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Getting GxP Ready With Acodis

Compliance with GxP regulations is non-negotiable. Acodis is designed from the start to operate in regulated environments, ensuring reliability, transparency, audit readiness and compliance with GxP, GAMP 5, 21 CFR Part 11 and the European Annex 11.

Acodis' design principles and proprietary algorithms enables large organisation to deploy AI-powered Intelligent Document Processing (IDP) and document process automation capabilities at scale, whilst staying fully aligned with GxP expectations and maintaining the highest security and privacy standards.

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How Acodis Fulfills GxP Compliance

Acodis is designed from the ground up to operate in regulated environments. Our key design principles ensure reliability, transparency, and audit readiness.

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Expert-in-Control

Ensures predictable outputs for high-risk processes while leveraging AI for flexibility, always keeping an expert-in-control.

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Explainability and Transparency

Providing model accuracy, confidence scores, change of version and output with full traceability for auditability.

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Scalability and Composability

Architecture allows to bring-your-own AI within a validated framework, future-proofing compliance.

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Security and Data Privacy​

Adhering to robust security measures including ISO 27001 and ISO 9001 controls.

GxP Compliance and AI

AI systems introduce both opportunities and challenges for regulated industries. Acodis support capturing the benefits of AI while remaining compliant with regulatory standards like 21 CFR Part 11 and EU Annex 11.

We split the validation process into five high steps, whereby each step includes clear objectives and delineates the responsibilities between Acodis and the Client:

  • Step 1 – Define Scope, Intended Use & Risks 
  • Step 2 – Risk Assessment & Validation Planning
  • Step 3 – System Qualification (IQ/OQ)
  • Step 4 – Process Qualification & Training (PQ + SOPs) 
  • Step 5 – Maintain Validated State & Retirement 
Get in touch for further details

Frequently asked questions

Why is GxP compliance critical for AI-powered Document Automation?

Software can be designed or configured to support GxP compliance, but compliance ultimately depends on how the software is used within a validated process. GxP ensures that processes are validated, reliable, and auditable.

Not all software in an organization needs to be GxP-compliant—only those used in regulated workflows that impact product quality, patient safety, or data reporting.

How does Acodis support system validation?

Acodis provides validation-ready documentation (IQ/OQ protocols, model versions, audit logs) and supports clients in PQ execution, making compliance faster and easier..

Can we use our own AI or LLM models with Acodis?

Acodis’ composable architecture allows integration of client-chosen models while maintaining GxP compliance through traceability and validation controls.

How does Acodis handle AI outputs that are uncertain or low-confidence?

Such outputs are flagged for human review. This expert-in-control principle ensures compliance and quality are never compromised.

What types of documents are in scope for AI-powered IDP under GxP?

Examples include manufacturing batch records, regulatory submissions (IND, NDA, MAA, CTD), SOPs/CSPs, quality agreements, and clinical trial documents.

How long does it take to get GxP compliant?

Timelines vary by scope and risk classification. High-risk use cases (e.g., batch record review, regulatory QC) typically take 8–12 weeks to validate end-to-end. Lower-risk use cases (e.g., SOP indexing) can often be validated in 4–6 weeks. Acodis validation guidelines and templates help customers in the process.