Company: Aap Implantate AG
Product: Orthopedic implants
Date: 7/16/04

Failure to validate, according to an established protocol, computer software for its intended use, when that software is used as part of the Quality System or part of production as required by 21 CFR 820.70(i), Automated Processes.

The regulation under 21 CFR 820.70(i) requires that when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.

The …software used in the design and development process is not validated.

The…software used for inventory and process control has not been validated for its intended use

The March 05, 2004 response indicates that your firm would provide the missing validation information for the …software programs by July 2004. The response is not adequate. Please provide the software validation protocols for these three software programs and explain how your firm plans to prevent this error from recurring in the future.

Issuer: Center for Devices and Radiological Health (CDRH)