niAnalytics™ was built for conducting clinical studies and it therefore complies with all relevant regulatory requirements as:
- 21 CRF Part 11, an FDA guideline on electronic records and electronic signatures
- HIPAA, the Health Insurance Portability and Accountability Act by the US Congress
- GAMP 5, guidance for the validation of automated systems in the pharmaceutical industry
- Clinical Trials Directive 2001/20/EC
niAnalytics™ fulfills all necessary requirements for use in clinical trials. It can easily be validated as a productive system in a clinical setting.
We will gladly assist you in carrying out a vendor audit. Our preferred third party auditors are also readily available to accompany the process if required.