Automated Processes. When com- puters or automated data processing systems are used as part of production or the quality system, the manufac- turer shall validate computer software for its intended use according to an es- tablished protocol. All software changes shall be validated before ap- proval and issuance. These validation activities and results shall be docu- mented.
Appears in 6 contracts
Sources: Quality Management System Agreement, Quality Management System Agreement, Quality Assurance Agreement