Currently browsing "Medical Devices"
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Understanding the Distinction Between Quality Assurance and Quality Control: Why It Matters
Introduction: In this article, we will examine two key aspects of quality management: quality assurance and quality control. These are two broad approaches that businesses use to ensure that their products or services meet the needs and expectations of customers. Quality assurance involves building quality into the business processes and operations to ensure that high-quality […]
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Research, Testing, and Medical Laboratories: 21 CFR Part 11 Compliance
Laboratories in the field of life sciences play an essential role in research, testing, and product development for medical devices and drugs of all kinds. Without them, the medical supply chain would find itself severely constrained and developing, making, and distributing the life-saving drugs and devices consumers need would be in jeopardy. There’s a lot […]
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A Sales LMS Can Help Your Pharmaceutical Reps Thrive. Here’s How.
A large portion of the success of the pharmaceutical industry revolves around successful sales. Without good sales reps, the industry like other would easily falter. But selling pharmaceuticals can be a difficult and demanding job, and without proper training, tips, and guidance, most reps will struggle to be successful. Fortunately, a validated learning management system […]
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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 […]
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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 […]
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Biopharmaceutical Research and 21 CFR Part 11 Compliance
Whether a biopharmaceutical organization is large or small, research is essential to moving industry knowledge forward and achieving the organization’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 […]
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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) […]
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Decoding 21 CFR Part 11 – 10 Steps to Achieving Compliance
What is 21 CFR Part 11? 21 CFR Part 11 establishes FDA regulations on Electronic Records & Electronic Signature (ERES), which includes electronic submissions to the FDA. 21 CFR Part 11 defines the criteria under which ERES is considered Trustworthy, Reliable, and Equivalent to paper records. Title 21 is the portion of the Code of […]
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9 Tips To Comply with 21 CFR Part 11
For highly regulated medical device organizations and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter of concern for companies subjected to FDA inspections. Organizations must follow best practices for maintaining compliance and quality process by following the 21 CFR Part 11 regulation. However, as more […]
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All you need to know about FDA Form 483 and Warning Letter
When you are working for a drug manufacturing unit, clinical trials facilities, or a medical device company, you can expect random and routine inspections by FDA. The FDA regulates food, medicines, vaccines, medical devices, cosmetics, and tobacco products. The riskiest stake a pharmaceutical company can make is to be questionable for its quality practices by […]
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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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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 […]
