FDA 21 CFR Part 11

Leverage the advanced capabilities of SoftExpert Suite to ensure the security, integrity, and reliability of electronic records in compliance with FDA 21 CFR 11 requirements.

Solve your challenges
Effectively maintain and manage electronic records with accuracy, completeness, and readability over time.
The process requires thorough documentation, rigorous testing, and compliance throughout the system's entire lifecycle.
Ensure that users seek compliance and adhere to established procedures and policies.

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

Compliant electronic signatures

Secure processes with the implementation of electronic signatures, ensuring the authenticity and traceability of electronic records while reducing paper usage and streamlining approval processes.
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Reduced risks and non-conformities

Count on a robust solution for FDA 21 CFR Part 11 compliance and significantly reduce the risk of non-conformities and regulatory violations.
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Access control and record auditing

Maintain granular control over access based on user roles, implement a comprehensive audit trail, and enable continuous monitoring to ensure that only authorized users can access electronic records and that all activities are registered and traceable.
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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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Adami

Success Case
Adami S.A. increases performance with SoftExpert's strategic indicator management solution
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Helibras

Success Case
Helibras, an Airbus Group company, improves document management with a SoftExpert solution
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Simoldes Plastic Division

Success Case
Simoldes Plastic Division increases productivity in Portugal with SoftExpert
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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%
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A complete solution that integrates all your company's processes, promoting efficiency and ensuring compliance with regulatory requirements.

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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.

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Enterprise Quality - EQM

Modernize your quality management system with quality management software, reduce the work required to maintain compliance, improve agility and transparency, and promote continuous improvement across your organization while increasing customer satisfaction.

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