Quality process: CAPA
It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical: the automation of CAPA processes. When implemented properly, a Corrective Action (CAPA) software system improves product quality and safety, increases customer satisfaction, and more importantly, ensures FDA and ISO compliance.
Quality process: Change control
Quality Management Sytems (QMS) ensure change management processes in regulated environments and assure enhancement in productivity. In FDA-regulated and ISO-certified environments, companies are expected to establish procedures for effective change control software systems in order to ensure product quality and safety. Regulated and ISO companies are also expected to maintain detailed documentation on all changes that are made in a change control software.