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Home » Solutions » Compliance Management: Environmental Compliance | FDA Compliance
Today, Regulatory Compliance has become an important aspect and daunting challenge for many manufacturers.
Whether your company is concerned with Environmental/Recycling-based initiatives relating to electrical and electronic equipment, such as:
  • RoHS, WEEE, China/Korea/Japan RoHS, REACH, etc. directives
  • Conflict Minerals Trade Act
  • 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 RoHS (Restriction of Hazardous Substances), REACH (Registration, Evaluation, Authorization and restriction of Chemical substances), and WEEE (Waste Electrical and Electronic Equipment) directives. The financial and technological requirements of these Directives has altered the business and product development processes for electronic manufacturers. Going "green" and transitioning to an environmentally 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 offering the ability to easily classify parts as either compliant or non-compliant, identify the complete material composition of a part, automatically manage and trace all product/supplier changes, and the ability to search on this information and export it into a Bill of Material (BOM) report for quick analysis or to demonstrate conformance for regulatory agents. 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).
OEM customers can meet RoHS/WEEE/REACH/Conflict Minerals compliance by using Omnify Empower PLM to:
  • Identify the complete material composition of a part
  • Easily classify parts that meet (or do not meet) RoHS/WEEE/REACH/Conflict Minerals or other environmental standards
  • Manage and trace all product and supplier changes
  • 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 authorities
  • Facilitate material composition data exchange throughout the supply chain by supporting the IPC-1752 specification for materials declarations
Datasheet Download Download the Environmental Compliance with Omnify Software 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 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.
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:
Datasheet Download Download the FDA Compliance with Omnify Software Datasheet

Compliance Management

RoHS Management (PDM)

FDA Regulation Compliance