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Enterprise PDM
How SolidWorks Enterprise PDM (EPDM) Helps Companies with Regulatory Compliance Lisa J. Costa CADD Edge, Inc. Pre‐sales Manager, PDM/PLM Group April 2010 Confidential Information Agenda Single Repository for all Product Related Data Audit trail/History – SolidWorks and other Windows file types as well as system-wide setup Documented & Repeatable Process Electronic Approval/Change Tracking Double Signature – required by FDA CFR Part 11 regulation l ti Confidential Information EPDM – Single Repository for all Product Related Data organization Other CAD data Confidential Information EPDM – Single Repository for all Product Related Data Publish Simulate Manage Design Confidential Information EPDM – Controlled Access to all Files & Actions Confidential Information EPDM – Audit trail/History Confidential Information EPDM – Audit trail/History Confidential Information EPDM – Documented & Repeatable Process SolidWorks Enterprise PDM Flexible Workflow Confidential Information EPDM – Electronic Approval/Change Tracking SolidWorks Enterprise PDM Flexible Workflow Confidential Information FDA Regulations that EPDM Helps to Address The 21 CFR Part 11 consists of a number of rules pertaining mainly to: Creation and Protection of Electronic Records Access Authorization and Security T Traceability bilit and dA Audit dit T Trailil on allll electronic l t i records d Requirements for electronic signature SolidWorks Enterprise PDM provides solutions to help capture documents, processes and procedures to adhere to regulations as specified in the FDA 21 CFR Part 11 Rule Confidential Information EPDM – Double Signature Requirement Confidential Information EPDM Packaging Floating & Concurrent Floating & Concurrent Worldwide MS SQL Server MS SQL Server Scalable Solution XP, Vista , Win 7 32 ‐ 64 Bit Flexible Workflow Flexible Workflow No Limits CAD Integrations ‐SolidWorks ‐ACAD, Inventor ‐Pro/E ‐Solid Edge SolidWorks Enterprise PDM ‐eDrawings g Professional ‐Full BOM Replication Replication Multi Site Confidential Information In Conclusion – EPDM and Compliance Single Repository for all Product Related Data • CAD and other file vaulting; secure and controlled access • Product documentation, easy viewing for other groups Audit trail/History Audit trail/History • Files & System Configuration • Date & Time stamp • User name • Action Documented & Repeatable Process Electronic Approval/Change Tracking Double Signature – required by FDA CFR Part 11 regulation Confidential Information Thank You! www.solidworks.com www.solidworks.com/pdm_pains www.caddedge.com caddedge com [email protected], Phone: 978.505.9039 Confidential Information
