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According to the FDA, inadequate standard operating procedures (SOPs) are one of the most frequently cited causes of non-compliance warning letters. And while a poorly written SOP can cause a multitude of additional major compliance problems, a...
Tags: document control, FDA Compliant Document Control Software, fda guidelines, sop management, what are sops
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
For medical device manufacturers, meeting compliance standards is an essential piece of the quality process. One of the most important of these necessary regulations is FDA 21 CFR Part 820, which ensures that medical devices are safe and effective....
Tags: FDA Compliant Document Control Software, medical device regulations, FDA 21 CFR Part 820
Being part of the pharmaceutical industry requires strict adherence to many government regulations and careful organization of thousands of complex documents. The FDA, EPA and other regulatory bodies are constantly adding quality requirements and...
Tags: document control, version control software, FDA Compliant Document Control Software, pharmaceutical, pharmaceutical industry document control
Compliance is a top concern for businesses across industries, including healthcare, medical device, laboratories, and more. To stay compliant, organizations need to make sure multiple aspects of their operations are following regulations set forth...
Tags: FDA Compliant Document Control Software, FDA Electronic Signature, Electronic Signature, Digital signature, 21 CFR compliance