ABSTRACT
Documentation is a system, which manages and controls all documents during various activities performed in a pharmaceutical organization. Regulatory auditors rely highly on what the documents tell them. If it is not documented, it has not been done. The purpose of good documentation practices is to clearly document the actions that took place in the development, manufacture, testing and releasing for commercial use of a drug, biologics, vaccine, medical device, and so on. Documentation is required to assure the safety, identity, strength, purity and quality of the drug product and incorporates the following issues: responsibility and authority (for access, review, change, approval, issuance); control of routing, circulation, distribution and retrieval; interrelationships and consistency between documents; ”ling, traceability, retention, destruction, back-up and security; and quality (accurate, thorough, concise and timely). A controlled record is considered a legal document, so the data needs to be clearly documented for legal and preservation purposes.
