Inspection Readiness with 21 CFR Part 11 for Electronic Records
In industries that are regulated by the FDA, such as pharmaceuticals, biotechnology, and medical devices, maintaining compliance with 21 CFR […]
December 7, 2024
Security with Multi-Factor Authentication in 21 CFR Part 11
In industries where strict regulatory requirements govern the integrity of electronic records and signatures, such as pharmaceuticals, biotechnology, and healthcare,
Compliance with Data Modification Logs under 21 CFR Part 11
In regulated industries, especially those governed by 21 CFR Part 11, the integrity of electronic records and signatures is critical.
Navigating Regulatory Signatory Requirements under 21 CFR Part 11
In the digital era, the management of electronic records and signatures is pivotal for compliance in industries regulated by the
Compliance with Data Backup and Recovery in 21 CFR Part 11
Data backup and recovery are critical components of any system that manages electronic records and electronic signatures, especially when it
User Acceptance Testing (UAT) in System Validation for 21 CFR Part 11
User Acceptance Testing (UAT) plays a crucial role in ensuring that systems used to manage electronic records and signatures comply