FDA 21 CFR Part 11

Ensure full control over electronic records and signatures with data traceability, security, and integrity. Reduce risks, streamline processes, and facilitate audits in regulated environments with SoftExpert Suite — a comprehensive software solution designed to meet FDA 21 CFR Part 11 requirements.

Ensure secure, reliable, and auditable records
Full traceability with audit trails recording all system activities.
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

Manage documents efficiently and in compliance

  • 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 a complete change history.
  • Secure retention and archiving policies that meet regulatory requirements.
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Reduced risks and non-conformities

  • 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.
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Accelerate your system validation

SoftExpert’s Validation Services ensure compliance with FDA 21 CFR Part 11, supporting 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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Why do customers choose SoftExpert

CSN Paraná

Success Case
CSN Paraná optimizes indicator management and reduces time, gaining 42 days per year in efficiency
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União Química

Success Case
União Química manages more than 3,000 documents in SoftExpert Suite and increased its productivity in content management by 30%
See The Full Story
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Learn how SoftExpert solutions can help you achieve standards certification and regulatory compliance

Enterprise Content - ECM
Enterprise Quality - EQM

Enterprise Content - ECM

SoftExpert ECM is a comprehensive enterprise content management software solution that centralizes all organizational content. It allows you to create, capture, manage, store, preserve and share documents and records, reducing paperwork and related deviations. The ECM solution ensures security, integrity, reliability, and compliance with international standards such as ISO 9001 and FDA 21 CFR Part 11.

Explore the solution

Enterprise Quality - EQM

Modernize your quality management system (QMS) with an end-to-end solution, reduce the effort to ensure and maintain compliance, gain agility and transparency, and drive continuous improvement with greater efficiency and control so your organization achieves excellence and increases customer satisfaction.

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Compliance with global privacy and security standards

Advanced data protection

SoftExpert ensures the protection of your company's data and compliance with the requirements of the latest standards.

Integrate with your ERP, CRM, Office365, and much more

Connect SoftExpert Suite to other business tools already used in your organization.

Customize the solution to your needs

Add new modules to your product, customize your experience and get all the solutions you need for your company.

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.

FDA 21 CFR Part 820

FDA regulation that establishes the basic requirements applicable to medical device manufacturers.

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