21 CFR 820 - 820.40 document controls

Original text

Expert opinion

Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:

(a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

(b) Document changes. Changes to documents shall 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 shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall 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.

As it is very common nowadays to control documents digitally in so-called document management systems (DMS), there is no requirement for it. Thus, paper-based documentation is, in regards to document controls, allowed.

In any case, however, written procedures must been implemented to define how document controls are conducted. It is insufficient to just refer to the DMS and its source code.

a) Per document, it must be defined who is to review and/or approve a document after it has been newly created, changed or being archived. The reviewer and approver have not necessarily to be the same person. The distribution of released documents must be guaranteed and made available to each location it is assigned to. This includes different sites, offices, labs, clean rooms, manufacturing alleys, etc. It hast to be assured that only the current version of a document is made available at each individual location and former or obsolete versions need to be removed promptly. Obviously, this is an easy play with a DMS and assuring access points at all locations, but sometimes and specifically in manufacturing areas, physical copies are needed. Such copies need to be controlled and potentially marked as “controlled copy”
b) As with the creation of documents, the change of a document needs to be reviewed and released by authorized and assigned persons. Changes need to be communicated to the personnel involved in working with the document. This has to be in a timely manner, and the common agreement of “timely” is 30 days after the document has been put into effective. The document should include a history of its changes and description thereof, including potential other affected documents along to the Good Documentation Practice (GDP) details, such as signature of the approver, approval date and date of being effective. The regulation does not specify whether the signature has to be physical or a digital signature is sufficient, giving way to the use of a DMS.

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