Supplier Certificates of Conformity: Are They Sufficient?

Q: Is it acceptable to use supplier Certificates of Conformity sent with their products as evidence they were manufactured per specifications? I’m getting questions about products supplied by our OEMs and contract manufacturers. This has been our approach in the past,…

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Auditing Computer Systems: Some Quick Tips

Here are some quick tips for auditing computer systems. Choose a function within the system to audit. Select the function based on: A known point of risk; A known problem or defect; Complaints, break/fix records, system change records, data change…

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Is FDA OK with General or Shared Passwords?

Q: I’m reviewing our policy on shared passwords and accounts. We’ve issued a limited number of general passwords to supervisors or operators on the production floor so they can retrieve production documents electronically. Under 21 CFR Part 11.300(a), is it…

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