Hello Anon,
With more and more documents being electronic, this is a method some investigators are asking for documents to take instead of the hard copy. As an example I experienced quite often during foreign inspections, instead of the investigator asking to ship a box (or two!) back to their address of all the documents taken, easier with a USB stick.
The advice is make sure documents provided on the USB are properly marked and labelled as confidential and proprietary, just like you would a hard copy of the same document. The best is to watermark a PDF version and make the PDF version non-editable. Recommend not putting passwords on everything, because they do not like that having to unlock everything, every time. However, like a hard copy, the electronic version should be made in a manner which would be reflective of your documentation practices and releasing documents to an external entity like the US FDA.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 26-Jul-2023 14:25
From: Kevin Randall
Subject: FDA Inspection - USB for Copies??
FDA's access to, and collection of, evidence in electronic format can get complicated by FDA's Part 11 requirements combined with FDA's general IT security needs. But in a nutshell, yes, FDA's standard operating procedures for inspections do allow collection of evidence on a USB drive within certain parameters. In practice, that will usually be to facilitate the inspector's review of the data. But the official copies taken for the record are typically taken in hard copy format when the firm doesn't keep required records in electronic form instead of paper.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 26-Jul-2023 11:55
From: Anonymous Member
Subject: FDA Inspection - USB for Copies??
This message was posted by a user wishing to remain anonymous
Good morning! Quick question for those of you experienced in FDA inspections of the medical device company... is it common for the FDA inspector to request a USB drive with copies of documentation? This is our first audit.