Quality Management Software · QMS · eQMS
Quality management software for regulated companies that have outgrown paper and SharePoint.
Document control, CAPA, audits, supplier quality, training and deviations in one system, linked to the work they describe, with people reviewing and signing each decision.
Document control
CAPA + nonconformance
Internal + supplier audits
Training matrix + competence
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping for QMS software because audit prep has become a department.
Document control is SharePoint, OneDrive, and a shared mailbox
CAPA effectiveness checks are tracked in Excel and nothing else
Training records are PDFs of signed sheets in a network folder
Last audit had findings on document hierarchy, audit trail, and CAPA closure
Your QMS vendor wants $250k/yr and a six-month implementation
Every QMS process modeled, configured, and connected.
Document control
Effective dating, periodic review, controlled distribution, training-link enforcement. Replaces SharePoint and the shared mailbox entirely.
CAPA + nonconformance
Root-cause workflows (5-whys, fishbone), effectiveness checks scheduled at closure, links to deviations and audits.
Internal + supplier audits
Schedule, plan, execute, evidence — including third-party supplier audits — with full finding-and-CAPA lineage.
Training matrix + competence
Role-based curricula, training-on-revision, competence assessment, supervisor sign-off.
Hash-chained audit trail
Every event on every record, immutable. Inspectors can verify nothing was edited or backdated.
QMS wins compound — cleaner data, faster decisions, smaller QA team.
- Supplier qualification lapse rate drops to zero with automated reminders
- Replaces $250k/yr legacy eQMS at a fraction of the cost
Aligned with every standard your auditor cares about.
ISO 9001:2015
Document control (7.5), competence (7.2), nonconformity & CAPA (10.2), internal audit (9.2), management review (9.3) — all modeled, all evidenced.
ISO 13485:2016
Design controls, DHF/DHR/DMR, risk management hooks (14971), CAPA, post-market — same engine, device-grade controls.
21 CFR Part 820 / Part 211
QSR and drug cGMP modeled directly — document control, design controls, production records, complaint handling, CAPA.
Building medical devices? See the device history record page.
Quality management software, answered.
What is a quality management software (QMS)?
Quality management software (QMS / eQMS) is the system of record for documents, training, CAPA, audits, suppliers, deviations, and change control in a regulated company. It replaces the SharePoint-plus-Excel-plus-paper stack with one inspectable, audit-trailed platform.
Does V5 cover ISO 13485 and FDA QMSR?
Yes. Document control, design controls, DHF/DHR/DMR, risk hooks (ISO 14971), CAPA, post-market — all modeled. V5 is already aligned with the harmonized FDA QMSR final rule effective February 2026.
Can we migrate from our current QMS?
Yes. Document libraries, CAPA history, training records, audit findings — all moved with integrity.
How long is implementation?
Timelines depend on scope — sites, lines, integrations and validation — and are set in your Order or Statement of Work. There is no standard number of weeks.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.