Inspection Readiness: Tips for Handling Original Documents and Tracking Transfers

A comprehensive readiness plan for an FDA inspection includes thorough knowledge of your document archiving and transfer procedures, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18.

Walking attendees through his list of 10 questions to consider when preparing for an FDA inspection, David L. Chesney, principal of DL Chesney Consulting, spoke about the problem of having multiple originals. Make sure written procedures define versions, such as draft, final and original, he said, adding that final versions should be reconciled with originals and any removals need to be documented.

Another question for inspection readiness is whether or not manufacturers have written requirements for in-house, remote or contracted employees and third-party vendors to transfer materials into the archives.

For example, in the case of a remote employee who keeps training records at home and transfers them to the central office, there should be a transfer procedure that outlines the timeframe and method of documenting the transfer.