Currently browsing "Life Sciences"
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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 companies 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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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/upgrade activity on various […]
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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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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 […]
