Fully Validatable Designs
When it comes to validation, there is no winging it. To create documented verification that a process will produce the predefined specification, you have to know how to execute fully validated designs.
It is important to know in advance that what you describe will function as designed. There are plenty of details to cover. Validation impacts practically every area and phase of an automation project for pharmaceutical and biotechnology companies.
With an industry experienced Quality team, we have been executing small and large scale projects for some of the area’s leading pharmaceutical and biotechnology companies during the last two decades. This has enabled Court Square Group to become validation experts. Our team has over 50 years of industry Quality experience.
As the requirements call for the creation of significant amounts of documentation, it also helps to know how early steps can make ongoing validation documentation easier to execute.
We base the engineering effort required to create validation protocols and documents on the GAMP™ guidelines, our validation experience and the clients’ method for validation. These documents incorporate the requirement, design, implementation, test, and verification process.
- User Requirement Specification
- Quality and Project Plan
- Functional Specification
- Design Specification
- Test Protocols
- Installation Qualification
- Performance Qualification
In addition we customize validation solutions to meet our clients needs.