FDA 21 CFR Part 11
Discovery how SoftExpert can revolutionize management in your company!
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 change history.
- Secure retention and archiving policies that meet regulatory requirements.
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.
Accelerate your system validation
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
