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World of Compliance Module

Several types of records need to be kept - standard operating procedures (SOPs), process validation, equipment qualification and computer system validation (protocol and executed protocol).

SOPs provide information for completing the task and the associated documentation. There is a document that explains the cleaning procedure and then another document that puts together when the cleaning was done and who did it. The associated documentation for each of these standard operating procedures makes up the bulk of the record review during the inspection process.

Man working on computerComputers are becoming more and more integrated into the manufacturing process making computer system validation more relevant. Because most FDA inspectors or investigators don't have direct backgrounds in computer science or programming, there is a challenge for inspectors to learn how a company validated a program.

Going through the operational qualification makes sure that pushing a button actuates some event(s). If that works, then the inspector can assume that as long as equipment or the computer is plugged in, it should work accordingly. That's how computer validation is supposed to work.

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Topic: page 3 of 3 (Lesson: page 20 of 35)