Are Your Validations Run Effectively and Efficiently Leaving You with Optimized Processes Along with Compliant Documentation?
The purpose of validation is to ensure that the output of your manufacturing processes reliably meet design requirements. With process validation cited by the FDA as one of the most frequent violations, a well-documented validation is a requisite of a compliant quality system
Utilizing our foundation in Quality and Regulatory along with our expertise in Applied Statistics and Operational Excellence, we deliver VALIDATION EXCELLENCE. Your processes will not only be in compliance but they will also be optimized to deliver the best, most efficient, output.
We have significant experience delivering jobs of all sizes from several small validation activities to the planning, management, and completion of all validation activities for the start-up of a $200MM+ state of the art manufacturing facility.
We will partner with you to:
- Design and develop a plan for all stages of your product/production life cycle
- Create and publish all necessary documentation (protocols and reports) MVPs, IQs, TMVs, OQs, PQs, PPQs, etc.
- Identify and lock in efficiencies with the plan to optimize your processes
- Execute and deliver on all validation activities
- Organize and package validation material
- Provide training as necessary or as requested