Quality Assurance and Validation

Sartorius Data Analytics quality assurance team works fulltime with testing and validation of our software products. All team members have attended GAMP 4 and 21 CFR Part 11 related training.

The test phase includes testing of new functionality, graphical and numerical regression testing and robustness testing. Bugs found during testing are addressed by the development team. The test phase is complete when all scheduled tests have been run, and re-run as required, and the software conforms to the quality goals. The test period is usually 3-12 months, depending on the software.

The validation phase takes place after the code has been locked for changes. Validation of the offline software includes validation of new functionality and graphical and numerical validation vs. the previous version or specification. The online software is validated vs. the current version of the corresponding offline software. Validation documentation is assembled in a validation package with a summarizing validation report. The validation is then approved and signed by the Managing Director before it is made publicly available. Backups of the software source code and all original validation documents are stored securely by a third party.