Nataile Schibell, MPH and Pippa Hodgkins

As health authorities increasingly rely on real-world evidence (RWE) to inform decisions, expectations around data integrity, methodological rigor, and regulatory compliance have intensified. While scientific credibility has always been essential, recent regulatory and policy shifts—such as the FDA’s Real-World Evidence Framework and the broader move toward value-based care—have made comprehensive traceability and defensibility mandatory. Today, life sciences organizations must generate valid findings and deliver fully auditable, submission-ready evidence to meet evolving regulatory and payer standards.

Among the many regulatory requirements that govern RWE generation, 21 CFR Part 11 plays a key role, particularly for systems that manage electronic records and signatures. But it’s just one piece of a broader compliance landscape, including the U.S. Food and Drug Administration (FDA) and international guidance on study design, data quality, validation, and transparency. Noncompliance can derail submissions, delay market access, and diminish credibility with payers and health technology assessment (HTA) agencies.

Aetion® provides the infrastructure to support compliant study delivery. With built-in controls, standardized workflows, and transparent documentation, Aetion helps organizations implement studies that meet regulatory and scientific standards.

Embedding Compliance in Study Design and Execution

Ensuring compliance with regulatory and scientific standards is critical not only at study submission but throughout the execution process itself. Within Aetion Evidence Platform® (AEP), Substantiate embeds these standards into study workflows, supporting best practices such as protocol locking, controlled access to interim results, and full logging of analytic actions.

These configurable controls enable organizations to maintain flexibility while ensuring study conduct remains transparent, auditable, and aligned with FDA, EMA, PMDA, and global HTA expectations.

Meeting the Requirements of 21 CFR Part 11

Substantiate operationalizes 21 CFR Part 11—a key FDA regulation—by enabling data integrity, user accountability, system validation, and traceability. While distinct requirements exist in the EU under EMA’s Annex 11, Substantiate is designed with global regulatory expectations in mind. The table below outlines how Substantiate enables compliance with core 21 CFR Part 11 requirements within the Aetion Evidence Platform® environment.

Table 1: Substantiate and 21 CFR Part 11 Deliver Compliance in Action

Safeguarding Scientific Integrity Through Built-In Controls

Scientific rigor is the foundation of credible evidence. Substantiate is purpose-built to enforce regulatory-grade standards at every stage of study execution. Through standardized workflows, tamper-proof audit trails, and comprehensive logging, Substantiate enables teams to generate transparent, reproducible, and audit-ready evidence that aligns with the most rigorous regulatory and scientific expectations. Validated processes ensure each analysis is not only methodologically sound but fully defensible in submissions to global regulators and HTA bodies.

Table 2: Platform Controls That Safeguard Scientific Integrity and Ensure Regulatory-Ready Evidence

Scaling Oversight and Consistency Across the Enterprise

Centralized oversight and consistency are vital as RWE initiatives grow across therapeutic areas, geographies, and teams. Aetion supports enterprise-scale operations through features that enable efficient study execution and governance at scale.

Supporting Global Regulatory Engagement

Aetion’s compliance framework is built to support engagement with regulatory authorities and HTA bodies worldwide. Whether navigating FDA requirements, EMA guidance, or regional documentation standards, Aetion Evidence Platform® enables organizations to generate fit-for-purpose evidence aligned with local expectations while maintaining scientific consistency. Through standardized study design and jurisdiction-specific documentation, Aetion helps life sciences teams scale RWE strategies confidently across international markets.

Be ready for every submission. Be certain with Aetion.

In today’s healthcare environment, generating credible, compliant, and defensible real-world evidence is essential. While regulatory compliance begins long before a study is implemented, Aetion embeds scientific and operational rigor into study execution—helping teams deliver audit-ready evidence that supports confident decision-making.

Each study on Substantiate is conducted with precision—aligned with 21 CFR Part 11, guided by validated methods, and fully traceable from data ingestion to result. Leading biopharmaceutical companies, regulators, and HTA agencies rely on Aetion to uphold the highest standards for data integrity, methodological rigor, and regulatory readiness.

Advance with confidence. Submit with certainty. Trust your evidence with Aetion. Let’s move forward—together.