• Effective Records: Get Them Right by Getting Proactive with Vendors and Suppliers

    14 April, 2017 Janis V. Olson, Senior Validation Consultant, EduQuest, Inc.

    Poor records – and poor management of good records – can trigger needless costs, penalties, and public embarrassment for FDA-regulated companies. And if managing your own records isn’t challenging enough, FDA holds you equally responsible for ensuring the quality of records generated by your suppliers, contractors, and vendors.

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  • Establishing and Operating an Effective GMP Auditing Program

    14 April, 2017 Robert L. Dana

    By Robert L. Dana

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  • How to Solve Top Five Document Management Challenges - GxP Lifeline

    14 April, 2017 MasterControl

    Document management is such a fundamental need in any FDA compliance effort, and it poses so many challenges, that we could easily discuss the ?top 20? or more problems that plague life science companies. But in the interest of space, here are the top five document control issues that most companies complain about and some tips on solving them.

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  • GxP Lifeline - Five Top Deviation Management Challenges

    14 April, 2017 MasterControl

    MasterControl Deviations Management Software helps ensure FDA compliance.

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  • Essential Elements of Effective CAPA Systems - Death by CAPA

    14 April, 2017 Ken Peterson, PathWise Inc.

    The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.

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  • Introduction to the eCTD - GxP Lifeline

    14 April, 2017 MasterControl

    The CTD (Common Technical Document) was proposed by the ICH working committee (the International Conference on Harmonisation) back in the early 1990s and finally agreed upon in November 2000. Its purpose was to provide life sciences companies with a common structure for registering drugs for human use to the regulatory agencies. The FDA was the first agency to adopt the CTD as a common structure for receiving product registrations from companies. Although the CTD submissions were initially deliv

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  • Five Things to Expect from a Compliance Software Vendor - GxP Lifeline

    14 April, 2017 Jim Murrin

    The advent of JetBlue's Customer Bill of Rights has increased public awareness about the consumer's fundamental right to get his or her money's worth. Whether you're buying an airline ticket or a car, you should know what you can expect from the seller.Let's apply this concept to life science companies purchasing software for managing the content derived from their GxP processes. In the February issue of this newsletter, we discussed the things that a life science end user should consider, namel

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  • Solutions for Most Common Change Control Issues Face by Life Science Companies

    14 April, 2017 MasterControl

    1. Inefficient System of Communication. You need effective communication to be able to implement change properly. For a company that relies on a paper-based or partially electronic system, this is the typical scenario: Once or twice a week, up to 15 people who constitute the Change Control Board meet for two hours each time to discuss engineering and other document changes. Before and after each meeting, documents are routed using the inter-office mail system or via e-mail. The problem wi

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  • How to Solve the Top Five Batch Record Challenges

    14 April, 2017 Oliver Wolf

    By Oliver Wolf

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  • Shook Up Without QA: A Brief Look At The 24th Annual SQA Meeting

    14 April, 2017 MasterControl

    Another well-attended and enlightening annual meeting of the Society of Quality Assurance (SQA) was held on April 20-25, 2008 in Memphis, Tennessee. In keeping up with the theme of "All Shook Up Without QA," the meeting offered the state-of-the-art experience in promoting and advancing the principles and knowledge of quality assurance essential to regulated research in the human, animal and environmental health sciences. For those that have never attended an SQA annual meeting, this year's meeti

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  • How to Solve the Top Five Complaint-Handling Challenges

    14 April, 2017 MasterControl

    Consumer complaints are at the heart of every product recall. Whether it's Merck's voluntary recall of the pain medication, Vioxx, or the Class I recall of counterfeit LifeScan blood glucose test strips, chances are both actions stemmed from complaints.The reporting of side effects or adverse events is incorporated in FDA regulations. The agency operates MedWatch, a safety information and adverse-event reporting program that allows health-care professionals and the public to report serious probl

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  • Adopting Technology In The Life Science Industry Article

    14 April, 2017 Curt Porritt

    By Curt Porritt

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  • 21 CFR Part 11: What's New? GxP Lifeline

    14 April, 2017 MasterControl

    The anticipation over a new 21 CFR Part 11 and a new companion guidance for compliance is waning because of persistent speculation within the industry that the FDA is not ready to release the documents until later this year or perhaps next year.Ever since the agency issued a nonbinding guidance on Part 11's scope and application in 2003, the industry was rife with talk about the need for a better guidance, and perhaps a new and better regulation altogether. Four years later, there is neither a n

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  • FDA Chooses MasterControl's QMS Article

    MasterControl

    MasterControl, a global provider of quality management systems (QMS), is pleased to announce that it has been selected as the QMS software provider for the U.S. Food and Drug Administration (FDA). More specifically, the Office of Regulatory Affairs (ORA) within the FDA has contracted with MasterControl through its partner, i4DM.

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  • For Life Science Professionals - Is Your Executive Management Involved with Quality?

    31 January, 2011 Christine Park, Christine Park & Associates

    Note: Though this article references 21 CFR Part 820, it is applicable to any company that is striving for more quality-system input and involvement from management.

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  • End-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals

    31 January, 2011 Stephen F. DeAngelis, Technology and Supply Chain Sector Entrepreneur, Enterra Solutions, LLC

    This article was originally published in the Enterra Insights Blog, which is sponsored by Enterra Solutions, LLC.

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  • Effective Nonconformance Management Key to FDA and ISO Compliance

    13 April, 2017 Jason Clegg, Marketing Director, MasterControl, Inc.

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • Dietary Supplements Testing

    13 April, 2017 Sharon Phillips

    As noted in previous articles (see May 2008 issue of GXP LifeLine for example), the primary purpose of the final FDA Rule on Dietary Supplements (21 CFR Part 111) is to assure that current good manufacturing practices (cGMP) are followed and documented. The final FDA Rule on Dietary Supplements does not require manufacturers of dietary supplements to test their products before they are marketed.

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