Documentation and Document Management Clause Samples

Documentation and Document Management. Product Provision must be planned and will be carried out under controlled conditions. Accordingly, [Supplier] is responsible for ensuring that all documents establishing and verifying the requirements for Product Provision are produced. Such documents include, without limitation, Product specific documents relating to the processes: - Development (sampling / verification, process validation) - Production process from receipt of goods until delivery - Change control - Complaint handling / deviation management [Supplier] is responsible for generating, documenting, controlling and updating all quality- related data (instructions, records and specifications). The documentation is to be kept protected in such a way that it is available and readable for the entire preservation period and so that any alteration to it is evident. [Supplier] will ensure that the Documents are preserved for at least fifteen (15) years after the last delivery of Product to Ypsomed, whereas the following rules shall apply: a) Original Documents (in paper form) will be preserved for at least 7 years after the last delivery of Product to Ypsomed; b) Prior to the expiry of the seven (7) year period set out in lit. a) above, [Supplier] will ensure that for at least another eight (8) years either (i) the Original Documents (in paper form) will be preserved under the same archival conditions or (ii) a verifiably identical electronical (e.g. pdf) copy of the original Documents will be preserved in a secure way. If [Supplier] intends to destroy or delete the Documents on expiry of the overall fifteen (15) year period, it must first inform Ypsomed. Ypsomed may claim possession of the documents (in paper or electronical form respectively). Upon termination of this QAA, [Supplier] provide the pre-mentioned Documents to Ypsomed. [Supplier] is allowed, but not obliged to keep one copy of such Documents.