Quality documents are the foundation of operations for Medical Device and Pharmacetical companies, and cover product recipes, Standard Operating Procedures (SOPs), Change Controls, and differnt EIT and FDA mandated electronic documents.
These documents are managed by a defined lifecycle that controls authoring, review and approval, training and distribution and effectivity. Automating this lifecycle is critical to maintain compliance and increase effeciency.
Managing the Quality Document Lifecycle
The solution provides a standard controlled lifecycle that allow complete quality lifecycle to be managed:
- Authors can create new quality documents or revise existing ones
- Authors can collaborate with other users in a peer review
- Once complete, the document can be routed for electronic approval. The approvers are defined in a matrix depending on the quality document category
- Approval contains 21 CFR Part 11 Electronic signature support which add a signature manefest to the document. The appropriate users are notified of the approval to allow time for training
- The document can then be manually or automatically placed into an effective state with periodic review support
Every action to each quality document is recorded in "human" readable audit trail that can be viewed and reported on.
Reporting and Tracking
Administrators and quality representatives can track documents and report on meta-data to provide complete traceability on where the documents are in the process.