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.
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Samples: Supplier Quality Agreement, Supplier Quality Agreement, Medical Device Quality Agreement
Automated Processes. 3.4.1. 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.
3.4.2. The Supplier shall keep records of these activities and make them available to the Customer upon request.
Appears in 1 contract
Samples: Supplier Quality Agreement
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.
Appears in 1 contract
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. Refer to Hana procedure no. 003-0405 for Test and Programming Software Control. The Supplier shall keep maintain records of these activities and make them available to the Customer upon request.
Appears in 1 contract
Samples: Quality Agreement (Kindara, Inc.)