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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The 3 Q’s in Computer System Validation – IQ OQ PQ
Adopting a Computer Systems Validation approach for the various systems they use is easier said than done when it comes to FDA-regulated organizations. Managing the computer system validation process is often comprehensive, with many steps from beginning to completion. Even one failure in the process can lead to devastating consequences for patients and the organization, […]
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FDA Transition to Computer System Assurance: The New CSV
The 2003 FDA guidance paved the road for implementation of efficient computer system validation for the pharmaceutical industry. Following that FDA guideline, the life science industry has become more efficient in validating computer systems and the documentation in order to comply with regulation, inspections, compliance, and audits. The FDA launched the Case for Quality in […]
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What Is a Validated LMS?
You may have heard the term “validated LMS” being thrown around when it comes to various types of platforms. This is an industry-specific term that’s applied to organizations with certain requirements for compliance and other protocols. Does your organization manufacture food, drugs, medical devices, or anything chemistry-related? You might want to pay close attention to […]
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The Key to Fixing Your Qualification or Validation Strategy
Risk/Impact assessment is key in simplifying your qualification / validation strategy and also in defining the extent of the qualification processes you need to use. It also plays a pivotal role in defining the extent of qualification processes. A risk/impact assessment of the proposed changes should be done to assess the impact of modification/up-gradation activity […]
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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 […]
