A properly tested and qualified software system can give you, and the regulators, confidence in the integrity of your data. Karchem Consulting is fully versed on the current guidance (cGMP/cGAMP) across all stages of development and can help you ensure your system meets those requirements and have the qualification data to back that up.
We provide customized, risk-based, testing and qualification/validation services that can give you peace of mind, while not paying a fortune vendor for a generic output. In addition to consultation services, we provide the following services, and more:
Generation of qualification plans and protocols
Writing test scripts specific to your processes and systems
Execution of test scripts
Generation of qualification reports
Work directly with your QA team for review and approval
And if you do decide to leverage the vendor to execute your qualification, we can work with the vendor to ensure their testing scripts and qualification documentation meets your specific needs.
To learn more about what we can offer you, click below to contact us about your needs.