Fully Compliant Enterprise Collaboration and Content Management
Inference Repository is an enterprise collaboration and document management solution specifically designed for companies implementing QbD in a regulated environment. Inference Repository provides a rich collaboration environment tightly integrated with document and records management functions, including support for compliance with FDA 21 CFR Part 11 for electronic records and signatures. Versioning, check-in/check out, auditing, security, workflow, reporting, and retention policies assist with managing electronic QbD documents and records. These advanced features are designed to address the following business needs:
- Centralized collection, sharing and management of QbD documents
- Versioning to enable rollbacks and to ensure proper audit trails
- Flexible security to manage access to documents and functions
- Controlled access to Inference for QbD Templates to minimize errors and redundant effort
- Change control of validated Inference for QbD Function Libraries and Inference for QbD Template Libraries
- Automated workflows to enable control of the document life cycle from creation to archival
- Universal digital signatures to provide embedded signatures that protect the authenticity of signatures in Inference Word and Excel documents and in PDF data-analysis results documents
- Document retention policies for records management
Built on top of the leading collaboration and content management platform, Microsoft Office SharePoint Server 2007, Inference Repository enables access to QbD project information through an easy-to-use web interface. Users can access, share, and manage documents from anywhere.