Built for compliance.
Not retrofitted for it.
BatchCortex was designed from line one to meet the most demanding pharmaceutical regulatory requirements. Every architecture decision reflects GMP compliance — not as an afterthought, but as the foundation.
Regulatory Coverage
Every regulation. Addressed by design.
Pharmaceutical manufacturers operate under overlapping regulatory frameworks. BatchCortex maps to each requirement explicitly — so your validation team has the answers before they ask the questions.
Electronic records and electronic signatures in EU-regulated pharmaceutical manufacturing.
View DetailsThe first EU regulatory framework specifically addressing AI and machine learning in GMP manufacturing.
View DetailsFDA requirements for electronic records, electronic signatures, and audit trails in regulated environments.
View DetailsAttributable, Legible, Contemporaneous, Original, Accurate — the gold standard for GMP data integrity.
View DetailsGood Automated Manufacturing Practice — the industry framework for validating computerized systems in pharma.
View DetailsHigh-risk AI classification requirements for systems used in pharmaceutical manufacturing processes.
View DetailsEU GMP Annex 11
Annex 11 to the EU GMP Guidelines establishes requirements for computerized systems used in GMP-regulated manufacturing. It covers system validation, data integrity, audit trails, and electronic signatures. BatchCortex is architected to meet every relevant clause.
| Annex 11 Clause | Requirement | BatchCortex Implementation |
|---|---|---|
| Clause 7.1 | Data must be attributed to the person creating it | Every event logged with user ID, full name, role, and timestamp. Immutable SHA256 hash on creation. |
| Clause 8.1 | Audit trail must record creation, modification, deletion | Append-only events_log table. Row-level security prevents modification. Deletions are architecturally impossible. |
| Clause 9 | Electronic signatures must be equivalent to handwritten | Password re-authentication required at moment of signing. Signer name, role, timestamp, and IP address captured and hashed. |
| Clause 10 | Printouts must indicate if data has been changed | Audit trail export includes full event history with SHA256 verification. Any tampering is detectable. |
| Clause 11 | Systems must prevent unauthorized access | Multi-role authentication. Role-based access control. Rate limiting on all API endpoints. Session management via Supabase Auth. |
EU GMP Annex 22
Annex 22 is the most significant regulatory development for pharmaceutical AI in a generation. It establishes the framework under which AI systems can be used in GMP-regulated manufacturing — and BatchCortex was designed with every clause in mind.
The Four Pillars of Annex 22 Compliance
Human-On-The-Loop
Annex 22 prohibits fully autonomous AI decisions for critical GMP processes. Every BatchCortex recommendation requires explicit human approval before execution. The AI analyzes and proposes — the qualified person decides.
Model Version Control
Every batch record permanently identifies the exact AI model version active during monitoring. Model updates follow change control procedures. You always know which model made which recommendation.
Explainability
Black-box AI outputs are not acceptable under Annex 22. Every BatchCortex recommendation includes a human-readable rationale, confidence score, and the specific sensor data that triggered it.
Validated Infrastructure
The hosting environment, data pipeline, and application are designed for GAMP 5 validation. Full validation package available for pilot partners.
THE ANNEX 22 DISTINCTION
Annex 22 draws a clear line between continuous learning AI (prohibited in live GMP operations) and inference-based AI (permitted with validation). BatchCortex uses fixed, versioned models for production inference. Models are trained offline and deployed as immutable releases — never updated silently during live batch operations.
21 CFR Part 11
21 CFR Part 11 establishes FDA requirements for electronic records and electronic signatures in regulated industries. Though a US regulation, it is widely adopted as the global gold standard for GMP electronic systems and is required by many multinational pharmaceutical manufacturers.
Closed System Controls
BatchCortex operates as a closed system with controlled access. All users are authenticated, all actions are attributed, and the system prevents unauthorized modifications.
Audit Trail
Automatically generated, computer-generated audit trail records the date and time of operator entries and actions. Retained for the life of the record.
Electronic Signatures
Signatures are unique to one individual, cannot be reused or reassigned, and include the printed name of the signer, date/time, and the meaning of the signature.
ALCOA+ Data Integrity
ALCOA+ is the pharmaceutical industry's framework for data integrity — the foundation of GMP compliance. Every data point in BatchCortex is designed to meet all nine ALCOA+ principles.
Attributable
Every sensor reading, event, and signature is linked to a specific user or system actor with full identity metadata.
Legible
All records stored in structured, readable formats. Human-readable audit trail export. No proprietary binary formats.
Contemporaneous
Events logged at the moment they occur with server-side timestamps. Client timestamps are never trusted for audit purposes.
Original
First capture is the record of truth. No transcription, no manual entry of automated data.
Accurate
Sensor values recorded exactly as received from equipment. AI analysis is clearly separated from raw data. No rounding or approximation in storage.
Complete
Full batch lifecycle captured from start to release. No gaps in the audit trail are possible by system design.
Consistent
Timestamps use UTC ISO 8601 throughout. No timezone ambiguity in any record.
Enduring
Records designed for long-term retention. Supabase row-level security prevents deletion. SHA256 hashes enable integrity verification at any future point.
Available
Records accessible to authorized personnel on demand. Export functionality for regulatory inspection. No data locked in proprietary systems.
GAMP 5
GAMP 5 (Good Automated Manufacturing Practice) is the pharmaceutical industry's framework for validating computerized systems. It defines software categories based on complexity and risk, each requiring different levels of validation evidence.
BatchCortex is a GAMP 5 Category 5 System
Configured and custom software with AI/ML components. Requires the highest level of validation documentation.
What the Validation Package Includes
GMP Validation Documents Available
BatchCortex provides a complete validation documentation package including IQ/OQ test protocols and supplier quality assessment. Download from our Validation Documentation page.
View Validation Documents →EU AI Act
The EU AI Act classifies AI systems used in pharmaceutical manufacturing as high-risk. This classification triggers specific requirements for transparency, human oversight, robustness, and documentation. BatchCortex is designed to meet all high-risk AI system requirements.
High-Risk Requirements
Our Position
We welcome the EU AI Act's high-risk classification for pharmaceutical AI. Rigorous requirements create a meaningful barrier to entry — protecting manufacturers from unvalidated AI tools and ensuring that only serious, compliant platforms reach the market.
BatchCortex's human-on-the-loop architecture was designed before the EU AI Act was finalized, because it was always the right approach for GMP manufacturing — not because regulation required it.
Compliance Architecture
How compliance flows through every layer
Data Layer
AI Layer
Compliance Layer
Every batch generates a complete, verifiable compliance record — from first sensor reading to QP release signature.
Ready to discuss your validation requirements?
We work directly with QA Directors, Qualified Persons, and validation engineers to ensure BatchCortex fits your compliance framework. Request our validation documentation or schedule a technical review.
Validation package available to pilot partners · GAMP 5 Category 5 · EU Annex 22 Ready