As pharmaceutical and biotech companies increasingly adopt AI to manage clinical data, regulatory documentation, and research workflows, security and compliance have become essential criteria when evaluating technology providers.

Frameworks such as SOC 2 and ISO 27001 help organizations assess how vendors protect sensitive information, manage security risks, and maintain reliable operations. But what do these standards actually mean for Life Sciences?

Key security and compliance frameworks in Life Sciences

Not all certifications, audits, and regulatory requirements serve the same purpose. Understanding their differences is important when selecting AI technology providers.

SOC 2 Type 2: independently assessed security controls

Developed by the American Institute of Certified Public Accountants (AICPA), SOC 2 evaluates controls against criteria covering security, availability, processing integrity, confidentiality, and privacy.

A SOC 2 Type 2 report assesses the design and operating effectiveness of controls over a defined period, rather than at a single point in time.

For pharmaceutical organizations working with external AI vendors, this provides valuable evidence of how security practices operate in real environments.

ISO 27001: systematic information security management

ISO/IEC 27001 is an internationally recognized standard for information security management systems (ISMS).

It establishes requirements for identifying, managing, and reducing information security risks through structured policies, controls, and continuous improvement.

Unlike SOC 2, organizations can obtain accredited ISO 27001 certification, demonstrating that their information security management system meets the standard’s requirements.

HIPAA, GDPR and GxP: regulatory obligations

Beyond independent audits and certifications, Life Sciences companies must consider applicable regulatory requirements.

• HIPAA: Protects certain health information in the United States and establishes security requirements for covered entities and business associates.
• GDPR: Regulates the processing of personal data in the European Union, including special protections for health information.
• GxP: Encompasses regulated good practices, including GCP and GMP, supporting quality, data integrity, and patient safety.
• 21 CFR Part 11: Establishes FDA requirements for certain electronic records and electronic signatures.

These requirements are not interchangeable with SOC 2 or ISO 27001. Each addresses different aspects of security, privacy, or regulated operations.

Why do these standards matter for AI in Life Sciences?

When AI platforms process clinical trial information, patient narratives, or regulatory documents, security is only one part of the equation. Organizations also need confidence in how information is accessed, processed, and controlled.

Independent assessments and regulatory controls help support four priorities:

1. Sensitive data protection: Reducing risks associated with unauthorized access, disclosure, or data loss.
2. Vendor risk management: Providing evidence that supports security assessments and procurement decisions.
3. Operational reliability: Establishing controls for monitoring, incident response, and business continuity.
4. Regulatory readiness: Supporting documented processes, traceability, and accountability in regulated workflows.

However, security certification alone does not establish that an AI system is validated for GxP use. Organizations must still evaluate intended use, system performance, data integrity, and applicable validation requirements.

Building trust in agentic AI for Life Sciences

As agentic AI becomes more integrated into clinical and regulatory workflows, organizations need technology providers that combine innovation with established security practices.

At Narrativa, our SOC 2 Type 2 audit, conducted by Sensiba, covers security, availability, and confidentiality controls within our Pharma division. This independent assessment supports our commitment to delivering secure agentic AI solutions for Life Sciences.

For pharmaceutical organizations, the goal is not simply to select a vendor with a particular certification. It is to ensure that security, compliance, and operational controls are appropriate for the sensitivity and regulatory requirements of their workflows.

Frequently asked questions

Is SOC 2 mandatory for pharmaceutical companies?

No. SOC 2 is not a general legal requirement for pharmaceutical companies. However, SOC 2 reports are frequently used as evidence during vendor security assessments and due diligence.

What is the difference between SOC 2 and ISO 27001?

SOC 2 provides an independent auditor’s report on controls within a defined scope. ISO 27001 establishes requirements for an information security management system and allows organizations to obtain certification. Both can support vendor assurance.

Does SOC 2 compliance mean an AI platform is GxP-compliant?

No. SOC 2 evaluates security-related controls, while GxP requirements address regulated processes, quality, and data integrity. A SOC 2 report does not replace risk-based validation or qualification activities.

Which certifications should pharmaceutical companies look for in AI vendors?

SOC 2 reports and ISO 27001 certification are useful security assurance indicators. Companies should also assess applicable HIPAA, GDPR, GxP, and 21 CFR Part 11 requirements, depending on the data, intended use, and regulatory context.