• Best 21 CFR Part 11 compliant QMS software: No software is Part 11 compliant on its own. Here is what each QMS gives you towards it: signatures, audit trails and validation evidence.
• Best CAPA software for medical devices: Which QMS systems handle corrective action and nonconforming product well, judged by their documentation rather than their marketing pages.
• Best design control software for medical devices: Design controls, risk management and the software lifecycle, ranked by whether requirements, risks and tests are linked records or a folder of documents.
• Best document control software for medical devices: Every QMS we reviewed controls documents. They differ in where you write them, how training follows a new revision, and whether your records leave with you.