Quality Systems
Validation
Validation services include developing master plans, protocols, summary reports, as well as regulatory submissions. Here are some of the services Pacific BioDevelopment offers in this arena:
- Design Phase-appropriate validation strategies for new products, processes, and facilities
- Evaluate existing validation programs against current regulatory expectations and guidance documents and develop strategies to achieve compliance
- Benchmark against current industry practices for validation including risk-assessment and implementation of Quality by Design (QbD) concepts.
- Provide training and conduct mock audits in preparation for regulatory inspection
- Provide interim management and oversight for clients without internal staff
