Consulting
Systems Validation
We have extensive experience in validating IT Systems which are designed in compliance to support key regulatory guidelines and requirements, such as HIPAA (Health Insurance Portability and Accountability Act), 21 CFR Part 11 for electronic records used in clinical trials, and Good Clinical Practice (GCP). These software may fall under any of the categories like EDC, Biostatistics, Document Management Systems, eCTD or SPL.
Our team can help you in your IT projects from the starting of hardware and software architecture and can enable you to reduce your cost of compliance by doing the right things in the right order.
