Does Ideagen Quality Management adhere to Title 21 CFR Part 11?
Achieve 21 CFR Part 11 compliance by using Ideagen Quality Management software to manage electronic records and signatures with precision, security, and regulatory adherence.
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How Ideagen Quality Management simplifies 21 CFR Part 11 compliance
This guide highlights how Ideagen Quality Management software helps organizations meet the requirements of 21 CFR Part 11, including managing electronic records, electronic signatures, and audit trails. Learn how Ideagen solutions ensure the accuracy, security, and integrity of your records to maintain compliance with FDA regulations.
Why you need this guide
Unlock essential strategies to meet FDA’s 21 CFR Part 11 requirements using Ideagen’s robust software solutions.
Electronic records management
Ensure accuracy, reliability, and security for the creation, modification, and maintenance of electronic records.
Audit trail visibility
Utilize secure, time-stamped audit trails that track all interactions with electronic records for improved oversight and regulatory compliance.
Electronic signatures
Implement secure electronic signatures with unique user identification to verify authenticity and accountability.
Data security
Protect records with advanced access controls, encrypted passwords, and user authentication to meet regulatory standards.