Every output is traceable. Every decision is signed. Every model version is locked.
Sabyl is designed for the people who sign the batch, close the investigation, and face the inspector. Deterministic behavior, complete traceability, and audit-grade evidence are not features. They are the foundation.
EU AI Act & Annex 22 Alignment
Sabyl operates as a high-risk AI system under EU AI Act Annex III and is aligned to the finalized EU GMP Annex 22 framework. Each model carries a declared Intended Use (IUD). Prompts are version-controlled. Outputs are deterministic and replayable. A conformity assessment dossier and AI QMS documentation are included in the pilot package.
Electronic Signatures & Traceability
Every human checkpoint within Sabyl captures an electronic signature fully compliant with 21 CFR Part 11 and EU GMP Annex 11. The underlying audit ledger is append-only, capturing the model version, input hash, output hash, and the signer's identity. When Sabyl flags a deviation or surfaces a hypothesis, the human checkpoint is mandatory before any record is written. The agent cannot close a CAPA, release a batch, or file an ICSR without a signed human decision.
Data Integrity (ALCOA+)
Data integrity is continuously monitored across every LIMS and MES source. Our system adheres to the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available), ensuring that every evidence record is attributable, verifiable, and audit-ready.
Validation Package (GAMP 5)
We do not expect you to start from scratch. Sabyl ships with a comprehensive validation package following GAMP 5 principles, including pre-written / preconfigured IQ/OQ/PQ protocols and test sets, plus traceability matrices to accelerate your pilot and deployment.