Quality management software that closes inspections instead of opening them.
Document control, CAPA, audits, supplier quality, training, deviations, change control — all in one system, all hash-chained, all inspector-ready. V5 Ultimate is the QMS regulated companies pick when SharePoint, paper, and three half-built apps have stopped working.
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
Supplier requalifications are 14 months overdue and nobody knows
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.
Change control
Cross-functional review, risk assessment, impact analysis, implementation gate, post-implementation review.
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.
- Cuts audit prep from 3 weeks to 2 days
- Eliminates document-control SharePoint sprawl in one quarter
- CAPA effectiveness check rate goes from 'occasional' to 100%
- 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.
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.
How is V5 different from MasterControl, Veeva Vault QMS, or Qualio?
V5 ships pre-configured, integrates with ERP and LIMS out of the box, runs the eBR / MES on the same platform (not a separate purchase), and is priced for plants that aren't on a $1M software budget. See our comparison pages for specifics.
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. We've migrated from MasterControl, Veeva Vault QMS, Qualio, Greenlight Guru, ETQ, and TrackWise. Document libraries, CAPA history, training records, audit findings — all moved with integrity.
How long is implementation?
Typical QMS implementations run 8–12 weeks for a single site. Multi-site rollouts add 4–6 weeks. We do not run multi-year implementation programs.