Stupid questions in job interviews (1 of many)

The question: “Where do you see yourself in 5 years? ” does not make any sense.

I hope your offer is interesting enough so that my job description, 5 years from now,  will include several tasks and competencies that do not even exist today.

And that is where I see myself in 5 years, in your company: Doing something that CAN’T BE DESCRIBED TODAY!

I am pretty sure, it will take less than two years anyway for the “never saw that coming” to emerge in the performance indicators.

 

 

 

 

21 CFR 11 Reflections: 10(a,c,d)

When I read regulatory documents I always try to imagine what possible reason can there be for someone to write a regulation and what may have been the real world case(s) that will be prevented by that text.

Sometimes it is clear that a text not only is intended to have specific consequences, but also is based on real historic situations that went bad for the community… because the regulation was not in place. Anybody with more than 5 years in programming and system management can clearly see the root cause for almost each and every item in 21 CFR 11 .

For Example:

21 CFR 11.10(a): Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

This imposition must derive from situations where the regulated company said that the “software” was bought as it was, in full confidence that the sellers promises of quality and fulfillment of the regulatory requirements, were true.

Many times the promises may even have been made in good faith but if an audit shows that the software product does not fill the requirements, does not impede irregular situations, etc… then the regulated company is at fault of not doing due diligence during the procurement process.

21 CFR 11.10(A) requires that regulated companies perform due diligence when contracting a piece of software for purposes that are regulated. And the due diligence, albeit Validation can mean many different things, simply means that the regulated company should draw a set of requirements and that it should verify and document that the contracted software fulfills the requirements.

Most of the FDA documents regarding Electronic records are just codified common sense, like: “[…] we believe it would not be prudent to store both primary and backup electronic records
on the same computer hard drive because both could be lost if the hard drive fails.” Draft of  “Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures; Maintenance of Electronic Records”

Does this mean that “Backups must not reside on the same Infrastructure as the original backed up data” should go into the Requirement Specification? Yes. As a requirement of 21 CFR 11?  If that is the way to get the requirement in there. But it should be in the specification because it is common sense.

 

New year, new life…

After a very hard year came evaluation season, and it was positive … in fact very positive …

The bosses clearly thought I was ready for new challenges. They have changed my job and I am now what I never thought I would become: a consultant. And a consultant who instead of having only customers in EMEA, is now responding to customers worldwide.

Interesting, too, that in the new roles I have, once again, to learn a lot of new things. This time around its the Code of Federal Regulations Ttitle 21, Chapter 11, EUudraLex Volume 4 Annex 11 and also PIC/S GMP GUIDE Annex 11. This more or less shows what I am doing, although it make no sense (at first glance) for a publisher editor of scientific journals and books.

Plus, all I learned last year about GAMP, is to be certified this year.

Regardless of the work ahead it is good to see that if it is recognized.

 

Primeira avaliação…

Ano novo, vida nova, etc, etc, mas  o que me faz mesmo arrancar hoje é o resultado positivo da minha primeira avaliação na empresa, hoje de tarde…

Um balanço de seis meses de aprendizagem e aferição da produtividade… com saldo positivo… e com o qual vieram também novas responsabilidades, objectivos e desafios.

אל על