Happy 25th Birthday 21 CFR 11 !
March 20th 1997 – March 20th 2022
Happy 25th Birthday 21 CFR 11
25 years ago, after about 7+ years of work, US-FDA released 21 CFR 11.
This rule, about use and handling of electronic records and electronic signatures within the regulated environments staying under FDA oversight, should have introduced the healthcare sector in the 21st Century: less (no) paper, more (only) electronic records signed electronically.
Already at this time, 21 CFR 11 did not stand alone. European Annex 11 – Computerised Systems – was released in 1992 for defining the requirements applicable to computerised systems supporting GMP activities.
Instead of seizing the opportunity offered by regulation to make a smooth transition to a digital working environment, the pharmaceutical industry preferred to continue working paper-based.
This behaviour is difficult to understand, since it was the pharmaceutical industry who initially asked in the late 1980s for being able to use “modern” media for communicating with the agencies instead of having to supply mountains of paper to the authorities.
We are 25 years after 21 CFR 11 release and the pharmaceutical industry remains the “hidden paper factory” [1], making every process heavy and boring for the involved people as well as error prone.
In May 2020, I subtitled a webinar proposed by GAMP Francophone about electronic documents and electronic signature with the mention “What 21 CFR 11 couldn’t achieve in 23 years, Covid-19 does it in 6 weeks”.
Beside some sarcasm, this claim was definitively too optimistic. Even 2 years after the beginning of the pandemic, the pharmaceutical industry still mostly sticks on paper, even if some improvements could be noticed.?Instead of being able to work remotely with ease as their processes are electronic without a problem, some companies are mailing paper records for signing to people’s houses.?
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Dear managers of pharmaceutical companies,
would you like to travel with airlines who can’t meet ?25 year old regulations?
If not, why don't you support compliance adequately within your organisation?
Compliant process digitalisation is not painful and expensive; it will make your organisation better, more efficient, and finally more compliant.
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Dear equipment and software suppliers,
I can understand that you are happy to make business with (and to earn money from) the pharmaceutical industry. However, a lot of you totally ignore the regulatory requirements your customers have to fulfil; or you are not motivated to consistently implement those requirements in your equipment and solution.
Your usual excuse for poor compliance support is that the pharmaceutical market is too small comparing to the other markets you supply.
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Could you imagine, that the editor of an accounting software could say: “dear customer, since you live in a small country, our solution is not able to support the applicable local accounting rules, we only focus on the big countries!” ?
Beside the fact that the tax administration would not agree with such a statement, I would like to remind you that the pharmaceutical sector is not as small. Otherwise, if the business with regulated customers is so “negligible” for your overall turnover, why don't you provide your service “for free”, since you should not notice the difference at year end?
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Annex 11, since 30 years, and 21 CFR 11, since 25 years, offer to the pharmaceutical industry a lot of space for becoming better and more efficient, for achieving compliance in a smooth and reliable way.
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Dear pharmaceutical industry, instead of complaining, take this opportunity to digitalise your processes!
Dear suppliers, you should understand that your compliance laziness significantly jeopardizes the position of your customers in front of the authorities.
?Don't forget, regulatory compliance first and ultimate objectives are patient's safety!
One day, each of us could / will become a patient.
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Happy birthday 21 CFR 11, happy birthday Annex 11!
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Special thanks to:
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[1] R.D. McDowall, LCGC Europe August 2021 (326-330) “The Hidden Factory in Your Laboratory?”
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