FireBird is designed to meet ICH E6 Good Clinical Practice and 21 CFR Part 11 for electronic records, and comes with the documentation your quality team needs to assess it.
ICH E6 Good Clinical Practice
Built around the GCP principles: attributable, legible, contemporaneous, original and accurate data. Every entry carries who, when and what changed; nothing is overwritten.
21 CFR Part 11
Designed for Part 11 electronic records: unique accounts and role-based access, time-stamped audit trails that are computer-generated and cannot be edited, and controlled exports that are themselves audited.
Tamper-evident audit trail
Each audit event is hash-chained to the one before it, so any change, deletion or reordering of the trail can be detected and reported.
CTMS designed for validation
FireBird-CTMS is designed to meet the expectations of computerised system validation, with requirements, test evidence and traceability kept as it is built, ready for your vendor assessment.
EDC configured and validated per study
Forms, edit checks and the visit schedule are built from your protocol and frozen as a versioned release. Each release is validated before go-live, and every record keeps the version it was entered under.
De-identified by design
Participants are known only by their participant number. Names never enter the system, and FireBird for Participants accounts are tied to a number, not a person.