Validation and Qualification
Our pharmaceutical group extends traditional construction management services to pharmaceutical and biotech clients by assisting in the commissioning, qualification and validation of their facilities. Our regulatory and good practice know-how, combined with our risk management experience, helps clients achieve the most cost-effective compliance. We excel in project execution and serve as a strategic partner in qualifying your facility.
Pharma-Tech’s validation team provides a broad range of services from system and component level impact assessments to validation master planning and staff augmentation. We can work with you to develop validation master plans to best utilize and leverage successful commissioning activities into your validation strategies. We work closely with each client to provide the desired level of detail and content to be written within their validation documents. We have an extensive library of Validation and Qualification templates and procedures that allow us to quickly apply our test procedures to your project. This greatly minimizes document development time and allows for quicker document review and approval.
Our success stems from our ability to help our clients define appropriate functional and performance specifications for which the equipment is tested. Errors during the functional specification review phase will have a tremendous impact on the efficiency of your validation project execution. It is imperative to catch errors on paper early during the design phase rather than construction or qualification phases.
Our Validation & Qualification Services include
- Validation Project and Master Planning
- Criticality & Impact Assessments
- Protocol Writing and Execution
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Factory and Site Acceptance Testing
- Summary Reports
- GMP Documentation
- Quality Assurance Planning
- Change Control
- FAT & SAT Testing
- Process Validation
- Cleaning and Sterilization Validation
- Temperature Mapping – Kaye Validator 2000/Biological Indicators
- Kaye Validator Rental
- DeltaV Computer Software Validation
- Material Verification
- I/O Testing
- Alarms and Security Testing
- Control Loop Testing
- Requalification
- Riboflavin Coverage Testing
- Validation Procedures Training
- 21 CFR Part 11
- GAMP V
- ASTEM E 2500
- Detailed Design Specifications
- Functional Specifications
- User Requirements Specifications
- C&Q Leverage strategies
- Process Development
- Leveraging of Process Analytical Technology