Tag Archive for 483 Observation

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…

Share

FDA Expectations for Internal Audits

Q: What are FDA’s expectations for internal audits? For example, how frequently should we conduct internal audits? And what documents does FDA expect to see to prove we’re actually doing the audits? A: First of all, FDA expects you to…

Share