Services
Our 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.
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