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  1. Blog
  2. 21 CFR Part 11

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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  • Hazard Communication

    Intrapersonal Communication: A Path to Self-Discovery

    eLeaP Editorial Team

    August 9, 2024

    5 min read

    Intrapersonal Communication: A Path to Self-Discovery

    Intrapersonal communication is a cornerstone of personal and professional development. This internal dialogue shapes our self-awareness, decision-making, and emotional well-being. By understanding and mastering intrapersonal communication, individuals can unlock new levels of self-discovery and personal growth. This article provides a comprehensive guide to intrapersonal communication, exploring its definition, types, techniques for enhancement, and the numerous […]

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  • 21 CFR Part 11

    Exploring Innovative Solutions and Trends for Electronic Records and Signatures

    eLeaP Editorial Team

    February 15, 2024

    3 min read

    Exploring Innovative Solutions and Trends for Electronic Records and Signatures

    In the fast-evolving world of life sciences, maintaining compliance with regulations is a perpetual challenge. One such pivotal regulation, 21 CFR Part 11, shapes the electronic records and signatures landscape for pharmaceutical, biotechnology, and medical device industries. In a newly released whitepaper, “Navigating 21 CFR Part 11: Solutions for Current Challenges and Future Trends,” organizations […]

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  • 21 CFR Part 11

    Unraveling the Dynamics of Software as a Medical Device (SaMD)

    eLeaP Editorial Team

    January 16, 2024

    12 min read

    Unraveling the Dynamics of Software as a Medical Device (SaMD)

    Software as a Medical Device (SaMD) refers to software intended for medical purposes that does not have a physical form but performs diagnostic or therapeutic functions. The growing integration of technology in healthcare has led to an increased reliance on SaMD, which plays a crucial role in the diagnosis, treatment, and monitoring of medical conditions. […]

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  • Medical Devices

    The Critical Role of Audit Trails in Ensuring Data Integrity and Compliance in the Pharmaceutical, Biotech, and Medical Device Industry

    eLeaP Editorial Team

    January 15, 2024

    13 min read

    The Critical Role of Audit Trails in Ensuring Data Integrity and Compliance in the Pharmaceutical, Biotech, and Medical Device Industry

    In the fast-paced and highly regulated landscape of the pharmaceutical industry, maintaining the highest standards of data integrity and compliance with stringent regulatory standards is crucial. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established stringent guidelines to ensure the quality, safety, and efficacy of […]

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  • Software Validation

    Understanding FDA Software Validation

    eLeaP Editorial Team

    January 12, 2024

    12 min read

    Understanding FDA Software Validation

    In the dynamic landscape of healthcare technology, the development and deployment of software play a crucial role in patient care, diagnostics, and overall healthcare management. However, with innovation comes the need for stringent regulations to ensure the safety and effectiveness of medical software. The Food and Drug Administration (FDA) plays a pivotal role in overseeing […]

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  • 21 CFR Part 11

    21 CFR Part 11 Compliance in the Pharmaceutical Industry

    eLeaP Editorial Team

    January 11, 2024

    11 min read

    21 CFR Part 11 Compliance in the Pharmaceutical Industry

    The pharmaceutical industry operates in a highly regulated environment to ensure the safety and efficacy of drugs. Central to this regulatory framework is 21 CFR Part 11 compliance, a critical aspect that pharmaceutical companies must prioritize. Code of Federal Regulations (CFR) sets the guidelines and standards that companies in the industry must adhere to, making […]

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  • 21 CFR Part 11

    An In-Depth Analysis of FDA 21 CFR Part 211 Compliance in Drug Manufacturing

    eLeaP Editorial Team

    January 10, 2024

    12 min read

    An In-Depth Analysis of FDA 21 CFR Part 211 Compliance in Drug Manufacturing

    The pharmaceutical industry is a highly regulated sector where the standard of quality is most critical and must be adhered to. One of the key regulatory frameworks governing pharma manufacturing is the FDA 21 CFR Part 211, which outlines Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals. This set of regulations is crucial to maintaining […]

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  • 21 CFR Part 11

    Ensuring Data Integrity: A Comprehensive Guide to GxP Compliance in Regulated Industries

    eLeaP Editorial Team

    January 9, 2024

    16 min read

    Ensuring Data Integrity: A Comprehensive Guide to GxP Compliance in Regulated Industries

    In the rapidly evolving landscape of life sciences and regulated industries, adherence to Good Practices (GxP) standards is critical to ensuring the safety, efficacy, and quality of products and services. Among the important parts of GxP compliance are 21 CFR Part 11 and EU Annex 11, guiding principles for electronic records, electronic signatures, and computerized […]

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  • 21 CFR Part 11

    Understanding the Impact of 21 CFR Part 11 on Your Organization

    eLeaP Editorial Team

    February 14, 2023

    4 min read

    Understanding the Impact of 21 CFR Part 11 on Your Organization

    21 CFR Part 11 is the legal framework that controls how businesses handle electronic documents and signatures. To comply with the FDA’s statutory inspection requirements, the regulation develops a framework for managing records and electronic signatures, making them generally similar to paper archives and handwritten signings completed on paper. Here, we’ll be taking a deeper […]

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  • Quality

    Understanding the Distinction Between Quality Assurance and Quality Control: Why It Matters

    Joginder Mittal

    January 2, 2023

    13 min read

    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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  • 21 CFR Part 11

    Research, Testing, and Medical Laboratories: 21 CFR Part 11 Compliance

    eLeaP Editorial Team

    November 11, 2022

    3 min read

    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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  • 21 CFR Part 11

    A Sales LMS Can Help Your Pharmaceutical Reps Thrive. Here’s How.

    eLeaP Editorial Team

    November 2, 2022

    4 min read

    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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