In the FDA [[Design Controls]] ''//Document Control//'' is the enumeration of design documents, and tracking their status and revision history.  Throughout this section, the term “document” is used in an inclusive sense to mean all design documents, drawings, and other items of design input or output which characterize the design or some aspect of it.

The features of a manufacturing document control system typically include the following:
* Documents should be identified (i.e., named and numbered) in accordance with some logical scheme which links the documents to the product or component they describe or depict and illuminates the drawing hierarchy. 
* A master list or index of documents should be maintained which presents a comprehensive overview of the documentation which collectively defines the product and/or process.
* Approval procedures should be prescribed which govern entry of documents into the document control system.
* A history of document revisions should be maintained.
* Procedures for distributing copies of controlled documents and tracking their location should be prescribed.
* Files of controlled documents should be periodically inventoried to ensure that the contents are up to date.
* A person or persons should be assigned specific responsibility to oversee and carry out these procedures.
** It is desirable that the document control system be administered by a person who is not directly involved with developing or using the documents.
** For a small manufacturer, document control might be a part-time job for a technician or clerical staff person.  More typically, one or more librarians or full-time clerical or paraprofessional employees are required to administer the system.
* There should be a procedure for removal and deletion of obsolete documents
bag
fda_public
created
Sun, 22 Jul 2012 13:35:38 GMT
creator
dirkjan
modified
Sun, 22 Jul 2012 13:35:38 GMT
modifier
dirkjan
tags
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Term
creator
dirkjan