Document Control Module
Scope
The uniPoint Document Control Software Module is the focal point of our quality management system because it manages all types of documents, regardless of the software used to create them. It provides a central and secure repository that makes search and retrieval easy during inspections and audits.
Advantages
Improve efficiency and compliance requirements, including FDA CRF Part 11, by automating your manual document control with sign-off and strict revision control. Ensure that your company is building its products using the most current specs. Other advantages are:
Key Features
- Helps customers achieve/maintain compliance to FDA 21 CFR Part 11 and Part 820
- Track all Company Documents (grouped by type and category) in a master database.
- Ability to control document approval sources, and complete distribution lists on a per document basis
- Track status of documents (active, pending, obsolete)
- Track document revision changes, and quickly copy old revisions to new revision, complete with existing approval and distribution lists
- Ability to search, list, find all company documents by status or distribution
- Ability to Link to actual document file path, or web page, and view document on-line
- Excellent tool for confirming status of documents and distributions during audits
- Digital Signatures
- Encrypted Sign-off Passwords
- Optional Strict Revision Control
- Increased Management Visibility
- Advanced Search Tools
- Setup Sign-off/Distributions
- Email Revision changes to Employees
General Capabilities
- Specific E-mail Notification
- Standard Text Manager
- Unlimited Attachments
- Update User To-Do Lists
- See Historical Audit Trail
Reporting
- Document Report, with digital signature
- Document Reviews
- Document Distribution List
- Document History Report
- Document Acknowledgments Outstanding
- Document Acknowledgment History
- Document Sign-Offs Outstanding
- Document Sign-Off History
Advanced Features
- Consolidate documents automatically into a specified location
- Have complete control over versioning and changes with check-in and check-out
- Control access to files with user level security
