Electronic Quality Management System · eQMS · GxP
eQMS software for regulated manufacturers outgrowing spreadsheets.
Document control, CAPA, deviations, change control, training and audits in one platform, with a rollout plan agreed with you.
Document control
Training + Competence
Signed Audit Trail
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're evaluating an eQMS because paper SOPs and shared drives just failed an audit.
CAPAs sit in Excel with no owner, no clock, no escalation
Training records live in HR, in the LMS, and on a wall — none reconcile
Supplier scorecards are quarterly PDFs, not live signals
Auditors ask for the audit trail and you screenshot a table
Every eQMS module a regulated site needs — configured, not custom-built.
Document control
Versioned SOPs, work instructions, forms, and specs with periodic-review timers and read-and-understood signatures bound to training.
Training + Competence
Role-based curricula, revision-triggered retraining, LMS interop, ISO 13485 §7.2 evidence pack on demand.
Signed Audit Trail
Hash-chained, tamper-evident, Part 11 §11.10(e) compliant — export a full attribution package for any inspector.
Why an eQMS pays for itself in the first year.
- Change-control lead time cut from weeks to days
- Training compliance visible per person, per SOP, per shift — in real time
- One inspection dossier — not seven binders and a scramble
eQMS aligned with every regime your site is inspected under.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — software controls that support your Annex 11 approach; validation and procedures remain yours.
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.
eQMS software, answered.
What is eQMS software?
An electronic Quality Management System (eQMS) is the system of record for a manufacturer's quality processes — document control, CAPA, deviations, change control, training, supplier quality and audits — running under 21 CFR Part 11 / EU GMP Annex 11 controls.
eQMS vs QMS — is there a difference?
Every modern regulated QMS is an eQMS.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.