Pharmaceutical Manufacturing
QMS Pharma
Quality today. Compliance always. Better tomorrow.
A closed-loop quality management system connecting deviations, CAPA, change control, audits, complaints, risk, and training — the same depth of quality event management enterprise eQMS platforms offer, built for regional pharmaceutical manufacturers.
- FDA 21 CFR Part 11
- EU Annex 11
- WHO GMP
- PIC/S GMP
- ICH Q10
- GxP
Core Modules
One connected system for every quality process — instead of a dozen disconnected spreadsheets and shared folders.
Quality Event Management
Deviation Management
Log, investigate, and close deviations with structured root-cause analysis and full traceability back to the originating event.
CAPA Management
Closed-loop corrective and preventive actions that can be launched directly from a deviation, complaint, audit finding, or nonconformance.
Nonconformance Management
Identify, evaluate, and disposition nonconforming materials and products, with automatic escalation to CAPA when warranted.
Change Control
Route change requests through configurable, GMP-aligned approval workflows with documented impact assessment.
Documentation & Training
Document Control
Version-controlled SOPs, policies, and records with configurable authoring, review, and approval workflows.
Training Management
Whenever a linked SOP changes, affected employees automatically receive a new training task — training-on-change, built in.
Supplier & Vendor Quality
Track supplier qualification, audits, and quality performance history alongside your internal quality data.
Risk & Audit
Quality Risk Management
Apply a structured, ICH Q9-aligned risk methodology to change control, deviations, and supplier decisions.
Audit Management
Plan internal and external audits, track findings, and manage responses through to verified closure.
Complaint Handling
Capture, investigate, and trend customer and market complaints in line with regulatory expectations.
Compliance & Reporting
Electronic Signatures & Audit Trail
Attributable, time-stamped e-signatures and a complete, exportable audit trail on every quality record.
Configurable Workflows
No-code workflow and form configuration so your quality processes match how your organization actually operates.
Quality Dashboards & Trend Analytics
Live KPIs on open CAPAs, overdue actions, deviation trends, and audit findings for management review.
Ready For Compliance
Why CoreMind Vision
Enterprise-grade capability, without the enterprise-only price tag or year-long rollout.
Closed-Loop by Design
Deviations, complaints, audits, and nonconformances all connect to CAPA natively — nothing falls through the cracks between systems.
Training-on-Change, Built In
Update an SOP and affected staff are automatically assigned retraining — a feature usually reserved for the largest eQMS suites.
Fast, Guided Implementation
Pre-configured GMP workflows mean go-live in weeks, not the multi-quarter rollouts typical of global enterprise QMS platforms.
Sized for Regional Manufacturers
The same closed-loop quality event management larger multinational platforms offer, priced and supported for mid-size operations.
One Quality System, Every Regulatory Framework
QMS Pharma replaces scattered spreadsheets and paper trails with a connected quality management system that quality managers, QA reviewers, and inspectors can all trust.
- Close the loop on deviations and CAPAs with automated escalation and reminders
- Cut audit preparation time with instantly exportable, timestamped records
- Keep every SOP and controlled document under version control
- Trend complaints and deviations to catch systemic issues earlier
- Give leadership a live view of quality KPIs across every site
QMS Pharma FAQ
Yes. CAPAs can be initiated directly from deviations, complaints, audit findings, or nonconformances, carrying relevant data forward automatically to reduce re-entry and errors.
Yes. When a document linked to a training course changes, every affected employee automatically receives a new training task and notification.
Yes, the risk management module follows an ICH Q9-aligned methodology that can be applied to change control, deviations, and supplier decisions.
Yes — all three CoreMind Vision pharmaceutical products share a common data model, so events like a calibration out-of-tolerance or a failed artwork inspection can flow directly into a QMS Pharma deviation.