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…

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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…

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