What is the difference between controlled and uncontrolled documents

For example, pharmaceutical product records must be kept for at least one year after the expiration date. Document destruction is equally important to dispose of controlled documents when the retention time has passed. Even the destruction process must be controlled. Uncontrolled documents should also be retained and disposed of according to the requirements of the DMS retention policy.

However, the requirements around retaining and disposing these documents are not so strict. In the case of uncontrolled documents, document retention and destruction are more of a good business practice rather than a regulatory requirement.

Controlled documents must be stored in such a way as to ensure the information within is not compromised. Controlled electronic records must be protected from unauthorized change, loss, or damage during storage.

For paper documents, fireproof and flood-proof file cabinets can provide the needed protection. For electronic documents, electronic storage must protect from physical hazards, and backup procedures must be established and followed.

Electronic-controlled document storage and preservation systems must be validated. Examples of uncontrolled documentation could be those relating to routine administrative tasks, such as production schedules or overall equipment effectiveness trackers. An effective QMS includes a document management system for all document types. Just because a document is uncontrolled does not mean it is not important. Document management systems need repositories for both controlled and uncontrolled documentation.

Document Control Checklists. Document Controller: A Career Roadmap. Write a comment. Karen Monday, 21 January Hi Julie Thanks for the continued information have agreed with your comments to date and trying to elevate D C as a profession is one of my highest priorities hope that with you permission i am able to paraphrase and use some of this gold. Keep up the great work Karen. MAhir Saturday, 06 July Record and document management. What are your record and document management obligations?

Checklist: Records you are required to keep What documents should you keep? Checklist: Documents you are required to keep Controlled and uncontrolled documents When should your documents be protected by legal professional privilege? How to manage your records and documents Checklist: What to include in your document management policy Record and document management standard What if you fail to meet your record and document management obligations? Sign up today for 5 free topics!