Compliance Management

Leveraging Omnify to Meet Compliance Requirements

Today, Regulatory Compliance has become an important aspect and daunting challenge for manymanufacturers.


Whether your company is concerned with Environmental/Recycling-based initiatives relating to electrical and electronic equipment, such as:

  • RoHS, WEEE, China/Korea/Japan RoHS, etc. directives
  • IMDS, IPC-1752, JIG, etc. data standards

 

or you need to meet Food and Drug Administration (FDA) regulations, such as:

  • 21 CFR - Part 11
  • 21 CFR - Part 820

Omnify PLM can provide you with the necessary technology to meet these needs.
 

Environmental Compliance (Back to top)

Today, doing business globally means compliance with the European Union Directives, Restriction of Hazardous Substances (RoHS) and Waste Electrical and Electronic Equipment (WEEE). The financial and technological requirements of these Directives has altered the business and product development processes for electronic manufacturers. Going "green" and transitioning to a RoHS compliant organization requires investments of people, time and resources.

Electronic manufacturers are faced with challenges on how to handle their product design and development. Environmental regulations will continue to evolve as various countries initiate their own directives. It is extremely important that manufacturers implement flexible systems and processes that can adapt to this environmental movement.

Omnify Software helps companies manage product development under the new regulations by allowing easy classification of parts as either compliant or non-compliant, identification of the complete material composition of a part, and the ability to search on this information and export it into a Bill of Material (BOM) report for quick analysis. In addition, Omnify provides a location to store and manage all of the necessary compliance documentation associated to a part (materials declarations/certificates of compliance/IPC-1752 forms).

Omnify PLM helps OEMs meet RoHS and WEEE compliance by enabling them to:

  • Identify the complete material composition of a part
  • Easily classify parts that meet (or do not meet) RoHS/WEEE or other environmental requirements
  • Export data into a report for quick analysis of pass/fail parts
  • Store all required compliance declarations/certificates associated with a part
  • Properly maintain records of products in a "technical file" required by EU authorities
  • Facilitate material composition data exchange throughout the supply chain by supporting the IPC-1752 specification for materials declarations

 

Download the Omnify PLM RoHS Compliant Product Development Datasheet

FDA Compliance (Back to top)
Medical manufacturers who track their documentation electronically and must maintain records or submit information to the Food and Drug Administration (FDA) are subject to the FDA regulation CFR Part 11 of title 21 of the Code of Federal Regulations (21 CFR Part 11). To be compliant, medical OEMs must meet the electronic records and electronic signature guidelines set forth by the FDA.

Some medical device manufacturers are also required to meet the FDA 21 CFR Part 820 Quality System regulation. This requires device manufacturers to have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.

The Omnify PLM system helps medical device and medical equipment manufacturers fulfill these FDA requirements with:

  • A controlled environment to manage all of your product data (bill of materials management, documentation control, change control, CAPA/quality management, training)
  • Complete history tracking for electronic audit trails
  • Password-protected signoffs and authorized signatures to manage user authentication and authorization
  • Easy reporting and analysis (custom reports, DMR/DHR/DHF reports, customizable dashboards)
  • Defined user roles to control accessibility
  • Closed-loop Corrective and Preventive Action (CAPA) system

Training record management

Download the Omnify PLM FDA Compliance Datasheet