Validations
Validation is the cornerstone to the lifecycle of your products and manufacturing facility. Developed, executed and maintained correctly and pragmatically, it becomes a value-added system which establishes a firm foundation for ensuring product quality, safety, identity, strength, purity and efficacy. Our experience and expertise delivers to our clients the built-in quality practices which ultimately enables the facility processes, systems and people to perform in a continued state of control over the whole lifecycle.
We understand the current regulatory environment surrounding validation and validation support systems, having been leaders in successfully turning around sites under regulatory mandates.
Validation Services We Provide
Commissioning and Qualification
- Engineering change management programs
- Design Qualification process
- Requirements Definition – we believe by integrating the proper User, Process and Product and GMP elements into the design, it prevents unnecessary downstream testing and creates a more meaningful change management process for future operations
- Master Plan and Project Plan development
- Critical Aspect Risk Assessments
- Vendor/Service Provider Quality Assessments
- Protocols, Reports, Validation Master Plans and Project Plans
Process and Cleaning Validation
- We design comprehensive studies with industry accepted sampling plans and practices.
- All opportunities for matrixing and streamlining are taken while maintaining a compliant approach.
- Ensure the processes have been fully proven and are repeatable, resulting in consistent products of high quality, safety, identity, strength, purity and efficacy.
- Smoother, more contained regulatory interactions are realized since all the information and data are included in the studies.
Computerized Systems Validation
- We ensure good data integrity practices across the board based on industry standard and recent regulatory actions related to Data Governance programs
- Adherence to 21CFR Part 11
- Pragmatic, yet compliant testing protocols, based on risk