In regulated industries, particularly those in pharmaceuticals, biotechnology, and medical devices, maintaining compliance documentation is essential to ensure adherence to legal requirements. One critical regulatory framework that governs electronic records and signatures in these sectors…
System access logs are an essential component of data management and security in regulated environments, particularly when dealing with electronic records and signatures under 21 CFR Part 11. This regulation outlines the requirements for the…
Change control is a critical process for organizations that operate in regulated industries, particularly those adhering to 21 CFR Part 11. This regulation governs the use of electronic records and electronic signatures, requiring that organizations…
Record retention is a fundamental requirement under 21 CFR Part 11, which governs the use of electronic records and electronic signatures in industries regulated by the FDA. Compliance with this regulation ensures that electronic records…
In the context of 21 CFR Part 11, data authentication plays a vital role in ensuring the integrity, security, and authenticity of electronic records. The regulation establishes strict guidelines for the management of electronic records…
Regulatory audits are a crucial component of compliance in industries governed by the 21 CFR Part 11 regulation. This regulation, which applies to organizations handling electronic records and electronic signatures, sets strict standards for data…