GxP Compliance Services
Our GxP Compliance Services
Practical compliance support covering the full spectrum of pharmaceutical storage and distribution requirements — from initial system validation through to ongoing monitoring and data analytics.
The work we do is more than just ticking regulatory boxes. We build understanding, we instil confidence, and we create systems that keep working long after an audit is complete. By listening to your compliance story and deeply understanding your needs, we support you while you help get life-saving medication to those in need. A detailed consultation and gap assessment, followed by a thorough Risk Analysis, defines your User Requirements Specification and sets a timeline to suit your utility schedule.
Validation
Systematic, evidence-based validation of temperature monitoring systems, building management systems, data integrity controls, and electronic records.
Key Outputs
- Validation Master Plans (VMP)
- Validation Protocols
- Traceability Matrices
- Test Scripts
- Validation Summary Reports
Qualification
IQ, OQ, and PQ qualification for cold rooms, refrigerators, freezers, warehouses, environmental chambers, transport vehicles, and packaging systems.
Key Outputs
- Installation Qualification (IQ) Protocols
- Operational Qualification (OQ) Protocols
- Performance Qualification (PQ) Protocols
- Qualification Summary Reports
- Change Control Documentation
Thermal Mapping
Temperature distribution studies for pharmaceutical storage environments. Full scope from protocol development to data analysis and summary reporting.
Key Outputs
- Mapping Protocols
- Sensor Placement Plans
- Raw Data Review Reports
- Statistical Analysis
- Thermal Mapping Summary Reports
GxP Training & Advisory
Practical training for operational and technical teams. Courses tailored to your environment, regulatory framework, and team's existing knowledge base.
Key Outputs
- Training Materials
- Attendance Records
- Competency Assessments
- Training Plans
- Advisory Reports
GxP Documentation
Inspection-ready documentation covering the full compliance lifecycle — from system design through to CAPA-linked remediation records.
Key Outputs
- Validation Master Plans
- URS / FDS / SDS
- SOPs
- Risk Assessments
- CAPA Documentation
- Traceability Matrices
Reporting & Data Analytics
Turn your monitoring and validation data into operational and compliance insight. Dashboards, excursion analysis, trend review, and management reporting.
Key Outputs
- Compliance Dashboards
- Excursion Analysis Reports
- KPI Summary Reports
- Trend Review Reports
- Management Reporting Packs
Not sure where to start?
Get in touch and we can help you identify the right compliance starting point for your organisation.
Request a Consultation