Tag Archive for Martin Browning

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…


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…