Ensuring Quality and Regulatory Compliance
If a product doesn’t meet today’s strict quality, safety, and regulatory compliance mandates, it will not realize commercialization success. Manufacturers must adhere to an ever-changing myriad of laws, standards, and regulations to sell their products globally.
The nature of compliance varies across industries and countries:
- Life Sciences and Medical Device Compliance: Companies that are subject to FDA (U.S. Food and Drug Administration), ISO (International Organization for Standardization), EU MDR (European Union Medical Device Regulation), and other key industry regulations can mitigate compliance risks by ensuring policy, process, and system adherence. For example, the FDA and EU MDR require life sciences companies to establish and maintain a quality system to ensure that medical devices meet all safety and performance requirements.
- Environmental Compliance: All electronics manufacturers must limit or restrict the use of toxic materials in products. This involves managing components and material compliance evidence for RoHS (Restriction of Hazardous Substances), REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), WEEE (Waste Electrical and Electronic Equipment), and/or conflict minerals regulations.
- Export Controls: These vary by country. However, aerospace and defense companies that do business with the U.S. government or military are subject to International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR). ITAR- and EAR-related product data must be controlled, and, if exported, done so only with proper export licenses.
Cloud PLM and QMS solutions streamline regulatory compliance by providing a central repository for product teams and supply chain partners to compile all the necessary evidence. Through frequent communication and coordination, they can ensure that technical files, material declarations, validation reports, training records, SOPs, CAPAs, and other documentation are up to date. Having a unified system to manage, track, and access the latest information also provides greater visibility and traceability, thereby minimizing audit risks.