Tag Archive for documentation

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…

Share

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…

Share

Archiving Training Records

Q: Can you tell me how long I should keep training records and when to archive them? We manufacture active pharmaceutical ingredients (APIs) with an expiration date of five years. A: The rule of thumb is to keep training records…

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