Electronic Records and Electronic Signatures Compliance Solutions
AGM Network provides comprehensive solutions to help life sciences organizations achieve and maintain compliance with FDA's 21 CFR Part 11 regulations for electronic records and electronic signatures.
Implement secure electronic record systems that meet FDA requirements for accuracy, reliability, and consistent intended performance.
Deploy compliant electronic signature solutions with proper authentication, authorization, and non-repudiation controls.
Establish robust user access controls with unique user identification, authentication mechanisms, and authority checks.
Maintain comprehensive, time-stamped audit trails that capture all record creation, modification, and deletion activities.
Conduct thorough computer system validation to ensure systems perform as intended and maintain data integrity.
Implement controls to ensure data integrity throughout the entire lifecycle, from creation to retention and disposal.
Create and maintain Standard Operating Procedures for electronic record and signature management.
Comprehensive training on 21 CFR Part 11 requirements, system use, and compliance responsibilities.
Regular gap assessments and audits to identify and address compliance issues before regulatory inspections.
Systems must be validated to ensure accuracy, reliability, consistent intended performance, and ability to discern invalid or altered records.
Computer-generated, time-stamped audit trail to independently record date and time of operator entries and actions.
Use of operational system checks and authority checks to enforce permitted sequencing of steps and authorized personnel access.
Systems must verify the identity of individuals to ensure that attempted use by unauthorized individuals is detected.
Ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection.
Maintain documentation including written policies, standard operating procedures, and validation documentation.
Deep experience in pharmaceutical, biotechnology, and medical device industries with proven FDA compliance track record.
End-to-end solutions covering technology, processes, and people aspects of 21 CFR Part 11 compliance.
Continuous monitoring, updates, and support to maintain compliance as regulations and systems evolve.
Contact AGM Network to discuss how we can help you achieve and maintain electronic records and signatures compliance.
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