FDA to Review Electronic Signature Regulation
The Third annual FDA Information Management conference is coming up next month and it will be interesting to see what comes out of it. For a long time 210 CFR Part !! has been controversial and created a lot of confusion and talk concerning implementation and exactly what was required.
FDA to review electronic signature regulation
I remember when these regulation came out and the amount of confusion it caused. Also, many companies were hesitant or refused to go with an electronic system mainly because at the time, none of the commercial software for analytical instruments had the capability to track users and lacked password protection. The main problem was that the regulations were requiring systems that involved many parties and not just the pharmaceutical manufacturers. It wasn’t until the systems software developers were broung into the fol and it explained what was desired and
As the technical person responsible for choosing a contract manufacturer back in the lately 1990’s and early 2000’s, I remember touring contract manufacturers’ analytical labs and one of the first things I always tried was to see if the computers connected to the instruments had password protection. Sadly, many did not and allowed access to the system for anyone who stepped up to them.
The requirements also set up the situation where companies preferred older paper systems and did not investment in modern technology mainly because of fears and misunderstandings of what was required. The result was the law of unintended consequences; the policy for supposedly encouraging adoption of electronic systems actually had the opposite effect.
This is a topic I’ve kept an eye on for years and find fascinating as to how the pendulum has swung in this regard from overly harsh and almost draconian to a more adaptive system. It will be interesting to see what the consensus is after this meeting.
Technorati Tags: CFR part 11, FDA, electronic signature
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