Currently browsing "21 CFR Part 11"
Compliance with the FDA’s 21 CFR Part 11 is essential for life sciences organization especially medical device manufacturers. See articles that help you stay in compliance including e-signatures, audit trails, validated software systems and electronic records.
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Achieving Compliance with 21 CFR Part 11
As the world is moving towards digitalization at a faster pace, the use of the computerized system in the life science industry brought a new perspective in terms of using a software application. Going digital has changed the way data is stored and managed. The transition to paperless recording has had a huge impact on […]
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Training Records and 21 CFR Part 11 Compliance: What Organizations Should Know
21 CFR Part 11 applies to all digital records within your life science organization. That includes your learning and development initiatives. It is important to understand how the FDA’s rules affect training records, including their storage, access, and more. Of course, navigating this area can be confusing, so we created a guide to help ensure […]
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How eLeaP Complies with FDA’s 21 CFR Part 11
Life science companies are required to adhere to FDA‘s 21 CFR Part 11 when it comes to digital record storage and access. These rules were handed down as part of the FDA’s strategy for reducing the risk of data breaches and information exposure. However, many companies struggle to understand how the rules apply to them […]
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Medical device manufacturers turn to eLearning to improve TTM
The medical device industry is incredibly competitive and success or failing becomes highly dependent not just on the quality of product you are producing, or the level of innovation, but on how quickly you can introduce it into the marketplace. One of the most important areas of concern is time to market (TTM). The Timeline […]
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Theranos – A Case Study on Risk and Reputation Management
Until recently, no one could get enough of Theranos and the company’s founder, Elizabeth Holmes – the exceptionally young, self-made billionaire whose fortune has been made on a single sought after medical technology: an easier, faster and less invasive way to carry out blood tests. Indeed, Holmes, still in her early thirties, has been widely […]
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Facing an FDA audit in the medical device manufacturing industry
If you are a medical device manufacturer, you already understand the substantial role regulations and regulatory agencies play in your business. In particular, the FDA’s 21 CFR Part 11 standard. The FDA audit is one of the most anxiety-producing prospects for medical device manufacturers, and for many manufacturers, it is also the most challenging part […]
