System qualification

In the regulated GMP environment, we create the required qualification documents based on the FDS and E-planning. Thanks to our risk-based approach, we generate around 80 % of the GMP-relevant documentation during the software FAT, which significantly speeds up and simplifies the process.

After start-up, these documents are enriched with the SAT data (Site Acceptance Test) to ensure complete and seamless documentation. This ensures that all regulatory requirements are met efficiently and that your systems are commissioned quickly and safely.