Compliance

Narrativa is compliant with a wide range of GxP standards across multiple sectors, ensuring that the outputs generated by our AI platform adhere to international and regional regulatory requirements. From Good Manufacturing Practice (GMP) to Good Clinical Practice (GCP), we embed compliance deeply into every layer of our system.

Our commitment to GxP standards means that your organization can confidently adopt generative AI technology without compromising on safety, traceability, or regulatory alignment.

Narrativa’s AI solutions are tailored for use in highly regulated environments, including pharmaceuticals, biotechnology, and healthcare. We’ve developed our platform to align with the expectations of auditors, inspectors, and compliance officers—so you don’t have to choose between innovation and regulatory peace of mind.

With built-in features supporting validation, audit trails, and role-based access, our platform helps ensure that every piece of generated content can be verified, attributed, and trusted.

Delivering value through compliance

We believe that compliance drives value. Narrativa’s adherence to GxP standards enhances the quality, reliability, and safety of every outcome we produce. This translates into faster approvals, reduced risk, and stronger confidence in your AI-assisted operations.

Whether you’re automating medical writing, generating clinical trial documentation, or creating regulatory reports, Narrativa empowers your team to work efficiently—without ever compromising compliance.

We are committed to the responsible and ethical use of artificial intelligence (AI) across all our solutions and operations. As a provider of AI-driven content automation for highly regulated sectors such as life sciences, we recognize the importance of transparency, fairness, and accountability in the deployment of AI technologies.

1. Purpose

This policy establishes the principles and practices governing the development, deployment, and use of AI technologies within our organization to ensure compliance with applicable regulations and to promote trust among stakeholders.

2. Principles

– Transparency: We strive to ensure that AI-generated content is explainable and traceable, particularly in clinical and regulatory applications. Outputs are auditable, and data lineage is maintained throughout the process.

– Data Privacy: We adhere strictly to GDPR, HIPAA, and other relevant data protection laws, ensuring all data processed by our AI systems is handled securely and ethically.

– Human-in-the-Loop: All AI outputs, especially those used in medical writing or regulatory contexts, are subject to expert human review to ensure accuracy, contextual relevance, and regulatory compliance.

– Bias Mitigation: We continuously monitor and evaluate our models for potential biases and take corrective actions to minimize them.

– Security: All AI systems are developed with robust security protocols, including secure model hosting, encrypted data processing, and regular vulnerability assessments.

– Model Selection and Validation: We utilize a mix of commercial and open-source large language models (LLMs) with rigorous internal evaluation protocols to ensure suitability for use in sensitive domains.

3. Governance

A cross-functional AI Governance Committee oversees the implementation of this policy, monitors compliance, and manages updates based on evolving standards, regulations, and technologies.

4. Continuous Improvement

We commit to the ongoing evaluation of our AI systems, integrating user feedback, regulatory updates, and technological advancements to ensure our practices remain aligned with industry best practices and societal expectations.