Know your inspection readiness score before the inspector does.

Sabyl is an agentic operating layer for pharmaceutical quality, pharmacovigilance and regulatory affairs. Eight specialist agents, one regulated system, with deterministic detection, human checkpoints and an audit ledger that survives inspection.

Request a pilot
Meet the agents
QP batch review time
-40%

target Y1 (measured in controlled pilot)

ICSR processing
45 min

from 6.5h (OQ target)

MedDRA Top-1 coding
>=85%

OQ set target

Inspection dossier
<2h

from 4-6 wk (measured in controlled pilot)

Sentinel · Live deviation board

Amoxicilline 500mg · PHR-24081-A

QP review

SPC · dissolution

Last 40 batches

Nelson rule 1
B-001B-020B-040
Root cause0.91
1Mill-03 overdue maintenance
2Similar f2 dip in 2025-1103-C
3Compression speed drift

Audit trail

IUD-SEN-001
hash a74c...e119
e-signature checkpoint

Inspection readiness

82/100

+9 this week

Batch pages skipped

211

3 require QP

Time to dossier

01:48

ANSM format

Designed aroundEU GMP Annex 22EU AI ActICH Q8-Q12GAMP 5ALCOA+ISO/IEC 42001PIC/S
Mid-market pharma · MENA & France

The work is regulated. The current tools are not built for the people signing the batch.

Sabyl is not a generic AI layer. It is built for QPs, QA leads, PV officers and regulatory teams who need source evidence, controlled model versions and inspection-ready records.

Today

Manual, reactive, disconnected.

  • QPs review 50-300 page batch records line-by-line while judgment waits behind mechanical checking.
  • Each ICSR takes 6.5 hours to process and MedDRA coding is still handled manually.
  • CAPA selection relies on memory instead of historical effectiveness and similar-case retrieval.
  • Inspection prep becomes a 4-6 week scramble because readiness is not visible daily.

With Sabyl

Continuous, statistical, multilingual.

  • GUARDIAN shows only the three pages that matter, annotated and scored.
  • SENTINEL retrieves similar deviations and ranks root-cause hypotheses.
  • ALCOA+ GUARDIAN monitors every LIMS and MES audit trail continuously.
  • ORACLE turns site operating history into a queryable knowledge graph.
Eight agents · one ledger

A pharma intelligence operating system, not a chatbot wrapper.

Each agent has a narrow regulated job, a declared intended use, controlled prompts and a shared evidence record.

01 · SENTINEL · DEV

Sentinel

Deviation & CAPA intelligence

Real-time anomaly detection across MES, LIMS and equipment. SIE statistical engine, Nelson-rule control charts, historical deviation retrieval, ranked root-cause hypotheses.

Mode A · Mode B
02 · GUARDIAN · QP

Guardian

Batch record intelligence

Annotated batch record review for Qualified Persons. Surfaces the three pages that matter, flags missing signatures, cross-checks against historical SPC trends. Electronic-signature release.

QP release authority
03 · PHARMAWATCH · PV

Pharmawatch

Pharmacovigilance

ICSR intake, MedDRA auto-coding, narrative drafting, E2B(R3) submission. Signal detection via PRR, ROR and BCPNN across FAERS, VigiBase, EudraVigilance, VigiMed, and Morocco's CAPM.

>=85% MedDRA Top-1
04 · NAVIGATOR · RA

Navigator

Regulatory affairs

Portfolio gap analysis across ANSM, ANMPS, AMMPS, ANPP, SFDA, EMA and FDA (supported in upcoming release). Drafts Dual-Mode (eCTD 4.0 / 3.2.2) variation dossiers per-authority. Tracks every circular and monograph change against your products.

Multi-jurisdiction CTD
05 · SENTINEL-GMP · GMP

Sentinel-GMP

Inspection readiness

Live Inspection Readiness Score across 8 dimensions. Inspection dossier generation in under two hours - for ANSM, FDA, EMA or SFDA, pre-formatted and evidence-linked.

IRS · 8 dimensions
06 · ALCOA+ · DI

ALCOA+ Guardian

Data integrity

Continuous monitoring of every LIMS and MES audit trail. Timestamp anomalies, shared-credential detection, Benford's Law on manual entries, cross-system consistency checks.

ALCOA+ · 10 principles
07 · ORACLE · XFN

Oracle

Cross-agent intelligence

Your site's operating history as a knowledge graph. Natural-language queries in Arabic, French and English. Auto-generates the APQR. Surfaces patterns no single agent can see.

PQI · Graph queries
08 · ACADEMY · LRN

Academy

Training intelligence

Simulations generated from your own deviation history. Competency tracking against HEXACO profiles. SCORM export. Closes the training-gap to deviation loop inspectors love to find.

SCORM · LMS-ready
Workflow

One closed loop from source system to inspector evidence.

Sabyl keeps the AI useful without hiding responsibility: it detects, explains and assembles evidence, while human decisions stay explicit and signed.

01 · regulated workflow

Ingest

PAS-X connected
LabWare connected
SAP mapped
812k audit events indexed
deterministic replayenabled
human checkpointrequired
ANNEX 22

AI in GMP

Aligned to EU GMP Annex 22 draft (consultation closed Oct 2025; final expected 2026). Statistical engines (Nelson rules, SIE) carry GMP-critical weight; LLM agents operate in advisory roles. IUD per model, confidence signals, change control, deterministic replay.

EU AI ACT

High-risk aligned

Conformity assessment, technical documentation, AI QMS. Effective 2 December 2027 (Digital Omnibus, May 7, 2026). Conformity assessment and technical documentation pre-prepared.

ALCOA+

Ten principles

Attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available.

GAMP 5 · 21 CFR Part 11

Validation & e-sig

IQ/OQ/PQ test batteries shipped with the platform based on GAMP 5 (2nd Ed., 2022). Electronic signatures on every human checkpoint, compliant with 21 CFR Part 11 and EU Annex 11.

Read our full validation methodology
Who this is for

Four roles, four bottlenecks. Each one has an agent behind it.

Sabyl is not a dashboard for management. It is a working surface for the people who sign the batch, close the investigation, file the ICSR and face the inspector.

QP

Qualified Person

Batch release authority

5-8 batch records per week, 50-300 pages each. The judgment is irreplaceable. The mechanical checking is not.

"Show me only the three pages that matter."

QA

QA Investigation Lead

Deviation & CAPA ownership

Every investigation starts from scratch: rebuilding timelines, finding precedents, assembling evidence. The work before the work.

"Rank the five most similar cases before I open the file."

PV

Pharmacovigilance Officer

Safety case management

80-150 ICSRs per month across multiple jurisdictions. MedDRA coding, narrative drafting, E2B submission. The deadlines never pause.

"Never miss a 7-day or 15-day deadline again."

DIR

QA Director

Site quality governance

Needs one number to trust before the inspector arrives. Today, the institutional knowledge lives in one person's head. That is a single point of failure.

"Give me my Inspection Readiness Score right now."
Deployment

How a pilot works

We start with a contained scope: one product family, one site, one defined GxP perimeter. You are not buying a multi-year software project.

01

12-week deployment

From kick-off to a live, validated production environment.

02

Validation package

We provide the IQ/OQ/PQ scripts, the Intended Use Declaration, and the traceability matrix.

03

Defined success criteria

We agree on the target KPIs upfront before writing a line of code.

If we do not hit the targets we agreed on, the pilot is free.

Design philosophy
AI that an inspector can audit is the only AI worth deploying.

Every output traces back to a model version, an input hash and a human signature. Prompts are version-controlled. Decisions are deterministic and replayable. The audit ledger is append-only and verified nightly.

Sabyl is not AI added on top of a quality system. It is a quality system where AI is a first-class, regulated component, designed for Annex 22, the EU AI Act and ALCOA+ from the first line of code.

Built for sovereign boundaries. Sabyl deploys to local infrastructure or compliant private clouds (e.g., Amazon Bedrock eu-west-3 in Paris), ensuring patient data and batch records never cross borders without explicit authorization.

Become a pilot client
Platform

One operating system, organized into three product layers.

CORE

SENTINEL + GUARDIAN

Deviation detection (Mode A) and QP batch record review. The operational core for release-critical quality workflows.

Daily site operations
INTEGRITY

SENTINEL Mode B · ALCOA+ · SENTINEL-GMP · Academy

Cross-batch trending, continuous data integrity, live inspection readiness, and training simulations grounded in your own deviation history.

Inspection and quality system depth
INTELLIGENCE

PHARMAWATCH · NAVIGATOR · ORACLE

PV signal detection against FAERS and VigiBase, multi-jurisdiction regulatory affairs, and a cross-agent knowledge graph.

Regulatory and safety intelligence
Sabyl Academy

Master Pharmaceutical Intelligence

Discover our courses designed for quality experts.

Conformité EU AI Act : Évaluation d'Impact des Droits Fondamentaux appliqué aux Vaccins ARNm
Gouvernance & Séc. IA
Intermédiaire•14h

Conformité EU AI Act : Évaluation d'Impact des Droits Fondamentaux appliqué aux Vaccins ARNm

Processus d'audit obligatoire pour les systèmes d'IA de santé à haut risque : Annexe III pour les systèmes standalone (FRIA obligatoire), Annexe I + Article 6(1) pour les IA intégrées dans des dispositifs médicaux et IVD. Préparez vos organisations aux nouvelles échéances issues de l'accord Digital Omnibus (7 mai 2026) : 2 décembre 2027 pour les systèmes IA standalone à haut risque (Annexe III), 2 août 2028 pour les systèmes IA intégrés dans des dispositifs réglementés (Annexe I, Article 6.1). Le cours aborde les biais algorithmiques et les risques éthiques inhérents à l'utilisation de données de formulation lipidique et d'essais immunologiques accélérés, avec des études de cas focalisées sur les enjeux des vaccins ARNm.

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Edge AI pour le Real-Time Release Testing (RTRT) appliqué aux Vaccins ARNm
IA Fabrication GMP
Avancé•14h

Edge AI pour le Real-Time Release Testing (RTRT) appliqué aux Vaccins ARNm

Déploiement de modèles d'inférence directement sur les capteurs de lignes de production (Edge Computing) pour l'optimisation PAT et la libération de lots en continu. Cette maîtrise du RTRT est critique pour répondre aux standards de qualité des vaccins ARNm. Vous apprendrez à traiter en temps réel (inférence sous la milliseconde) des données de formulation lipidique et d'essais immunologiques accélérés sans compromettre l'intégrité des données.

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IA Agentique et Opérations de Pharmacovigilance à l'Échelle appliqué aux Vaccins ARNm
IA Management
Intermédiaire•14h

IA Agentique et Opérations de Pharmacovigilance à l'Échelle appliqué aux Vaccins ARNm

Orchestration multi-agents pour le triage, la traduction, la détection de signaux et la rédaction de narratives de cas (ICSR). En appliquant un workflow "Human-in-the-Loop" supervisé, ce cours démontre comment automatiser la vigilance post-commercialisation spécifique des vaccins ARNm. L'architecture est conçue pour gérer le volume et la complexité des données de formulation lipidique et d'essais immunologiques accélérés.

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Federated Learning pour la Qualité et la Résilience Supply Chain appliqué aux Vaccins ARNm
IA Supply Chain
Avancé•14h

Federated Learning pour la Qualité et la Résilience Supply Chain appliqué aux Vaccins ARNm

Déploiement du federated learning inter-organisationnel pour des cas d'usage supply chain et qualité documentés en 2026 : modèles de prédiction de qualité partagés entre sites de fabrication sans transfert de données propriétaires, surveillance partagée des signaux qualité fournisseurs, et conformité Critical Medicines Act 2026. Ce cadre garantit la confidentialité IP tout en construisant une intelligence collective sur l'approvisionnement, un enjeu majeur face aux exigences des vaccins ARNm. Le modèle s'entraîne de manière distribuée sur des données de formulation lipidique et d'essais immunologiques accélérés pour une résilience maximale.

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Jumeaux Numériques Cliniques avancés (PROCOVA (EMA qualification opinion: September 2022)) appliqué aux Vaccins ARNm
IA Clinique
Avancé•14h

Jumeaux Numériques Cliniques avancés (PROCOVA (EMA qualification opinion: September 2022)) appliqué aux Vaccins ARNm

Création de bras de contrôle virtuels (VCA) par inférence causale. Exploitant les qualifications EMA 2022 pour la réduction des tailles de cohortes dans les essais de phase 2/3, cette approche est révolutionnaire pour des vaccins ARNm. Le cours montre comment synthétiser des trajectoires patients fiables à partir de données de formulation lipidique et d'essais immunologiques accélérés tout en maintenant le contrôle de l'erreur de type 1.

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Quantum Machine Learning (QML) : Perspectives et Préparation Stratégique appliqué aux Vaccins ARNm
IA R&D
Avancé•14h

Quantum Machine Learning (QML) : Perspectives et Préparation Stratégique appliqué aux Vaccins ARNm

Veille technologique critique sur le Quantum Machine Learning (QML) hybride classique-quantique (VQE, QAOA) et ses perspectives à 5-10 ans pour la pharma. Les ordinateurs quantiques fault-tolerant nécessaires aux applications biomoléculaires réalistes ne sont pas disponibles en 2026 (Nature npj Drug Discovery, janvier 2026) — ce cours prépare les équipes R&D à anticiper les ruptures QML, évaluer les investissements, et comprendre les premières applications hybrides NISQ (NISQ-era) pertinentes pour l'optimisation de la stabilité de l'ARNm, la conception des nanoparticules lipidiques (LNP) et la prédiction de la réponse antigénique. Le programme met l'accent sur la modélisation à l'échelle quantique en exploitant des données de formulation lipidique et d'essais immunologiques accélérés.

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View all courses (99+)
FAQ

Questions from QPs, CIOs and QA directors.

Sabyl is built for mid-market pharma teams in MENA and France that need an Arabic and French-native workflow, inspection-grade traceability, and a deployment path that fits a pilot-scale budget. The product is designed around deterministic statistical detection and continuous monitoring, not just narrative summarization.

Pilot deployment

Start with one site. Prove it in twelve weeks.

12-week deploymentValidation package includedDefined scope and success criteria

If we do not hit the targets we agreed on, the pilot is free.