Need help with your audit? Browse our FAQs or contact the developer directly.
Developer Address
ProtoAudit
Malappuram
Kerala, India - 673637
Response Time
Usually responds within 24-48 hours.
No. ProtoAudit is a macOS application that processes all data locally on your machine. Sensitive patient data never leaves your device, ensuring full privacy compliance.
The system currently accepts structured .xlsx (Excel) files containing Patients, Investigators, and SiteInfo worksheets. Please refer to the Documentation for the exact schema.
The audit engine supports simultaneous validation against ICH-GCP (E6R2), FDA 21 CFR Part 11, and CDSCO Indian GCP rules.
The score (0-100%) is generated via a weighted algorithm. Critical violations (e.g., unsigned consent) impact the score heavily, while minor data transcription errors have a lower impact.