Part 11 History and Trends

Teil 11 History and Trends

21 CFR Part 11 (“Part 11”), at the request of the U.S. pharmaceutical industry to achieve paperless “Electronic Signatures” at the request of the U.S. pharmaceutical industry to make paperless a reality.
Since Part 11 was published on March 20, 1997, it has never Not revised.
However, in the ever-evolving world of computers, rules created 25 years ago are not valid today.
Once Part 11 was operational, it was initially Electronic signatures were the focus, but it was recognized that electronic records were more important.
After Part 11 went into effect, new findings regarding electronic records and electronic signatures were discovered, and FDA has changed its expectations and guidance by operation without revising Part 11 Since Part 11 has not been revised, the latest FDA expectations and guidance are not described.
Because of the difficulty of interpreting the text of Part 11 and complying with the requirements (especially compliance costs), industry has repeatedly requested that FDA withdraw (relax) Part 11.
Fearful of the Part 11 point, Currently, the FDA is not interested in electronic or paper records, but Data Integrity.

Scope and Application

FDA advocated taking a risk-based approach when it issued its Scope and Application in September 2003.
The FDA is also sensitive to the rising cost of healthcare.
The risk-based approach must focus on patient safety, efficacy, and product quality.
Part 11 is strictly applied to raw data. Documents need to be managed differently. If documents are created with malicious intent, no amount of security or audit trails can prevent fraud.
It is important to note that Part 11 and Scope and Application are still in effect.
Many companies are concerned about noncompliance with Part 11 and assume that the paper version is “correct”, but this is not the case. Part 11 applies from the time the electronic record is created, even if the final format is paper.
No Part 11-based warning letters have been issued since 2001. To begin with, “Part 11 inspection” There is no such thing.
Since 2010, Inspection (investigation) on Part 11 has resumed, but only for human drugs. The purpose is to monitor OOS (Out of Specification). This is because falsification of records, whether intentional or accidental, poses a problem for patient safety.


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