FDA 21 CFR Part 11

Manage electronic records and signatures with data traceability and security. SoftExpert Suite supports organizations in implementing best practices aligned with FDA 21 CFR Part 11, helping reduce risks and streamline audits.

Ensure secure, reliable, and auditable records

Traceability supported by audit trails that document system actions.

Electronic records that are complete, readable, and accessible throughout their entire lifecycle.

Ongoing compliance through validated processes aligned with regulatory requirements.

Ensure the integrity and authenticity of your data and comply with the requirements

Readable and traceable copies with version control, status identification, and support for multiple formats.
Configurable access permissions by user, team, or role.
Electronic signatures with user identification, date, and time.
Protection against unauthorized changes and change history.
Secure retention and archiving policies that meet regulatory requirements.

Identify and mitigate failures through proactive risk management.
Perform root cause analysis using structured, traceable methodologies.
Implement action plans with assigned responsibilities, deadlines, and clearly defined steps.
Maintain contemporaneous records to demonstrate compliance.

SoftExpert Validation Services support compliance with FDA 21 CFR Part 11, ensuring legally valid electronic records and signatures.

Clear planning, with risk-based scope and acceptance criteria.
Objective evidence and complete documentation for audits.
Validation maintained throughout the system’s lifecycle.
Expert technical support for system updates and maintenance.

Learn more about the Validation Service

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Glossary

FDA (Food and Drug Administration)

The U.S. regulatory agency responsible for the safety and efficacy of drugs and food.

FDA 21 CFR Part 11

FDA regulation on electronic records and electronic signatures.

ECM (Enterprise Content Management)

Strategies and technologies to capture, store, and distribute documents related to processes. Frequently integrated with BPMS solutions.

Secure, compliant, and ready to integrate with your ecosystem

Built to connect with your existing stack while keeping governance, traceability, and control at the center.

Recognized Platform

An award-winning platform recognized by customers

Trusted by users and rated across leading software review platforms for value, usability, and support.

Global Thinking with Local Service

SoftExpert's global presence, with operations on every continent, drives its growth by delivering strong, personalized service tailored to each local market.

FDA 21 CFR Part 11

Ensure secure, reliable, and auditable records

Ensure the integrity and authenticity of your data and comply with the requirements

A decision capable of changing the game

Glossary

FDA (Food and Drug Administration)

FDA 21 CFR Part 11

FDA 21 CFR Part 820

ANVISA (Brazilian Health Regulatory Agency)

EFSA

ECM (Enterprise Content Management)

Secure, compliant, and ready to integrate with your ecosystem

An award-winning platform recognized by customers

Global Thinking with Local Service

Ensure the integrity and authenticity of your data and comply with the requirements