eQMS (electronic quality management system)

An eQMS is software that holds the quality processes — documents, training, audits, CAPA, suppliers and the records that connect them — so an auditor can follow one thread.

The letters do not guarantee ISO 13485. A shared drive with SOPs is electronic and is not a controlled system. What matters is approval, revision, training on the current version, and a trail from finding to action. HAVGATE is an eQMS for those workflows, with CRM and bookkeeping kept as separate modules.