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

Internal Audit Report: Can FDA Request Yours?

Q: Does FDA have the legal right to request an internal audit report or an annual product review report? I’ve heard that in most cases FDA won’t request those kind of reports, but instead may ask to review our Standard Operating…

Share

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,…

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