eQMS Software for Regulated Industries
FDA 21 CFR Part 11 compliant electronic quality management with electronic signatures, tamper-proof audit trails, and pre-built GxP validation documentation. Replace paper-based quality systems in weeks, not months.
Purpose-Built for Regulated Industries
Click any capability to explore how it supports your compliance requirements.
Electronic Signatures
21 CFR Part 11 compliant e-signatures with meaning codes, multi-factor authentication, and non-repudiation.
Learn moreComplete Audit Trails
Every action, login, and data change logged with user identity, timestamp, and reason. Tamper-proof and permanent.
Learn moreDocument Control
Version-controlled SOPs with review cycles, approval routing, and controlled distribution. No unapproved documents in circulation.
Learn moreCAPA Management
Root cause analysis, effectiveness verification, and escalation workflows. Link CAPAs to deviations, complaints, and audit findings.
Learn moreDeviation Management
Structured deviation reports with impact assessment, root cause investigation, and CAPA linkage. Automatic regulatory classification.
Learn moreChange Control
Impact assessment, cross-functional review, regulatory classification, and implementation tracking with full traceability.
Learn moreThe Quality Event Lifecycle
From detection to closure — click each stage to learn more.
Detect the Quality Event
Capture deviations, complaints, OOS results, and non-conformances through structured forms. Automatic classification by severity and regulatory impact. Electronic notifications to all affected parties within minutes.
Capture deviations, complaints, OOS results, and non-conformances through structured forms. Automatic classification by severity and regulatory impact. Electronic notifications to all affected parties within minutes.
Investigate Root Cause
Guided investigation workflows with built-in 5 Whys, Ishikawa diagrams, and fishbone analysis. Attach evidence, interview notes, and lab data. Link related events for pattern detection across your quality system.
Guided investigation workflows with built-in 5 Whys, Ishikawa diagrams, and fishbone analysis. Attach evidence, interview notes, and lab data. Link related events for pattern detection across your quality system.
Implement Corrective Actions
Generate CAPAs directly from investigations. Assign owners, set deadlines, and track implementation tasks. Cross-functional review ensures all impacts are addressed. Electronic signatures capture formal approval.
Generate CAPAs directly from investigations. Assign owners, set deadlines, and track implementation tasks. Cross-functional review ensures all impacts are addressed. Electronic signatures capture formal approval.
Verify Effectiveness
Scheduled effectiveness checks ensure corrective actions actually work. Evidence-based verification with documented outcomes. Reopen CAPAs automatically if effectiveness criteria are not met.
Scheduled effectiveness checks ensure corrective actions actually work. Evidence-based verification with documented outcomes. Reopen CAPAs automatically if effectiveness criteria are not met.
Close & Trend
Formal closure with electronic signature. Feed data into trend analysis and management review. Identify recurring issues before they become systemic. Complete audit trail maintained permanently for regulatory inspections.
Watch the 3-Minute eQMS Demo
See how Q-Hub eQMS handles electronic signatures, document control, and CAPA management in a regulated environment.
Electronic Records That Regulators Trust
Purpose-built for FDA 21 CFR Part 11 and EU Annex 11 compliance. Every electronic record includes tamper-proof audit trails, timestamped entries, and cryptographic integrity verification. No more paper-based workarounds or warning letters.
See Every Screen Before You Commit
Explore the five key areas of Q-Hub eQMS. Click a tab or let it auto-advance.
Schedule, conduct, and track audits with automated CAPA generation
Stop Managing Quality on Paper
| Feature | Paper / Spreadsheets | Legacy QMS | Q-Hub |
|---|---|---|---|
| Digital workflows | Manual | ✗ | ✓ |
| Real-time dashboards | ✗ | ✗ | ✓ |
| Mobile access | Limited | ✗ | ✓ |
| Automated notifications | ✗ | ✗ | ✓ |
| Complete audit trail | ✗ | ✗ | ✓ |
| Role-based permissions | Basic | ✗ | ✓ |
| Custom reporting | Manual | ✗ | ✓ |
| Multi-site support | ✗ | ✗ | ✓ |
| Integration with other tools | ✗ | ✗ | ✓ |
| ISO compliance ready | ✗ | ✗ | ✓ |
Calculate Your Compliance Time Savings
Enter your current quality workload to see how much Q-Hub eQMS could save.
Based on 60% time reduction. Actual savings depend on current processes.
Trusted by compliance teams worldwide
“Qhub provides a visible, intuitive way to manage data and workflows, revolutionising our approach to operations”
Fowlers of Bristol (Engineers) Ltd
Operations director
“Qhub helps us to... proactively use our QMS... and increase efficiency”
Anglia Cathodic Protection Services
Business manager
“Really made a difference with providing compliance during audits – both regulatory, customer, and internal.”
Auxitrol Weston
Quality manager
“QHub has supported us in achieving a higher compliance rate.”
BMC Analysis
Technical Manager/ Quality Manage
“We can't believe how fast we were able to get it up and running.”
Cawood Group
“Managing NCRs are now so much easier”
Enviromesh
Quality manager
“Where was this 2 years ago... we're blown away”
Jaltek
Compliance manager for Jaltek
“Qhub has improved our safety management system no end, making it very efficient”
Rocal Endurance Doors
Compliance manager
“We use it for as much as possible.”
Scottish Leather Group
Compliance manager
Validated and Live in 6 Weeks
A structured rollout with dedicated validation support at every stage. Click each milestone to see what happens.
- Dedicated implementation manager with GxP experience assigned
- Organisation structure, sites, departments, and user roles configured
- Workflow design: approval routes, escalation rules, notification templates
- SSO integration and access control policies established
- Existing SOPs, policies, and controlled documents migrated with full version history
- Open CAPAs, deviations, and change controls transferred
- Training records and competency matrices imported
- Data validation and integrity checks completed with documented evidence
- Execute pre-built IQ protocol: verify installation and infrastructure
- Execute OQ protocol: verify configured workflows and access controls
- Execute PQ protocol: verify system performs as intended in production
- Complete traceability matrix and validation summary report
- Supervised go-live with your implementation manager on-hand
- User training: admins, quality team, document owners, approvers
- 30-day hypercare period with priority support
- Ongoing UK-based support via chat, email, and phone
How Q-Hub compares to other QHSE software
Feature-by-feature comparison with leading quality, safety, and compliance platforms.
| Feature | EcoOnline | SafetyCulture | Qualio | Intelex | Ideagen | Q-Hub |
|---|---|---|---|---|---|---|
| Integrated QHSE platform | Limited | ✗ | ✗ | Limited | Limited | ✓ |
| Document control with e-signatures | ✗ | ✗ | ✓ | Limited | ✓ | ✓ |
| Audit & inspection management | Limited | ✓ | Limited | ✓ | ✓ | ✓ |
| CAPA & NCR workflows | Limited | ✗ | ✓ | ✓ | ✓ | ✓ |
| Incident reporting & RIDDOR | ✓ | ✓ | ✗ | ✓ | Limited | ✓ |
| Risk assessment builder | ✓ | Limited | ✗ | ✓ | Limited | ✓ |
| Training & competence tracking | Limited | ✗ | ✗ | Limited | ✗ | ✓ |
| Permit to work | ✗ | ✗ | ✗ | Limited | ✗ | ✓ |
| Custom form builder | Limited | ✓ | Limited | ✓ | ✓ | ✓ |
| Supplier management | ✗ | ✗ | Limited | Limited | Limited | ✓ |
| Mobile offline inspections | ✓ | ✓ | ✗ | Limited | Limited | ✓ |
| Management review module | ✗ | ✗ | ✗ | Limited | Limited | ✓ |
| ROI calculator | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ |
| UK data hosting | Limited | ✗ | ✗ | ✗ | Limited | ✓ |
| UK-based support team | Limited | ✗ | ✗ | ✗ | ✓ | ✓ |
| Transparent pricing (no hidden fees) | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ |
| Free 14-day trial | ✗ | ✓ | ✓ | ✗ | ✗ | ✓ |
| Live in under 4 weeks | ✗ | ✗ | ✗ | ✗ | ✗ | ✓ |
Your Data Is Safe With Us
Hover to learn about each certification and commitment.
Connects with the tools you already use
Q-Hub integrates with your existing ecosystem via REST API, webhooks, and pre-built connectors. Edit documents in your preferred tools — Q-Hub handles the rest.
Used across regulated industries
Deepen Your eQMS Expertise
Free guides, whitepapers, and webinars for regulated quality teams.
eQMS Software Questions
Yes. Q-Hub eQMS is designed from the ground up for Part 11 compliance, including electronic signatures with meaning codes, tamper-proof audit trails, system access controls, and data integrity safeguards. We provide pre-built validation documentation including IQ/OQ/PQ protocols.
An eQMS adds regulatory-grade electronic records, electronic signatures, validation documentation, and full audit trails on top of standard QMS features. It is designed for FDA, EMA, and MHRA regulated industries such as pharmaceuticals, medical devices, and biotechnology.
Yes. Q-Hub includes pre-built IQ/OQ/PQ protocols, validation plans, traceability matrices, and risk assessments. Most customers complete computer system validation in weeks rather than months.
Most regulated companies go live in 4-6 weeks, including validation. Q-Hub provides a dedicated implementation manager, pre-built validation packages, and structured onboarding to accelerate deployment.
Yes. Q-Hub eQMS is designed for both FDA 21 CFR Part 11 and EU Annex 11 compliance. Features include electronic records integrity, validated system controls, and comprehensive audit trails that satisfy both regulatory frameworks.
Plans start from £149/month for regulated environments. All plans include a 14-day free trial with full access to eQMS features including electronic signatures and audit trails. See pricing →
Works Seamlessly With
Quality ManagementISO 9001 compliance and CAPA management. Document ManagementControlled documents and approval workflows. Training ManagementCompetency tracking and SOP training records.
Book a personalised demo
See how Q-Hub fits your team. Our specialists will walk you through the platform, answer your questions, and show you exactly how it works for your industry.
Pre-Built Validation Saves Months of Work
IQ/OQ/PQ documentation, validation protocols, traceability matrices, and risk assessments included out of the box. Reduce your computer system validation effort from months to weeks while maintaining full regulatory compliance.