Validation

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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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…

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Download an EduQuest Advisory on Your Kindle

An EduQuest Advisory for two FDA compliance challenges are now available for immediate download on KindleTM readers (and Kindle apps on Ipads and other mobile devices). An EduQuest Advisory is a brief but comprehensive white paper that provides practical FDA compliance advice from…

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