If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of your competitors at FDA-regulated firms, industry consultants and even FDA agents.“Any electronic record system that can’t comply today should not be in service,” states John McKenney, SEC Associates’ president and CEO. While speaking at a Drug Industry Association event in 2004, he stressed that with the exception of open and electronic signature systems, the controls required today by the FDA for Part 11 aren’t significantly different from the agency’s expectations for validated computer systems dating back to the late 1980s.

The cost-benefits of Part 11 compliance are difficult to break out as a separate line item on the budget, but the fact that they save companies time and money is self-evident. “I firmly believe that [Part 11’s] validation and data integrity controls are good business practices,” states Keith Benze from SEC Associates.

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