Product-Centric QMS: A Critical Advantage for Regulated Companies

Introduction

Quality systems for companies regulated by the Food and Drug Administration (FDA) must follow current good manufacturing practices (CGMPs) to comply with 21 CFR part 820 regulations¹. Furthermore, medical device companies must adhere to ISO 13485 and demonstrate their ability to meet customer and regulatory requirements. Together, the FDA and ISO requirements inform best practices for compliant quality management². In the past, medical device, biotechnology, and other regulated companies could choose only one type of quality management system (QMS) to simplify compliance—documentcentric ones. Today, you can choose between two types of QMS—the traditional document-centric or the product-centric QMS. What’s the difference and how do you make the best choice for your company?

In heavily regulated environments, the key to introducing safe and effective products is maintaining a tight connection between all of your product information, quality records, training plans, and audit processes. This can be difficult with dispersed teams and partners. To address quality compliance, you must manage the full product recording—including the complete bill of materials (BOM) with dynamic connections or links to the approved manufacturers’ list (AML), approved vendors’ list (AVL), regulatory and environmental compliance information, and engineering changes (ECOs)—along with all related quality issues and corrective actions. For life sciences companies, regulations also require establishing strong design controls and managing the design history file (DHF) and the device master record (DMR).