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.
-
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 […]
-
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 […]
-
The GAMP Approach to 21 CFR Part 11 Compliance
Organizations in the Life Sciences industry that wish to sell products or services in the United States must comply with 21 CFR Part 11, Electronic Records and Electronic Signatures. This includes research, production, and distribution systems for pharmaceuticals, medical devices, biological products (e.g., vaccines), blood, and tissue (e.g. organ transplants) It is crucial that the […]
-
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 […]
-
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) […]
-
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 […]
-
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 subject to FDA inspections. Organizations must follow best practices in maintaining compliance and the quality process by following the 21 CFR Part 11 regulation. However, as […]
-
All You Need to Know about FDA Form 483 and Warning Letter
When you are working for a drug manufacturing unit, clinical trial facilities, or a medical device company, you can expect random and routine inspections by the FDA. The FDA regulates food, medicines, vaccines, medical devices, cosmetics, and tobacco products. The riskiest stake a pharmaceutical, biotech, medical devices, food, or cosmetics company can take is to […]
-
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, […]
-
FDA Transition to Computer System Assurance: The New CSV
The 2003 FDA guidance paved the road for the 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 documentation in order to comply with regulations, inspections, compliance, and audits. The FDA launched the Case for Quality in […]
-
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 […]
-
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 […]
