There are several regulations which state out the Document Control Requirements. The regulations which apply to an organization depend on the territory in which the organization intends to sell medical device products. An organization intending to do business in Europe is required to comply with EU MDR and EU MDD. Whereas organizations intending to do business in the USA are required to comply with 21 CFR Part 820.
There is not a drastic difference in what these regulations demand. Apart from regulations, there are some international standards such as ISO 9001:2015 and ISO 13485:2016, which also specify standards of establishing Document Control. Complying with these international standards prepares organizations for regulatory compliance.
The 21 CFR Part 820 of Federal regulations deals with Quality System Regulation. The 21 CFR 820.40J of Federal Regulation Requires Each manufacturer to establish and maintain procedures to control all required documents by part 820. The procedures are required to provide for the following:
(a) Document approval and distribution. Each manufacturer is required to designate an individual(s) to review for adequacy and approve before issuance all documents established to meet the requirements of 21 CFR Part 820. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet 21 CFR Part 820 requirements must be available at all locations for designated, used, or otherwise necessary. All obsolete documents are needed to be promptly removed from all points of use or otherwise prevented from unintended use.
(b) Document changes. Changes to documents must be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval unless specifically designated otherwise. Approved changes are required to be communicated to the appropriate personnel promptly. Each manufacturer is needed to maintain records of changes to documents. Change records are needed to include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.
If you are a Scilife user, you do not have to worry about complying with these requirements. Scilife helps you to automate all the document control policies and procedures in your organization.
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