Valicare specialises in GMP compliant CSV documentation based on GAMP 4 guidelines. We develop all relevant design specifications like Functional Specifications (FS) and Hardware Design Specifications (HDS). 

We then prepare the testing documents for Operational Qualification by Control Tests (OQ-CT) including testing of machine interfaces, operator interfaces, software functions, alarm / fault testing, and user access security. 

Regulatory compliance for the storage and handling of process critical data, recipe parameter storage, and recipe parameter modification are evaluated and tested with respect to FDA requirements for “electronic records” (ER) and “electronic signatures” (ES), according to 21 CFR part 11.

Valicare CSV specialists have years of experience in equipment qualification and computer systems validation as well as the development and design of computer and automation systems for pharmaceutical manufacturing. Our design experience in the pharmaceutical and bio-tech industries enables us to provide rapid, specific and cost efficient solutions to your computer system validation, and accurately assess and recommend solutions where problems are found.