Ready for Your Annex 11 Validation
Download BatchCortex's complete GMP validation documentation package. Pre-written IQ/OQ protocols, supplier quality assessment, and change control SOP — everything your QA team needs to validate BatchCortex in your GMP environment.
Supplier Quality Assessment Pack
Evidence that BatchCortex operates under a GMP-aligned quality system. Covers software development controls, data integrity controls, AI/ML governance (Annex 22), sub-processor disclosure, and available validation documentation. Required for GAMP 5 supplier qualification under Annex 11.
Validation Support Package (IQ/OQ)
Pre-written Installation Qualification and Operational Qualification test protocols covering 26 test cases across anomaly detection, electronic signatures, audit trail integrity, escalation system, and store-and-forward buffer. Execute and sign — system validated. Includes full traceability matrix mapping requirements to regulatory basis and test evidence.
Change Control SOP
Standard operating procedure defining how BatchCortex manages software changes and notifies validated customers. Covers Minor, Major, Critical, and AI Model change classifications with notification timelines and re-qualification guidance. Aligned with Annex 11 §10 change management requirements.
What is a validated state?
Under EU GMP Annex 11, any computerised system with direct impact on product quality must be validated before use in GMP production. Validation means executing documented test protocols and proving the system works as intended. BatchCortex provides these pre-written protocols so your QA team can validate in days, not months.
Need a customised validation package?
For complex deployments or specific regulatory requirements, we provide tailored validation support. Contact us to discuss your site's specific needs.
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