OpenText GxP Document Management System for Content Suite Platform by Stratesys
By STRATESYS TECHNOLOGY SOLUTIONS, SL
GxP Document Management System for Content Suite Platform by Stratesys eDMS is a modular solution part of GxP Suite and designed to help the Quality department of a Life Science organization to improve and innovate its Quality Management System. Covering the fully Controlled Documented Information (CDI) lifecycle from the creation to the employee training, allowing a 360º vision of the regulated documentation process, and automating the review, approval and distribution activities related to them. The solution can also be configured to leverage the functionality provided by Extended ECM for SAP, to reduce the time of the Batch Production Record (BPR) generation process.
Product Highlights
• Task oriented 100% mobile user interface to improve productivity and adoption
• Manage CDI lifecycle with out-of-the-box workflows for Creation, Renewal, New Version and Obsoleting
• Preconfigured security model with predefined roles
• Automated Periodic Review and Document Change Order processes
• Set of pre-defined document types based on industry best practices
• Full audit trail of all user actions in the application (electronic signature)
• Enable access to external users for task completion and content secure access
• Automatic link of CDI to BPR based on SAP production data (material, plant, etc.)
• Enable collaboration with OpenText Brava! or Microsoft Office 365
Value Proposition
• Unify CDI processes across all business groups speeding-up regulatory audits and process failure identification
• Simplify user adoption and reduce training costs
• Accelerate application validation with pre-validated documentation (URS, FRS, DS, and IQ)
• Simplified maintenance with Business Users administration tools