Expertise
Validation & Qualification
Validation should demonstrate control, not generate paper. We support validation programs from master planning through execution and lifecycle maintenance, with documentation that stands up to review years after the protocol was signed.
Validation and qualification services
- Validation master plans and risk-based validation strategy
- Process validation Stage 1 design, Stage 2 qualification and Stage 3 continued process verification
- Cleaning validation strategy, limits rationale, recovery studies and cleaning verification
- Equipment and utility qualification: commissioning, IQ, OQ, PQ
- Facility and utility qualification including water systems, HVAC and compressed gases
- Analytical method validation and transfer support
- Computer system validation, Part 11 controls and periodic review
- Requalification, change-driven revalidation and legacy validation remediation
Legacy and inherited validation packages
Acquired sites and long-running products often carry validation packages that no longer reflect the process being run. We assess what is defensible, what needs to be re-executed and what simply needs an accurate, current rationale — then we help you close the gap in a defined sequence rather than all at once.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.