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compligen

e‑Validationstar Platform

compligen is a first‑to‑market e‑Validation platform that leverages artificial intelligence to streamline the complex process of Computer System Validation (CSV) and Computer Software Assurance (CSA) in regulated industries. Computer System Validation and assurance ensure that software systems operate accurately, reliably and in compliance with regulatory standards. By digitizing and automating validation workflows, compligen eliminates paper‑based and hybrid validation projects and helps organisations comply with FDA 21 CFR Part 11, EU Annex 11, FDA CSA and CSV from regulators such as the FDA, EMA and MHRA .

Built on more than three decades of FDA CSV compliance experience, compligen combines domain expertise with modern AI technology. The platform’s risk‑based approach is aligned with the FDA’s Computer Software Assurance Assurance (CSA) framework. It assesses each system requirement based on patient safety, product quality and data integrity to ensure critical controls are tested thoroughly while unnecessary activities are reduced.

Key Benefits

  • Improves data integrity by following the ALOCA + principles — data is attributable, legible, contemporaneous, original and accurate .
  • Combines validation deliverables to streamline documentation and testing, accelerating CSV/CSA projects.
  • Offers flexible licensing options to suit both small and large organisations, reducing costs while leveraging powerful AI technology.
  • Ensures compliance with domestic and international regulations and guidances, including FDA’s 21 CFR Part 11 which sets the criteria for electronic records and signatures to be trustworthy and equivalent to paper records, Annex 11, ISO Standards, and GAMP 5 principles.

PlatformFeatures

Risk‑based CSA methodology

compligen uses the FDA’s CSA guidance to tailor the level of validation evidence to the risk each requirement poses to patient safety, product quality and data integrity

Automated documentation

AI‑powered tools generate validation plans, test scripts, traceability matrices and reports, eliminating manual document creation.

Continuous validation

The platform monitors system performance and provides real‑time audit trails, ensuring your system remains compliant throughout its life cycle

Secure cloud repository

maintain all validation artefacts in a central, access‑controlled location for easy retrieval during audits or inspections.

Integration and scalability

compligen integrates with existing quality management systems and scales to support projects of varying size and complexity.

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compligen.ai brings together decades of FDA-compliant validation expertise, cutting-edge AI automation, and regulatory know-how—making cGen the most advanced digital validation platform on the market.

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