Common use of Document Control Clause in Contracts

Document Control. Supplier must have a suitable document control and record retention policy that complies with applicable regulatory requirements for the Products. Supplier shall establish and maintain design records, manufacturing records and quality records for each type of Product in accordance with applicable regulatory requirements. Supplier shall provide Distributor upon request with copies of such records free of charge, in cases (a) necessary for Distributor to execute its obligations under the Distributor Agreement and (b) in a timely manner, if required by applicable laws or regulations Supplier shall establish and maintain a Design History File (“DHF”), as described in article 17, for each type of Product. In case of changes, the DHF grows further during the maintenance phase of the Product. All changes, including all related applicable information such as revised specifications, (new) calculations, hazard analyses and test reports, must be continually added to the DHF during this phase. Supplier shall establish and maintain a Device Master Record (“DMR”), as described in article 17, for each type of Product. The DMR must be in place at start of regular production, including pre-production. Supplier shall establish and maintain a Device History Record (“DHR”), as described in article 17, for each individual Product. For each manufactured Product, including those from pre-production, a DHR must be in place before delivery to the Customer. Supplier shall archive these records for a period of 15 years unless other retention time is needed by local regulatory requirements, and on request, provide Distributor with a copy thereof free of charge in cases (a) necessary for Distributor to execute its obligations under the Distributor Agreement and (b) in a timely manner, if required by applicable laws or regulations.