When the FDA shows up with inspection notice in hand, will you be able to produce the documents they request quickly and efficiently? Knowing where all your records are stored and what condition they are in is vital to inspection success, says one former FDA district director.
Even though “clinical trial monitoring records are sort of like ‘mini audits’,” says quality consultant and 23-year FDA veteran David Chesney, sites still are subject to FDA inspection.
Chesney offers several tips for making sure records the FDA wants to see are labeled, stored, archived and easily accessible during an inspection.
Start with a consistent naming convention that is unique but succinct. File names in electronic systems often are cut short, so document titles should be identifiable by only a few words or numeric designation. And whatever convention you use, train the staff that will retrieve documents to recognize them quickly.
Archived documents should be held in easily accessed locations or designated drives, in the case of electronic records, which also should have controls over reading, copying and printing.
Inventory documents by owner, Chesney advises, and periodically reconcile that inventory to make sure documents are present. And develop both a written retrieval plan and a written strategy for processing inspection requests. It’s helpful, he says, to create a document matrix that shows the assigned document owners for each type of record likely to be requested.
For clues on what documents the FDA is likely to request, consult the FDA’s Compliance Program 7348.810, which provides agency personnel with instructions for conducting inspections.
“The challenge,” Chesney says, “is to meet the FDA requests in a timely and complete manner.” To evaluate your ability to do that, he suggests asking the following 10 questions:
Do your archives contain everything that may be requested during an inspection?
Are file names clear (ideally self-explanatory)?
Are there written requirements for in-house, remote or contracted employees and third-party vendors to transfer materials into the archives?
Do the archives contain more than one original and, if so, how are they differentiated?
Do the archives contain draft documents and, if so, how are they differentiated from final versions?
If archiving has been contracted to a third party, does the contract allow for prompt access for the records owner?
Are records produced by other parties for your company readily accessible (for example, CROs, contractors, consultants)?
Can documents be retrieved in a prompt and effective manner?
Have the access security measures associated with the archives been tested?
Do personnel responsible for the archives have the access and resources needed to produce documents during an inspection?
Chesney recommends testing document retrieval capabilities during mock inspections and internal audits, tracking how long it takes to properly fulfill a document request and working to improve that response time.
Finally, make sure to assign and train personnel who have first-hand knowledge of the documents to explain them during an inspection.
