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.
-
Medical Device Companies and 21 CFR Part 11 Compliance
The regulations from the US Food and Drug Administration (FDA) that apply to how various life sciences companies handle electronic files and electronic signatures is known as 21 CFR Part 11. One category of companies that must pay special attention to these regulations are those that manufacture and sell medical devices. But medical device companies […]
-
How Life Science Organizations Can Remain Compliant in the Digital Age
With technology rapidly evolving, we have seen the digitization of many processes that were once done manually. The field of life sciences is no exception. Whether you’re a biopharmaceutical, medical device, research, and testing, or bioscience distribution company, it is important to keep detailed records of all transactions. Signature requirements will be of the utmost […]
-
Biopharmaceutical Research and 21 CFR Part 11 Compliance
Whether a biopharmaceutical company is large or small, research is essential to moving industry knowledge forward and achieving the company’s mission. Does biopharmaceutical research fall under the scope of the United States Food and Drug Administration (FDA) 21 CFR Part 11 compliance? The answer is yes if the research site owns, controls, or uses any […]
-
Life Sciences Companies and 21 CFR Part 11 Compliance
In the digital age of the twenty-first century, it’s only natural for all kinds of companies to handle more and more of their business operations digitally. While this process of digitization marches forward, it comes with risks concerning the security of electronic records. For life sciences companies, the United States Food and Drug Administration (FDA) […]
-
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 business. 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 […]
-
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 […]
-
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 […]
-
Focusing on Training Healthcare Providers Through eLearning
If you read our new article about Ebola, and more specifically how the nurses at Texas Health Presbyterian hospital are telling officials they had no training on the disease when they were left to care for the Liberian man who became ill with the disease, you’ve seen how more training was completely necessary and eLearning […]
