CONTROL OR MESS: WHERE’S MY DOCUMENT?

You are sitting in a room with an auditor who asks for the files about a customer complaint and CAPA associated with a production run and wants to see all design and device master records and the associated SOPs for the production and the CAPA. You send a message to your team to find all the pertinent paper files and bring them to you, while you ask the auditor to wait. Your team searches for the documents and finds some of the manufacturing SOPs in a filing cabinet but only an old copy of CAPA handling procedure. The team continues to struggle not knowing where the author has placed the final released version, as they have since left the company. You have the device history record (DHR) but it references several SOPs for the production process and the original product specifications from the design transfer but not the latest changes. Unfortunately, the SOP revision number doesn’t reflect what’s in your manufacturing folder and the files don’t show that the manufacturing operators were trained on the latest documents. No change record was found to provide evidence of the revision. The team ends up finding the Design History File for the product from R&D engineer who had it on his desk but doesn’t find the associated Design Master Record for the changes that occurred to the product and Labeling specifications. After several frustrating days, the auditor summarizes several key violations resulting in an adulterated product. You expect to receive a Warning Letter and the need to start the recall process for those product lots.This is just one example where too much dependence on physical documents can put you on the regulatory agency radar, impact your brand and cost you money. If you have gone through a similar scenario, you have, no doubt, wondered that this fiasco could have been avoided if only there was an easy to find your critical documents at a short notice. Fortunately, there is a way, but first let’s take a look at typical challenges associated with Physical document management!
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