Why Might You Need Help With Materials and Regulatory Compliance?
Across all industry sectors there is growing demand from customers and regulatory authorities for companies to accurate report on compliance of both materials and documentation; and the requirements for compliance is becoming a major focus within the planning and operational processes of their businesses. The need to adhere to ever stricter industry and governmental standards must be enveloped into the structure of organisation so as not avoid punitive financial penalties.
The Materials and Regulatory Compliance requirements cover a large number of standards including:
RoHS, REACH, ELV, (ELV+RoHS), GADSL, IMDS, REACH, RRR, IPC 1752, JAMP AIS, and JAMA JAPIA, WEEE. In addition there are additional specific requirements for Lifesciences with FDA 21CFR Part 820.198, Part 803 and ISO 13485; associated documentation (21 CFR Part 11, ISO, SOX, EMEA, NRC, NERC, etc) and UDI submission (IDE,PMA,510K,CE),
How Can Design Rule Help?
The 3DEXPERIENCE platform delivers a single web based Product Lifecycle Management platform to support businesses subject to some or all of the above requirements; and within the context of their particular industry requirements. It delivers a powerful solution to ensure that the proper protocols and procedural documentation are followed and collected. Through the use of the Product Lifecycle Management (PLM) system, organisations can manage and access all relevant information and documentation for a central, globally accessible location. In terms of multi-site manufacturing, a project manager can directly access information relating to the required standards for material compliance for anywhere in the world, ensuring that regulations for the intended place of sale are followed. This can lead to a reduction in production times and increase the speed of delivery to market.
It also allows designers to access information of safe materials standards within the design process and directly link these to a material BOM; ensuring safe, compliant products are produced. This can lead to fewer errors during the design to production cycle and as such, a reduction of risk exposure to the organisation.
Materials and Regulatory Compliance solutions include:
- Material compliance solutions for Management, Analysis and Declarations with interfaces to 3rd party materials databases
- BOM Materials compliancy analysis and reporting
- Life Sciences compliance solutions for documentation and DMR, etc
- Lifesciences Global Marketing Registration solution for regulatory submissions
To find out more information about how Design Rule can help you with materials and regulatory compliance, contact us online.