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Tag: "Product: ISO 13485/Procedure for Document and Record Control" - Expert Advice Community

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  • Question about records

    We are working on the procedure for Document and Record Control and some questions have come up. 

    Can you help explain what types of records need to be recorded?

    Do we need to list all the types of records and why would we need it? 

    Would a CAPA be a record or a document?

  • Procedure for document and record control- the incoming mail register

    Please can you assit me. With regards to the Procedure for document and record control- the incoming mail register.. I do not see an appendix for this document? Must I create it? Also how necessary is this section if there is only the managing director of the company and no other employees?