GAMP 5 & AI Validation
GAMP 5 & Computer Systems Validation (CSV)
ISPE GAMP 5 aligned CSV programmes for GxP computerised systems — covering risk-based validation, Annex 11 compliance and data integrity obligations.
Risk-based CSV programme design aligned to ISPE GAMP 5 — covering system categorisation, validation planning, IQ/OQ/PQ execution and validation summary reports.
Get Proposal →Full CSV delivery covering URS, FSA, risk assessment, IQ/OQ/PQ protocols and reports — for manufacturing execution systems, LIMS, QMS and clinical systems.
Get Proposal →Annex 11 compliance assessment and remediation covering computerised system lifecycle, electronic records, audit trails, backup and disaster recovery.
Get Proposal →FDA 21 CFR Part 11 compliance assessment and remediation covering electronic records, electronic signatures, audit trails and system access controls.
Get Proposal →GxP computerised system periodic review and revalidation programmes — maintaining validated status across system updates, changes and infrastructure migrations.
Get Proposal →Hands-on CSV remediation for legacy systems with validation gaps — building compliant validation documentation and closing regulatory observations.
Get Proposal →AI & Machine Learning Validation
Validation frameworks for AI and machine learning systems in GxP environments — aligned to ISPE GAMP 5 AI supplement, EU GMP Annex 22 and emerging regulatory guidance.
AI and machine learning validation programmes aligned to ISPE GAMP 5 AI Supplement — covering model validation, performance monitoring and change control.
Get Proposal →EU GMP Annex 22 readiness assessment and implementation for AI systems used in GxP manufacturing and quality decision-making.
Get Proposal →Risk assessment of AI models used in GxP environments — covering intended use, bias risk, model drift, explainability and human oversight requirements.
Get Proposal →Ongoing AI model performance monitoring programme design — ensuring GxP AI systems maintain validated performance throughout their operational lifecycle.
Get Proposal →Data Integrity Programme
Structured data integrity programmes applying ALCOA+ principles — protecting the reliability, accuracy and trustworthiness of your GxP data across all systems and processes.
End-to-end data integrity programme covering ALCOA+ principles, audit trail controls, access management, data lifecycle governance and regulatory alignment.
Get Proposal →Independent data integrity gap assessment identifying vulnerabilities, audit trail deficiencies and ALCOA+ compliance gaps across computerised and paper-based systems.
Get Proposal →Hands-on data integrity remediation programme addressing FDA Warning Letter observations, EMA concerns and internal audit findings related to data reliability.
Get Proposal →Audit trail review SOP design and implementation — ensuring all critical GxP data systems have compliant, routinely reviewed audit trails.
Get Proposal →Why Organisations Choose AjaCertX for GAMP 5 & AI Validation
Deep GAMP 5 expertise combined with emerging AI validation capability — aligned to ISPE guidance, FDA and EU GMP Annex 11 and 22.
Deep GAMP 5 expertise across pharma, biotech and medical devices — aligned to ISPE guidance, FDA expectations and EU GMP Annex 11 and 22.
One of the few validation specialists combining GAMP 5 CSV expertise with AI governance and machine learning validation capability.
We transfer CSV and data integrity knowledge to your team — building internal validation capability that reduces long-term dependency.
All validation deliverables designed to withstand FDA, EMA, MHRA and TGA inspection — not just internal QMS requirements.
How AjaCertX Works With You
A structured engagement methodology — from initial assessment through to ongoing governance and continual improvement.
System categorisation and risk assessment aligned to ISPE GAMP 5 — determining validation requirements, intended use boundaries and effort level.
Validation master plan and system validation plan development — covering lifecycle approach, roles, responsibilities and acceptance criteria.
Installation, operational and performance qualification protocol development and execution — generating compliant validation evidence.
ALCOA+ data integrity assessment and programme design — covering audit trail controls, access management and data lifecycle governance.
AI and machine learning model validation aligned to GAMP 5 AI Supplement and EU GMP Annex 22 — covering model testing, performance monitoring and change control.
Ongoing periodic review and revalidation programme — maintaining validated status across system updates, changes and infrastructure migrations.
Knowledge For Your Team
Analysis of recent FDA warning letters related to AI systems, data integrity and GxP compliance failures — and what they mean for your organisation.
Download Free →The six most common gaps in AI and machine learning validation programmes — and how to close them before your next regulatory inspection.
Download Free →How Annex 22 and the EU AI Act interact — and what life science organisations must do to address both obligations without duplicating effort.
Read More →Our validation specialists walk through AI validation requirements under GAMP 5 AI Supplement and the EU AI Act.
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