Document control as per ISO 13485

Why it is Required to have Document Control ?

1. It is required by both FDA (in Federal, Food, Drug, and Cosmetic Act) and European Community (in ISO 13485)
2. Has always been a requirement, from 1976 (GMPs) and 1996 (ISO)
3. Cited regularly by both FDA inspectors and notified body auditors as deficient
4. Often ignored by upper management as an area for possible streamlining

FDA Requirements of Document Control:

1. Sec. 820.40(a) Document approval and distribution
   –Approval : …designate an individual(s) to review for adequacy and approve …all documents.
   –Approval – date and signature(s) – shall be documented.
   –Distribution
   – Documents …shall be available at all [necessary] locations
   – All obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.
2. Sec. 820.40(b) Document changes
   –Changes to documents shall be reviewed/approved by an individual(s) in the same function/organization that performed the original review/approval, unless 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)
   • Approval date
   • Effectivity date

ISO 13485 requirements

As per Clause 4.2.3 – Control of Documents

1. A documented procedure shall be established
   a) review and approve documents prior to issue
   b) review and update as necessary and re-approve
   c) ensure that changes and current revisions are identified
   d) ensure that relevant versions of applicable documents are available at points of use
   e) ensure that documents remain legible/identifiable
   f) ensure that documents of external origin are identified and their distribution controlled
   g) prevent unintended use of obsolete documents, and apply suitable identification if retained
2. Changes to documents must be reviewed/approved either by original approving function or another designated one that has access to pertinent information upon which to base its decisions.

Features of a document control system

1. Requester of change red-lines documents and completes change request
2. Requester submits red-lined documents and change request to Document Control
3. Document Control supervisory personnel reviews red-lined documents and change request to assure completeness and accuracy
4. Document Control personnel incorporates changes into current documents
5. Document Control personnel distributes revised documents for review/approval
6. Approval of document package
7. Distribution of new documents to appropriate work areas
8. Work areas either destroy obsolete versions or return them to Document Control
   

How to Streamline a document control process

1. Requester of change red-lines documents and completes change request : If MS Word document, use Tools/Track Changes/ Highlight Changes
2. Requester submits red-lined documents and change request to Document Control : Via e-mail
3. Doc Control supervisory personnel reviews red-lined documents and change request
4. Document Control personnel incorporates changes into current documents : Tools/Track Changes/Accept or Reject Changes
5. Document Control personnel distributes revised documents for review/approval : Via e-mail
6. Approval of document package : In Outlook, New Message/Options/Voting and Tracking Options/Use Voting Buttons
7. Distribution of new documents to appropriate work areas
   • Document Control scans originals
   • Puts them in appropriate directory
8. Little or no need for destruction/return of obsolete versions