GMP compliance without the paper trail. One platform.
Batch records, CAPA management, and document control spread across validated spreadsheets and legacy systems. Q-Hub is FDA 21 CFR Part 11 compliant out of the box — electronic signatures, audit trails, and full traceability.
“FDA audit readiness went from a quarterly panic to a daily dashboard.”
Head of Quality, BMC Analysis
Sound familiar?
Validation consumes months of effort
Every new system requires IQ/OQ/PQ protocols, traceability matrices, and risk assessments. By the time validation is complete, the business has already moved on to the next compliance fire.
Change control drowns in paper
Change requests are routed via email, impact assessments live in Word documents, and approval signatures are collected on wet-ink forms. A single change can take weeks to close when it should take days.
Audit trail gaps risk regulatory findings
When the MHRA or FDA inspector asks who accessed a document, when it was modified, and why — the answer should be instant. Instead, your QA team spends hours piecing together evidence from multiple systems.
The numbers from our pharma customers
Based on average results from Q-Hub pharma customers. Individual results may vary. Read customer stories
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.
Your Data Is Safe With Us
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Used across regulated industries
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.
One validated platform for pharmaceutical quality management
Validated Document Control
SOPs, batch records, and quality manuals — version controlled with multi-level approval workflows and electronic signatures. Every document action is captured in an immutable audit trail. FDA 21 CFR Part 11 and EU GMP Annex 11 compliant out of the box.
GxP Audits & Inspection Readiness
Schedule and conduct internal GMP audits, supplier qualification audits, and regulatory inspection preparation reviews. Findings generate CAPA automatically. Complete audit history with evidence attachments provides inspection-ready documentation at the click of a button.
Change Control & Deviation Management
Manage the full change control lifecycle — request, impact assessment, approval, implementation, and effectiveness review. Deviations are logged with root cause analysis and linked CAPA. Every step is electronically signed and audit-trailed for regulatory confidence.
Built for pharmaceutical regulations
FDA 21 CFR Part 11
Electronic records and signatures compliance
EU GMP Annex 11
Computerised systems validation
ISO 13485
Medical devices quality management
ICH Q10
Pharmaceutical quality system guidelines
GAMP 5
Good Automated Manufacturing Practice
MHRA
UK Medicines and Healthcare products compliance
Q-Hub vs paper-based QMS and legacy eQMS
| Feature | Paper + Legacy eQMS | Q-Hub |
|---|---|---|
| Industry-specific templates | ✗ | ✓ |
| Regulatory compliance tracking | Manual | ✓ |
| Mobile inspections & audits | ✗ | ✓ |
| Automated CAPA workflows | ✗ | ✓ |
| Real-time compliance dashboards | ✗ | ✓ |
| Multi-site management | ✗ | ✓ |
| Integration with existing tools | Limited | ✓ |
| Complete audit trail | Manual | ✓ |
Pharmaceutical resources
Based on 60% time reduction. Actual savings depend on current processes.
Pharmaceutical compliance FAQs
Yes. Q-Hub provides compliant electronic signatures with user authentication, signature meaning capture (approved, reviewed, rejected), and tamper-evident audit trails. Every signature is linked to the signer's identity, timestamp, and the exact document version — meeting both FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
Q-Hub is delivered with a comprehensive validation package including IQ/OQ protocols, requirement traceability matrices, and risk assessments aligned to GAMP 5. Our validation documentation reduces your CSV burden significantly — most pharma customers complete validation within 2–3 weeks.
Absolutely. Q-Hub's change control module handles the full lifecycle — from change request through impact assessment, approval, implementation, and effectiveness review. Deviations are logged with root cause analysis, linked CAPA, and automatic escalation rules. Every step maintains a complete audit trail.
Every action in Q-Hub is recorded in an immutable audit trail — document views, edits, approvals, rejections, and electronic signatures. Audit trails are timestamped, cannot be modified or deleted, and can be exported for regulatory inspection. This meets FDA 21 CFR Part 11 and EU GMP Annex 11 audit trail requirements.
Most pharmaceutical customers are live within 4–6 weeks including validation. Our implementation team handles data migration, system configuration, validation support, user training, and go-live. Complex multi-site deployments with extensive validation requirements may take 8–12 weeks.
Every Q-Hub plan includes onboarding training, a dedicated customer success manager, email and phone support during UK business hours, and access to our help centre with 50+ articles and video tutorials. Enterprise plans include priority support with a 2-hour SLA.
Q-Hub starts from £85/month for small teams (Starter plan). Our Essentials and Pro plans include more modules and users. Enterprise pricing is bespoke. All plans include implementation support, training, and a dedicated customer success manager.
Yes. We offer a 14-day free trial with full access to all modules -- no credit card required. Most teams see value within the first week. If you'd prefer a guided experience, book a personalised demo and our team will set up your trial with your own data.
Our implementation team handles data migration as part of every plan. We'll import your existing documents, audit records, training data, and NCR history. Most migrations complete within the 4-week implementation window. Your data remains yours -- you can export it at any time in standard formats.