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For life science companies, compliance with regulatory standards is paramount to ensure the safety, efficacy, and quality of products and processes. One such critical regulation is FDA CFR Part 11, which governs the use of electronic records and...
Tags: FDA compliance software, Quality Management System, 21 CFR compliance, Compliance, fda cfr part 11
As more companies move their processes into the digital space, new risks concerning the security of electronic records surface. In March of 1997, the United States Federal Food and Drug Administration (FDA) created CFR Part 11 to combat those...
Tags: FDA Compliant Document Control Software, Compliance, fda guidelines, fda cfr part 11