In industries that are regulated by the FDA, such as pharmaceuticals, biotechnology, and medical devices, maintaining compliance with 21 CFR Part 11 is critical. This regulation governs the use of electronic records and electronic signatures to ensure data integrity, confidentiality, Read more…
In industries where strict regulatory requirements govern the integrity of electronic records and signatures, such as pharmaceuticals, biotechnology, and healthcare, ensuring the security of sensitive data is paramount. 21 CFR Part 11, issued by the FDA, outlines the rules for Read more…
In regulated industries, especially those governed by 21 CFR Part 11, the integrity of electronic records and signatures is critical. The regulation outlines specific requirements for how electronic records must be maintained, modified, and validated, with a focus on security, Read more…
In the digital era, the management of electronic records and signatures is pivotal for compliance in industries regulated by the FDA, such as pharmaceuticals, clinical trials, and healthcare. The 21 CFR Part 11 regulation establishes the criteria under which electronic Read more…
Data backup and recovery are critical components of any system that manages electronic records and electronic signatures, especially when it comes to compliance with 21 CFR Part 11. This regulation outlines the requirements for electronic records and signatures in regulated Read more…
User Acceptance Testing (UAT) plays a crucial role in ensuring that systems used to manage electronic records and signatures comply with 21 CFR Part 11 requirements. This regulation, issued by the FDA, sets forth strict guidelines for the use of Read more…
