The Fallacy Of The "Original Paper Record"...
Paper isn’t your “original” record anymore. 21 CFR Part 11 defines how electronic data must be trusted, validated, and compliant. Learn from expert Jackie Torfin how to ensure your systems meet FDA expectations.
It happens at least a few times a year as I interface with pharma/bio/med tech clients. We start talking about computerized system use or data integrity of records, and I invariably hear some version of:
“Our electronic data is printed out and stored as ‘original data’ so there is no computerized systems data integrity issue.”
And honestly, even though I know this is patently untrue, I can understand how we all got here. The Pharmaceutical Industry originally asked FDA for guidelines around the use of computer systems to eliminate paper records in the early 1990s – back when some of us were still saving data to floppy disks. A task force was convened, and the final rule for 21 CFR Part 11 was published in 1997.
The Purpose of 21 CFR Part 11
21 CFR Part 11 Electronic Records, Electronic Signatures (Part 11) applied to all FDA program areas and stated that the use of electronic records was not mandatory. Just that comment alone created widespread confusion.
In 1999, a Compliance Policy Guide (CPG) and five guidance documents were drafted to try to help clear the confusion, however, the consensus was that the CPG and associated guidance documents significantly increased…
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