QMS software for manufacturing that touches the floor — not just the office.
Most eQMS platforms stop at the document library. V5 ties CAPA, deviations, training and supplier quality to the batch being made right now — so quality events are raised at the step, by the operator, with the record attached.
You searched 'QMS software for manufacturing' because the office eQMS never reached the line.
Deviations written on paper at 2am and entered on Thursday
SOPs controlled in one system, executed from a printout in another
Training records that don't know which line the person works on
CAPA actions that never reach the shop floor procedure they were meant to fix
Supplier issues invisible until the material is already in the blender
Two vendors, two audit trails, two validation packages
Quality management wired into production.
Deviations raised at the step
The operator raises the deviation in the batch, at the moment, with the step, equipment, lot and signature already attached.
CAPA that closes the loop
Corrective actions can update the procedure, the check, or the training curriculum — and effectiveness is measured against recurrence.
Document control on the kiosk
The operator executes the current effective revision. Superseded documents are unavailable, not just marked.
Training tied to the task
Role and line-based curricula, retraining on revision, and qualification checked before the step is allowed to run.
Supplier quality with the lot
CoA capture, qualification status and supplier NCRs linked to the receipt and the batch that consumed it.
One audit trail
Quality and production events on the same hash-chained, append-only trail — one export, one validation package.
What changes when QMS and production share a system.
- Deviations are recorded in minutes, at the step, with the evidence attached
- Untrained operators cannot execute a step they aren't qualified for
- CAPA actions land in the procedure people actually follow
- Audit prep drops from weeks to hours — one system, one trail
- No reconciliation between the quality system and the batch record
Standards a manufacturing QMS has to satisfy.
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.
FDA QMSR (2026)
Aligned with the harmonized QSR/ISO 13485 final rule effective Feb 2026. Your QMS doesn't have to be re-architected — V5 is already there.
QMS software for manufacturing, answered.
How is this different from a generic eQMS?
A generic eQMS manages documents and quality records in the office. A manufacturing QMS also executes — deviations are raised inside the batch, training gates the step, and document revisions reach the kiosk. V5 is both, on one platform and one audit trail.
Do we need the MES modules to use the QMS?
No. The QMS runs standalone. But sites that turn on execution get the benefit of quality events being tied to the batch, equipment and operator automatically.
Which standards does it map to?
ISO 9001:2015, ISO 13485:2016, 21 CFR 210/211 and Part 820 / QMSR, plus 21 CFR Part 11 for electronic records and signatures. Food sites map to FSMA, HACCP and GFSI schemes.
Can it replace our existing document control system?
Yes, and most sites do — effective dating, periodic review, controlled distribution and training-on-revision are native. Legacy PDFs are migrated with their revision history intact.
Does it integrate with our ERP?
Yes. Items, BOMs, work orders, receipts and inventory transactions sync both ways, so quality holds are reflected in ERP stock status.
How long does implementation take?
Document control, deviations and training typically go live in 30 days. Full CAPA, supplier quality and multi-site rollout usually run 8–12 weeks.
Put the quality system where the work happens.
Free trial. eQMS and execution on one validated platform.