Webinar: Best practices for validating literature monitoring searches

Webinar registrationIn the context of literature monitoring for adverse reactions to medicinal products (EMA GVP Module VI), a reasonable number of Market Authorization Holders have no ready answer to justify why they use each search formula for each specific product when Audit or Inspection time comes: in fact the search formula, responsible for all the inbound traffic in the Literature Monitoring process is, many times, not validated, or regularly reviewed. How does one create a “good” PV search formula for Literature Monitoring and validate it? By “good” we understand: a formula where you can justify, to an auditor or inspector, why do you use it instead of any other -one-.

In this webinar, I will discuss the process of (re-)validation of the search formulas used for literature monitoring in the context of EMA’s GVP Module VI. This will enable you to create and fine tune the search formula and, when needed, present evidence, to an auditor or inspector, on each search formula fitness for purpose.

Please register at https://attendee.gotowebinar.com/register/7681457997368414209

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.