Qualification
- Production equipment / HVAC system / Laboratory equipment
- Risk analysis and project management
- Writing, execution, and approval of qualification protocols and reports
- URS / FAT / SAT / IQ / OQ / PQ
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Process and Method Validation
- Definition of validation strategy and risk analysis
- Industrial transfer
- Development, execution, and approval of validation protocols and reports
- Holding time
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Cleaning Validation
- Definition of validation strategy and risk analysis
- Development, execution, and approval of cleaning validation protocols and reports
- Matrix development / Worst-case definition and validation
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Validation of computerised – Automated systems – Data integrity
- Qualification of software and automated equipment / Audit trail
- Compliance with regulations (21 CFR Part 11, GAMP 5, etc.)
- Testing and validation of data management systems
- Securing and traceability of information
They trust us in consulting
Did
you
know ?
Our team prepared the GMED audit for ISO 13485 certification of a leading animal reproduction institute.
We qualified utilities and managed the technology transfer of a €5M project for a new pharmaceutical filling and packaging system.
We installed a DDU robot to automate quality control for an international research institute.
We wrote validation protocols and reports for automated systems for a multinational scientific company.
Our team managed the transfer and validation of analytical methods for a U.S. company preparing for commercialization in Europe.
We installed a fully automated final packaging line for a laboratory specializing in injectables (€4M project).
