It’s important to recognize that there are FDA Quality System Regulation and ISO 13485 requirements that govern the use of electronic systems [software such as ERP, MES, WMS, PDM, etc] in all forms of medical device manufacturing companies including medical contract manufacturing environments.  Medical device companies must ensure the appropriate steps are taken when implementing new business management software or up-revving current software.

In the FDA QSR, Part 820, Section 70(i) Production and process controls, automated processes, indicates that when computers or automated data processing systems are used as part of production or the quality system, the device manufacturer / medical device contract manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. The key to these activities is documentation. Medical device companies should not only focus on documenting results but the sequencing of events prior to execution.

ISO 13485 indicates that medical device companies must establish documented procedures to validate the application of computer software, and changes to such software and/or its application. Medical device manufacturing / medical device contract manufacturing companies must also establish procedures around service provisions that affect the product’s ability to conform to specified requirements.  Again, like the FDA QSR, Part 820, Section 70(i), these software applications must be validated before initial use.  Validation records must be recorded.

This is a great starting point in evaluating the policies and procedures around software validation requirements for medical device companies.

Scott Cook
Director of Quality and Compliance