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 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.
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’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
Bring this solution to your company
Why do customers choose SoftExpert
CSN Paraná
União Química
Learn how SoftExpert solutions can help you achieve standards certification and regulatory compliance
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.
Enterprise Quality - EQM
Modernize your quality management system (QMS) with an all-in-one solution. Reduce the effort to stay compliant, increase process agility, and gain transparency to drive continuous improvement with more control and efficiency.
Supplier Lifecycle - SLM
Manage the full lifecycle with a robust, integrated solution that automates processes, qualifies partners, ensures compliance, reduces risks, and provides full performance visibility to boost efficiency and trust across the supply chain.
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.
Worldwide Office Locations
Supporting and implementing your growth and expasion everywhere! We are present locally, ready to ensure that SoftExpert solutions are working without limits.
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.
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