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
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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
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EPDM – Single Repository for all Product Related Data
organization
Other CAD
data
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EPDM – Single Repository for all Product Related Data
Publish
Simulate
Manage
Design
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EPDM – Controlled Access to all Files & Actions
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EPDM – Audit trail/History
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EPDM – Audit trail/History
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EPDM – Documented & Repeatable Process
SolidWorks
Enterprise PDM
Flexible Workflow
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EPDM – Electronic Approval/Change Tracking
SolidWorks
Enterprise PDM
Flexible Workflow
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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
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EPDM – Double Signature Requirement
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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
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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
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Thank You!
www.solidworks.com
www.solidworks.com/pdm_pains
www.caddedge.com
caddedge com
lcosta@caddedge.com, Phone: 978.505.9039
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