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.
Automated Processes. If the Supplier uses computers, software, or other automated methods as part of the production process, the Supplier shall validate the computer software for its intended use. The validation process shall create a validation protocol (describing the planned activities) and a validation report (documenting the outcome of the planned activities). All software changes shall be similarly validated prior to use. The Supplier shall keep records of these activities and make them available to the Customer upon request.
Automated Processes. If ZIEN uses computers, software, or other automated methods as part of the production process, ZIEN shall validate the computer software for its intended use. The validations process shall create a validation protocol (describing the planned activities) and a validation report (documenting the outcome of the planned activities). All software changes shall be similarly validated prior to use. ZIEN shall keep records of these activities and make them available to CPI upon request.
Automated Processes. In the event that computers or automated data processing systems (i.e., hardware and software) are used as part of the production of the Product and/or Supplier’s Quality Management System, then Supplier shall be responsible to validate computer software and associated equipment for its intended use according to a written protocol and in accordance with QS Regulations/cGMPs and FDA/Regulatory Agency guidance/information documentation concerning software validation. Supplier shall be responsible to ensure that all software changes shall be validated before approval and implementation; and, all such validation activities and results shall be documented, in accordance with ISO 13485 7.5.2. (Validation of Processes for Production and Service Provision).
