Records - Do's and don't' of record entries (FDA - 21 CFR 820)

We've had a lot of the discussions that you mentioned and I agree that our system is more problematic than the GDPs themselves. I don't want to go into too much detail, but a large part of the problem stems from an unvalidated, "home-grown" inventory tracking system used by all of the company's facilities. Our facility is the only one registered to ISO13485 and registered with the FDA, so we've had to document all of our inventory pulls and returns for each run with hand-written logs since the inventory tracking system would basically be useless in an FDA inspection. Our location has recently had more positive feedback from our company's IT group in possibly validating the software, but until those validation activities are completed, we are stuck with these burdensome logs.

I'm certainly not looking for an excuse to stop using GDPs, but I was hoping maybe someone had some more definitive resources about GDP specific to medical devices. Ultimately, it sounds like my best option is pushing to turn our attention to validation of the inventory system, which truly would be a greater benefit to our company in the long run. Hopefully management will understand that while GDPs aren't hard-lined into medical device standards they are still value added to our processes.

It sounds like your inventory logs might be recording more information than needed. You need to ask yourself how these inventory sheets could affect the quality of the medical device. The company I work for has simple inventory sheets and nobody seems to think they are burdensome. No auditor is going to spend much time on your inventory sheets. They would rather focus on your inventory status labels, storage locations, and method of traceability.

The countersound might be it isn't about ensuring quality in a direct manner, but preventing loss of traceability, mixups and assigning appropriate quality status of components/tools.
If you want to deal with those in an (semi-)automated electronic system it probably meets the criteria to require validation.
If you don't want that, then commonly companies turn to 'paper/human' locks, as paper doesn't require validation. However, that imposes the burden on and risks of paper and humans.
Besides that, the FDA cares about the main system used to perform activities. If you generate all kinds of paper to pay lip-service to the requirement - but then don't use the paper records when you're doing the checks/reviews but rely on what the system can put out (which is likely if other sites do it and you are only awaiting validation) - you did a lot of effort while not being foolproof against a finding anyway.

Even if you go bare bones to the part number and lot number and recording the associated checks, for a big Bill of Materials or substantial tool set that's quite a lot of ink to write, and it might not be much less to print. If you're also returning it complexity and ink increases even more.
Good Documentation Practices are aligned with ensuring data fidelity and the bit you only feel you needed when you're looking back and need to rely on the relatives who and whens, or the why's after people have gone or forgotten.

If you need more convincing material than the fear of the FDA, then ask for a dry-run of a field safety corrective action, allowing you to compare 3 scenarios:
1) Run it with the automated system that's capable but unvalidated, and time & record its costs (+ added annual normalized costs of validation (not one-off!)).
2) Then run it as you're supposed to do it according to the paper records that you've promised to the FDA, and record time and the associated costs. Multiply the paper one times all the corrective actions people found excuses for to not do (mislabeled/adulterations ; stretchy acceptable risk ; oopsie inconclusive/forgotten/dead-end assessments).
3) Contrast FDA fine +fix-it costs. Note incalculable reputation hit and risk of premature management team renewal due to mismanagement.

Doing things for the future is harder to convince people of then telling them to stop doing things for the benefits seen now.
(People call me cynical)

Jean_B said:

mixups and assigning appropriate quality status of components/tools.

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This is normally not done through the inventory sheets. This is normally done through labeling and segregation of inventory. Traceability can be achieved through the history record alone and you would still be compliant. Inventory sheets can provide forward traceability, so there is some benefit for recall scenarios.