PLM and QMS software solutions help today’s sophisticated manufacturers get safe, high quality products to market fast. Both systems bring electrical, software, and mechanical designs together into a single source of truth. However, QMS systems also ensure strict compliance with Food and Drug Administration (FDA), International Organization for Standardization (ISO), European Medicines Agency (EMA), or other directives before medical device manufacturers, biotechnology companies, or other life sciences organizations can sell their products.
Arena was the first to introduce cloud-based SaaS solutions for PLM and, later, QMS. These solutions were purpose-built to help manufacturers in high-tech electronics, medical device, and other electronics-heavy industries develop and deliver innovative products by streamlining new product development (NPD) and new product introduction (NPI) processes between their internal teams and supply chain partners. In addition, Arena PLM and QMS simplify compliance to environmental, safety, ISO, FDA , U.S. export controls (e.g., ITAR, EAR), and EMA regulations.
What sets Arena QMS apart from many other document-centric solutions is its product record foundation. Managing parts, bills of materials (BOMs), drawings, specifications, and documents together with quality records eliminates information silos. This product-centric QMS approach connects all quality records (e.g., CAPAs, SOPs, DMRs, DHFs) to the related product record—ensuring all teams are constantly working around the latest information at all times.
While PLM systems help engineering teams and design partners speed NPD, they also help downstream teams in quality, manufacturing, and the supply chain improve operational efficiencies to eliminate errors and reduce the cost of goods. Gartner’s definition of PLM emphasizes this point by defining PLM as a discipline that has grown from a mechanical design and engineering focus to being applied to many different vertical-industry product development challenges.iv
When companies look to justify their investment in cloud solutions like PLM or QMS, it’s important to understand the strategic benefits. Bringing people and product processes together anytime and anywhere around the world helps keep everyone on the same page. More importantly, it eliminates silos that lead to product design problems, quality issues, and production mistakes. These cloud solutions ultimately help mitigate risk and drive increased profits by helping companies deliver products on time and under budget.