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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Decoding 21 CFR Part 11 – 10 Steps to Achieving Compliance
What is 21 CFR Part 11?21 CFR Part 11 establishes US 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 Code of Federal […]
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9 Tips To Comply with 21 CFR Part 11
For highly regulated medical device companies and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter of concern for the companies who are subjected to FDA inspections. Organizations are required to follow best practices for maintaining the compliance and quality process by following the 21 CFR […]
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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
When it comes to the FDA regulated organizations, adopting a Computer Systems Validation approach for the various systems they use is easier said than done. Managing the computer system validation process is often a comprehensive process with many steps from beginning to completion. Even one failure in the process can lead to devastating consequences for […]
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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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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 […]
