For highly regulated industries like life sciences and pharma, industry-specific quality management systems (QMS) address the complex product development lifecycle of pharmaceutical, biotech, and medical devices products. Medical Quality Management Systems (QMS) are designed to facilitate compliance with regulations enacted by the FDA and standards like ISO 13485 (the International Organization for Standardization specific to medical devices). Additionally, with a medical QMS, life science businesses can eliminate paper-based quality processes, improve product quality and safety, reduce overall costs, increase operational efficiency, and unify and standardize processes, documentation, and communication.
If you are looking for a quality system that facilitates the standardization and maintenance of standard operating procedures (SOP) or internal business processes, take a look at the healthcare compliance software. Additionally, some horizontal quality management software solutions can be, and are, used for less complicated quality processes for pharmaceutical, biotech, and medical device products.
To qualify for inclusion in the Medical Quality Management Systems (QMS) category, a product must:
Provide product traceability functionality
Track and document every event and process that occurs during the product lifecycle
Monitor industry regulation and set up reminders or triggers for potential violations
Capture customer complains to assess and manage risk
Facilitate product testing and inspections
Provide support and workflows for corrective actions to tested products
