Quality management built for your industry
QFacts is trusted by regulated companies across pharma, medical devices, healthcare, food, and ISO-certified organisations. Whatever your compliance requirements, we have you covered.
Trusted across regulated industries
Pharma & Biotech
Pharmaceutical and biotech companies face some of the most demanding quality and compliance requirements in any industry. From drug development through manufacturing and distribution, every process must meet strict GxP standards and withstand regulatory scrutiny.
- Document control for SOPs, batch records, and validation protocols
- Training management to ensure GMP competency across your workforce
- CAPA workflows for deviations, OOS results, and audit findings
- Audit-ready trails with electronic signatures and timestamped records
Medical Devices
Medical device manufacturers must maintain rigorous quality systems that satisfy both pre-market and post-market requirements. Whether you are working toward CE marking or FDA clearance, QFacts provides the structure your QMS needs.
- Design control documentation with traceability from requirements to verification
- Complaint handling and vigilance reporting with structured workflows
- Supplier qualification and ongoing management with audit scheduling
- Risk management documentation aligned with ISO 14971
Healthcare
Healthcare organisations, from clinical laboratories to hospitals, must demonstrate consistent quality and compliance with accreditation bodies. QFacts helps you manage the documentation, training, and continuous improvement that accreditors expect.
- Procedure management with controlled distribution and acknowledgement tracking
- Staff competency tracking with automated retraining reminders
- Incident reporting and root cause analysis with corrective action follow-up
- Accreditation preparation with document readiness dashboards
Food
Food safety management requires constant vigilance, from supplier qualification through production to distribution. QFacts gives food companies the tools to maintain HACCP plans, manage audits, and respond quickly to food safety events.
- Food safety documentation with version control and approval workflows
- Supplier audit scheduling, findings tracking, and corrective actions
- HACCP plan management with critical control point monitoring
- Corrective action tracking for internal and external audit findings
ISO-regulated Industries
Organisations certified to ISO management system standards need a structured approach to documentation, audits, and continual improvement. QFacts supports your management system regardless of which ISO standard you follow.
- Management system documentation with process-based organisation
- Internal and external audit preparation with finding tracking
- Continual improvement workflows tied to management review outputs
- Risk and opportunity registers with action tracking and review cycles