The validation of equipment within the pharmaceutical industry is very challenging, this is due to the pharmaceutical processing equipment, such as moist heat sterilizers, freeze dryers and depyrogenation tunnels, require more than just high accuracy and reliability. They also require detailed documentation and traceability. Furthermore, it is important that the validation system is fully compliant with the relevant requirements and guidelines, such as FDA 21 CFR 11 Part 11 and GAMP4 for the validation of automated Systems in Pharmaceutical Manufacture.
These requirements need to be met before the measuring results can be approved and accepted by FDA/USDA and other regulatory authorities. An important part of the validation, is documentation as well as reporting exactly why the ValSuite™ Pro software facilities play a major role in analysis and execution. The easy and fully automatic execution of validation equipment calibrations are an integrated and essential part of the process, and is therefore embedded in the ValSuite™ software.
In the individual application descriptions shown below, important information regarding Processes, Challenges, Guidelines and Methods can be found.