Case Study: Medical Manufacturer

Meeting stringent compliance standards through increased information management accuracy.

Client manufactures and markets medical devices from their headquarters in Warsaw, Indiana and more than 25 countries around the world.

  • Annual sales in the billions
  • Over 8,000 employees worldwide

The Challenge

The client is required to maintain its implant manufacturing records for the life of the patient. In addition, it is mandated by the US Food and Drug Administration to adhere to a special quality standard for these records known as 21 CFR Part 820.

With such lengthy retention requirements and stringent quality standards, the client has long understood the importance of a content system. They started keeping records on microfilm. As business grew, so did their microfilm volumes – and storage headaches. They needed a partner that could take over the conversion but maintain the same service levels and stringent quality requirements.

  • Needed to move to digital images
  • Storage needs were becoming too large to continue handling in-house
  • Weekly scanning requirements that needed to be stored in a readily accessible document repository – a lost file, in this case, could mean a medical device recall
  • Must include a process to provide device history and manufacturing run information for FDA requirements

The Solution

IOS makes weekly pickups and deliveries of over 7 million images per year for import into the client’s Oracle Imaging System. IOS uses recognition software to read them and capture the corresponding part number and work order number data fields. To establish a validated delivery, IOS created custom processes using data provided by the client to ensure accuracy and traceability for the client.

Weekly, the client passes to IOS a data file representing all lot control device histories that have been manufactured. IOS processes the data and concatenates the part number data and the work order number data to create a unique record to track.

Based on business rules established, IOS monitors this data set and reports back to the client on all device histories that we expected to receive but are still missing, and a second list of items we received and processed that were not included in the data passed from client.

The Bottom Line

  • The IOS solution has not only increased the accuracy of the Lot Control capture process, but has allowed the client to prove that it is in compliance with all FDA records keeping requirements for its medical device implants.
  • Their business is more effective and the software created by IOS has been so beneficial that the client has expanded its use in other areas of its business.

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