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What is document control?
- Document Control involves creating and enforcing a set of control processes and practices that govern the creation, review, modification, issuance, distribution and accessibility of documents.
- A document control system is among the most critical tools for compliance in highly regulated industries such as medical device development and manufacture.
Good documentation practice (GDocP)
- GDocP not only helps during regulatory inspections (audits), it is mandatory to ensure documentation practice (and products) meet industry standards and the legal requirements for safety, efficacy and product quality.
GDocP Key Points
1. All controlled documents should have
- Unique document number
- Revision number
- Numbered pages
2. Use only approved versions of documents.
3. When completing a record, you must ensure that you are using the current version of the document.
4. Always use pen to complete entries on a physical record - you must make sure that the handwriting is legible.
- It may be used as evidence that the activity was completed (for instance, in an external audit), so the entry needs to be readable.
5. Correction fluid, sticky labels etc. must not be used to cover errors.
6. Always complete records at the time that they are being carried out.
7. Always date signatures on the day that the record/document is being signed. You MUST NOT backdate your signature.