Part 11: What can I ask people about now?
The official title of 21 CFR Part 11 is “Electronic records; electronic signatures.
For some reason, it is generally referred to as Part 11 rather than the official name.
Part 11 began in the early 1990s when industry asked the FDA to specify rules regarding electronic signatures.
Until then, pharmaceutical companies had to eventually print all records for the reason that they had to sign (by hand), even though they came in electronic form.
This is unreasonable, which is why there is a growing awareness of the need for electronic signatures, i.e., paperless.
In response to this request, the FDA provided advance notice of the proposed regulation in the Federal Register (FR), presented its views and concepts as the FDA, and held repeated discussions with the industry.
As a result, the 21 CFR Part 11 Electronic Records and Electronic Signatures Draft Rule (proposed regulation) was published on August 31, 1994.
Public comments were solicited and 49 comments were submitted by the industry.
All of them were deep in content and raised many issues that could not be easily resolved.
FDA published a final rule, The final rule on electronic records, signatures, and submissions, which lightened the burden to comply in response to comments, in the FR on March 20, 1997, and became effective on August 20, 1997.
Part 11 was the world’s first regulatory requirement for paperless
In fact, in the course of FDA’s repeated discussions with the industry, the agency realized that electronic signatures (Electronic Signature) would be the main focus at first, but that electronic records (Electronic Record) were important.
Printing on paper exempts you from Part 11!
In the course of my consultations, I have seen many companies that have a policy of “printing records on paper and hand-signing them as “correct” because they are afraid of violating Part 11″ (i.e., all records are printed on paper and hand-signed (stamped)). (i.e., all records are printed on paper and hand-signed (stamped). However, this is not the case. However, such a tactic will not exempt them from Part 11.
This is because Part 11 applies from the point in time when electronic records and electronic signatures are used in the process of creating such records, even if the final form is paper.
This is also true for the ER/ES guidelines in Japan.
Systems to be shown at FDA inspections must be Part 11 compliant!
A well-known consultant in the industry said, “All systems to be shown to inspectors at FDA inspections must be Part 11 compliant! I heard that he said.
For example, it could be a document management system or cloud system (such as BOX) that manages SOPs.
However, it is believed that the consultant has never witnessed an FDA inspection.
I have been attending FDA inspections for more than 20 years and have never been asked by FDA inspectors about CSV or Part 11 compliance of document management systems.
Because their Part 11 compliance has absolutely no impact on patient safety or product quality.
The U.S. is a country that values fairness, so if we ordered one company to comply with Part 11 of the document management system, we would have to provide similar guidance to companies around the world.
I would like you to consider this. What would happen if guidance was given that had little or no impact on patient safety or product quality, but only unnecessarily imposed compliance costs?
As a result, the cost is passed on to the drug price, which is borne by the patient.
FDA inspectors are not here to investigate your computer system. We should not take seriously the self-righteous talk of consultants who only encourage such fears.
There is no such thing as a Part 11 inspection in the first place!
FDA conducts GxP inspections, not Part 11 inspections. There is no such thing as a Part 11 inspection; the FDA has no Part 11 checklist and no Part 11 inspection guide.
Currently, however, data integrity inspections based on Part 11 are conducted only for quality control (QC) and shipment approval processes for human pharmaceutical products. This is because they have a significant impact on patient safety.
At least in medical device companies, Part 11 inspections are unlikely. Pharmaceutical companies also do not need to worry about Part 11 inspections except for those mentioned above.
However, there is something you should understand well.
Part 11 is a regulatory requirement for electronic records. It is still in effect.
However, it is not only the reliability of electronic records that is important, but also the reliability of paper records.
Therefore, data integrity inspections are now conducted instead of Part 11.
This is because the impact on the patient is the same for both falsification of electronic records and falsification of paper records.
In other words, Part 11 is out of date; consultants from IT firms are obsessed with electronic records, but data integrity should be fully considered, including paper records.
When I listen to presentations on data integrity measures by pharmaceutical companies, they only give consideration to the security of electronic records. This is not sufficient.
The falsification of records, including paper records, must also be prevented from non-malicious human error.
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