Don't sweat the Part 11 stuff

While 21 CFR Part 11 guidelines on electronic records and electronic signatures remain under review with the ultimate goal of revision, consider the ISPE's GAMP guidance a source of support. GAMP 5 offers a "practical approach to compliance in the meantime," says Sion Wyn of the UK-based IT consultancy Conformity, who has assisted the FDA Part 11 guidance development efforts.

During last week's ISPE annual meeting, Wyn conducted a Part 11 myth-busting exercise. Among the myths: Providing copies of records to FDA requires extreme measures.

"You need to provide reasonable and useful access to records during an inspection," he says. If inspectors ask for records in portable format (e.g., PDF), and you have them that way, provide them. If your records exist in a more proprietary format, you can use established automated conversion or export methods to make copies in a common format.

All records held by you are subject to inspection, says Wyn. And if you have the ability to sort, search or show trends in Part 11 records, the copies you give to the FDA should provide the same capabilities.

But "reasonableness" cuts both ways, he says. "It's not open season on your records. You don't have to say to the inspector, ‘Here's my password....' Just do something sensible. Clarity of thinking is the key."

- the GAMP 5 document is available for sale here
- here's an ISPE intro to GAMP 5 podcast