The solution provides a comprehensive set of out-of-the-box functions and capabilities that help companies facilitate compliance to the FDA's 21 CFR 11 standard by providing auditing, reporting, security and more.Specifically designed for the Life Sciences and Pharmaceutical industries, the Document and Quality Management System for Alfresco helps organizations automate and streamline their paper processes for increased efficiency and regulatory compliance.
The solution incorporates advanced workflow technology for creating and modifying Standard Operating Procedures (SOPs) to provide you an essential solution for regulated industries with formal approval processes and those that follow Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP).
Additional capabilities include a Change Control workflow for the annual review of documents and an advanced workflow for handling Corrective Action and Preventive Action (CAPA) activities.
Features and Functions
The solution includes support for:
- Change Controls
- Management of SOPs
- CAPAs
Compliance framework which provides:
- Digital / Electronic Signatures
- Audit Trails and Reporting
- Watermarks and Overlays
- Lifecycles
- Auto-numbering
- Advanced Versioning
- PDF Renditions
- Controlled Printing
- Advanced Workflows
Benefits
- Reduce costs by eliminating paper
- Improve efficiency by using an automated workflows
- Achieve compliance with regulatory requirements
- Reduce processing errors by eliminating manual processing tasks
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