries  Part-11 Electronic Signature and Electronic Signature (Scope and Application).

  Ø  Year 2007 :-  in may 2007, the FDA Issued the final Version of the Guidance on Computerized System in Clinical Investigations (CSUCT)

  Ø  YEAR 2010 :-  FDA Announce intent to Conduct Inspection Focusing on CFR 21 PART-11 Requirement Related to Human Drug.

  Ø  Year 2011:-  FDA Published an Updated Version of EU Annexure -11 (Global)

  Ø  Year 2016 :- FDA Published a Draft Guideline of Data Integrity and Compliance With cGMP Guidance.

Requirements Of Part 11

*Use of operational checks.

*User-independent computer generated time-stamped audit trails.

*Use of validated existing and new computerized systems.

*Secure retention of electronic records and instant retrieval.

*System and data security, data integrity and confidentiality through limited authorized access to systems and records.

*Use of secure electronic signatures for closed and open systems

*Use of device checks.

*Use of digital signatures for open systems.

*The determination that the persons who develop, maintain or use electronic systems have the education, training, and experience to perform their assigned task

*Electronic submissions to the FDA

*Improve productivity and efficiency through automation

*Restricted the use of technology

Note :- This is Only Knowledge Purpose and Blog Contain is my View  + Internet Search and Guideline.