| Framework | What It Requires | What PULSE Delivers |
|---|---|---|
FDA AI/ML PCCP Guidance | Documented real-world performance monitoring. Systematic capture of performance signals. Planned model updates based on real-world data. | Trust trajectory monitoring is the real-world performance signal. Falling trajectory triggers documented change control assessment automatically. |
FDA CSA 2022 — Risk-Based Assurance | Higher risk AI requires more rigorous assurance. Risk level must be documented and drive assurance activity selection. | Trust trajectory determines governance weight dynamically. Falling trust = higher risk = heavier assurance. All trajectory changes documented with full ALCOA+ context. |
ICH Q9 — Quality Risk Management | Systematic monitoring of quality risk signals. Risk signals must trigger documented review processes. | Six trust signals monitored continuously per agent. Threshold breach triggers quality team alert with PULSE audit trace and explicit QMS CAPA direction. |
FDA 21 CFR Part 11 | Electronic records must be attributable, legible, contemporaneous, original, accurate. Audit trail of all record creation and modification. | PS-{timestamp}-{hash} cryptographic trace per event. Electronic signature on all manual entries. Immutable audit log. ALCOA+ compliant. FDA inspection ready. |
EU GMP Annex 11 | Computerised systems in GMP must be validated. Performance monitored continuously. Deviations documented and investigated. | Continuous trust trajectory monitoring provides performance evidence. Governance weight adjustment is the documented deviation response. |