Effective Nonconformance Management Key to FDA and ISO Compliance

About this Document

FDA regulations and ISO standards exist to keep products safe, reliable and of high quality. When a product or its component parts are nonconforming to specifications, they must be handled efficiently and according to both FDA and ISO requirements. This white paper outlines the most prominent regulations and standards that address nonconformance disposition, and the many ways an automated software system can help solve the challenges in handling material nonconformances.