From the start of validation planning through the final report and FDA approval, you need a team you can count on for expertise and performance. Your validation partner must be able to combine proper documentation, objective quality assurance, initiative, dedication, and good project management to achieve both regulatory compliance and business success. We develop validation master plans and protocols (IQ/OQ/PQ), perform field inspections, conduct testing and generate final reports. We have a strong reputation for determining the appropriate level of inspection or testing needed to achieve the high degree of assurance required by the FDA and other regulatory agencies.
We have performed hundreds of validation projects for dozens of clients. We have experience with equipment qualification, computer validation, cleaning validation, sterilization validation, laboratory instruments qualification, methods validation, and process validation. We understand how to leverage the quality assurance activities of vendors, factory acceptance tests, construction quality assurance, and commissioning activities to avoid duplication and streamline the final validation inspections and tests. This shortens the final stages of project delivery, when just about everything is on the critical path.
The result: Faster time to market for your product!
Major Facility Commissioning and Validation Services Inlcude:
- Commissioning and validation planning
- Commissioning project management
- Factory acceptance testing
- Commissioning procedures, inspection and test forms
- Equipment and system installation inspections
- Start-up and troubleshooting
- Commissioning testing
- Validation protocol writing
- Protocol field execution and reports
- Computer validation
- Cleaning validation
- Sterilization validation
- Process simulation
- Product validation
