Tag Archive for Annex 11

Hard Copy Backups: Should We Keep Them?

Q: Do we need to keep hard copy backups of documents that are housed in a validated document system? I’m looking for what’s considered best practice in today’s FDA-regulated industries. One of our concerns is that we have people at our…


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…


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…