What are the main changes in the FDA’s final CSA guidance (2026)?

The final CSA guidance clarifies the 2022 draft, adding definitions for cloud models (SaaS, PaaS, IaaS) and explicit inclusion of AI/ML systems. It emphasizes risk-based assurance, cybersecurity evidence, 21 CFR Part 11 application, and expanded vendor oversight, using digital records and change-management expectations.

Does the final CSA guidance require validating SaaS and cloud-based tools?

Yes, when cloud or SaaS tools affect the quality system, product, patient safety, or regulated records. The guidance stresses using risk assessment to determine scope, noting that tools purely for administrative use outside the QMS may not require validation.

How does the final guidance address 21 CFR Part 11 compliance?

The FDA clarifies that validation should be risk-based and tied to record integrity. Manufacturers should focus assurance on functions affecting electronic records, audit trails, and signatures. Native digital records are now acceptable evidence, reducing reliance on paper or screenshots.

Does the final CSA guidance encourage using system logs and audit trails as validation evidence?

Yes. The final guidance supports leveraging native digital records like system logs and audit trails as objective assurance evidence. This reduces manual documentation and the need for duplicating evidence that the system already retains electronically.

What does the FDA expect for software vendor assessments?

The guidance recommends assessing vendor cybersecurity, development practices, and certifications. It encourages using remote assessments, SOC reports, SBOMs (Software Bill of Materials), and accreditation reviews, recognizing that manufacturers often have limited direct access.

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Why Are Global Sponsors Looking at Brazil Differently?

Why Are Global Sponsors Looking at Brazil Differently?

Brazil is bringing together an increasingly relevant combination for global clinical research: scientific expertise, population diversity, operational competitiveness, and an evolving regulatory environment.

With Law No. 14,874/2024 and ANVISA Resolution RDC No. 945/2024, the country is moving toward a more predictable, risk-based regulatory model — an important factor for companies evaluating where to conduct clinical trials.

There is also a strategic advantage that is difficult to overlook: the diversity of Brazil’s population can contribute to the generation of more representative clinical evidence, when appropriately reflected in study design and patient recruitment.

But approving and initiating studies more efficiently is only part of the equation.

Is your digital infrastructure ready to keep pace with this evolution?

Accelerating a clinical trial without the same level of maturity across systems, processes, and data may simply shift the risk to another stage of the operation.

A critical system without adequate validation evidence. A weakness in data integrity. Digital controls that cannot withstand regulatory inspection.

The speed gained at the beginning can become regulatory risk later.

This is why digital compliance is no longer just a support function. It has become part of the infrastructure required to conduct clinical operations with confidence.

Digital compliance is now part of the infrastructure supporting reliable and inspection-ready clinical operations.

Building digital environments with confidence

At FIVE Validation, we help life sciences companies build digital environments that are inspection-ready and capable of supporting global operations and regulatory submissions.

Computerized System Validation (CSV)
Data Integrity
Digital Quality
AI Governance

Clinical Research in Brazil

The goal is not simply to be compliant. It is to build the confidence that allows innovation to move forward without turning speed into risk.

Brazil represents a real opportunity for global clinical research.

Is your operation ready to capture it?

FIVE helps transform this opportunity into regulatory confidence and clinical success.

SCHEDULE A MEETING HERE →

Frequently Asked Questions (FAQ)

Why is Brazil becoming more attractive for global clinical trials?

Brazil combines scientific expertise, population diversity, research infrastructure, and operational competitiveness. In addition, recent changes in the regulatory environment aim to bring greater predictability and a more risk-based approach to conducting clinical research in the country.

What does Law No. 14,874/2024 mean for clinical research in Brazil?

Law No. 14,874/2024 establishes a legal framework for research involving human subjects in Brazil. For sponsors and organizations conducting clinical trials, this new regulatory landscape makes it even more important to align processes, responsibilities, systems, and controls with applicable requirements.Validation 4.0 focuses on continuous verification using real-time process data.

Why is digital compliance important for clinical trials?

Clinical trials increasingly depend on computerized systems and digital data. Appropriate validation, data integrity, controls, and governance help ensure that information used in clinical and regulatory decisions is reliable, traceable, and capable of withstanding regulatory inspections.

How does computerized system validation reduce risk in clinical trials?

Validation provides documented evidence that computerized systems are fit for their intended use and operate in a controlled manner. In regulated environments, this helps reduce risks related to quality, data integrity, and compliance.

How does FIVE Validation support companies conducting clinical trials in Brazil?

FIVE Validation supports life sciences companies in areas such as Computerized System Validation, Data Integrity, Digital Quality, and AI Governance, helping them build digital environments that are prepared for regulated operations, inspections, and the requirements of global clinical programs.

Author Section

Article written by

Silvia Martins

Silvia is Brazilian electrical engineer and entrepreneur with over 23 years of experience in the Life Sciences industry, working mainly in the biotechnology, pharmaceutical, medical device, and cosmetics sectors.

She has an international background with specialized training in GAMP5® and FDA 21 CFR Part 11 in England, SAP® validation in Germany, and data integrity and governance in Denmark. Lives in the Netherlands, Silvia serves as the CEO and co-founder of FIVE Validation, a company dedicated to simplifying regulatory compliance. She is the visionary behind GO!FIVE®, the digital validation platform, and is also responsible for the content of the FIVE Academy training platform.

Her work focuses on accelerating and optimizing processes with robustness, traceability, and compliance, supporting companies in integrating the ESG culture, particularly in the Social (S) and Governance (G) pillars. Beyond her corporate role, Silvia is available to connect companies from anywhere in the world with the Pastoral do Menor de Sorocaba, in São Paulo state, Brazil, an institution aligned with the United Nations’ Sustainable Development Goals (SDGs) and recognized for its social impact, benefiting more than 1,400 children and adolescents in vulnerable situations every day.

Author Section

Article reviewed by

Lílian Ribeiro

Lílian Ribeiro is a chemical engineer, biomedical systems technologist, postgraduate in Integrated Management Systems, and Data Science and Business Analytics. She has over a decade of technical and commercial experience in the food, pharmaceutical, and healthcare industries. As an advocate for paperless validation, Lilian is passionate about introducing efficiency and innovation into life sciences companies. Her vast experience is fundamental in validation and qualification projects, encompassing digital validation, ERP, EQMS, automation (PW) and IT infrastructure qualification.