Dyfrig Wilson

Singapore

IT

I've been in the Pharmaceutical IT business for 10 years and it surprises me that the FDA would recommend a specific technology as a solution to a problem.

Typically through their history the FDA issues guidelines and regulations (enforceable laws) when problems arise with Pharma products.

In 1997 the FDA issued 21 CFR Part 11 - the regulations governing e-Records and e-Signatures. This was in response to the industry that had requested rules governing the use of electronic records in lieu of paper records. Part 11 has undergone a number of changes since then.

However, at no time has the FDA recommended any technology, as their philosophy was that the industry knows best how to solve their problems, the FDA just provides the rules.