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SOLIDWORKS Regulatory Compliance

The SOLIDWORKS PDM (PDM) system helps companies in regulated fields (like medical device development) comply with government regulatory requirements or industry standards for controlled development processes and product documentation by increasing operational efficiency, ensuring regulations are met,and generating the information needed to demonstrate compliance.

SOLIDWORKS PDM takes just weeks to implement—not the months needed by other systems—to improve both processes and documentation performance. Its high user acceptance and low total cost of ownership enable compliance efforts to be improved quickly and affordably, providing a rapid return on your investment.

Regulatory Examples

SOLIDWORKS PDM can bolster compliance with the following regulatory requirements:

  • United States FDA (Food and Drug Administration) 21 CFR Part 11
    • Manage all FDA-related documents electronically
    • Get quick access to standard operating procedure (SOP) information using the system’s Advanced Searching tools
    • Access and produce document audit trail and history information, and quickly respond to on-demand compliance and reporting requests
    • Adhere to and enforce double electronic signature security requirements
    • Establish a framework that enables you to maintain and control file versions and revisions
  • European Union RoHS (Restriction of Hazardous Substances)
    • Track material usage in electronic products
    • Access material usage information quickly
  • ITAR (International Traffic in Arms Regulations)
    • Create and maintain a secure data environment
    • Provide granular file access control for users and groups
  • Quality Management Systems (ISO 9001, TS 16949, ANSI, ISO 14000)
    • Access to standard operating procedure (SOP) information quickly using the system’s Advanced Searching tools
    • Access and produce document audit trail and history information
    • Establish and maintain consistent business processes using the system’s Electronic Workflow
  • SOLIDWORKS 2017 Minnesota Wisconsin North Dakota South Dakota
  • SOLIDWORKS VAR Reseller Wisconsin North Dakota South Dakota Minnesota
  • SOLIDWORKS VAR Reseller Wisconsin North Dakota South Dakota Minnesota
  • SOLIDWORKS VAR Reseller Wisconsin North Dakota South Dakota Minnesota

SYMMETRY SOLUTIONS, INC.

Your official SOLIDWORKS 3D CAD software and training provider for Minnesota, Wisconsin, North Dakota and South Dakota.

Contact SOLIDWORKS ResellerWant to talk?
Call us at 763-560-8600

Email SOLIDWORKS ResellerNot a big talker?
Email us at info@symsolutions.com

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