GxP Lifeline

 

  • 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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  • What Does 'Readily Available' Mean?

    7 November, 2010 MasterControl

    If you're familiar with 21 CFR Part 11 documentation, you're likely acquainted with compliance audits, electronic record integrity and approval processes. However, you may wonder what the term "readily available" means or what "instantly" refers to in the same context. According to Labcompliance News1, it's these phrases that keep regulated companies guessing.

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  • Did You Know...

    13 April, 2017 MasterControl

    That you can bring your team together in a virtual workspace for collaborative projects?

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  • UK MHRA Expects 98 Percent of Adverse Event Reports - Did You Know?

    31 March, 2010 MasterControl

    This mandate, as most medical device companies and MHRA regulators can predict, won't be simple but can be mad less complex with the newly introduced web-based reporting system that will soon be launched by MHRA and will include alert mechanisms.

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  • Did You Know?

    13 April, 2017 MasterControl

    St. Louis, Mo., as the number of organ transplants continues to increase throughout the world, so too are the number of organ transplant recipients developing skin cancer.

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  • Supplier Evaluations Differ from Audits in Scope - Did You Know?

    6 October, 2010 MasterControl

    EduQuest, a global team of compliance experts, recently answered a query regarding supplier evaluations and audits. You might find this to be of interest to your company as well!

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  • Phamaceutical Companies Have to Increase Reliance on Technology - Did You Know?

    13 April, 2017 MasterControl

    Compliance with FDA’s eCTD requirements need not be a burden for any size company when “renting” a solution is just as effective as making the investment to buy a solution.

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  • Increase End-to-End Trial Visibility - Did You Know?

    MasterControl

    According to a recent article in The McKinsey Quarterly entitled “Using IT to Speed Up Clinical Trials,” pharmaceutical companies spend hundreds of millions of dollars on clinical trials that may take up to seven years to complete. When pharmaceutical companies manage regulatory processes with the latest organizational technology, they are able to connect people with the documents and information they need when they need it. True end-to-end solutions for collecting, organizing

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  • Pharmaceutical Companies Identify Ways to Improve - Did You Know?

    13 April, 2017 MasterControl

    Single sourcing is a "write once, use many" approach to support the implementation of standard operating procedures (SOPs) and approved work instructions by allowing companies to enter their operating instructions into a single repository in order to automatically generate and update critical training and performance support materials.

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  • Multiple People Can Simultaneously Author a Word Document - Did You Know?

    MasterControl

    If you have different contributors to different sections of a document, everyone can still work on the same document without the usual process of someone having to maintain a central copy by cutting and pasting.

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  • Seven Pharmaceutical Companies Submit Joint Citizen Petition to FDA

    12 August, 2011 MasterControl

    A recent blog post written by attorney Dara Katcher Levy describes a citizen petition that was recently submitted by seven pharmaceutical companies requesting more clarification regarding off-label use manufacturer-communications. Specifically, as described by Levy, the companies wrote the petition to request more hard-fast rules and information regarding the following four types of off-label use manufacturer-communications:

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  • Eliminating 'Rogue' Document Issues - Did You Know?

    13 April, 2017 MasterControl

    Although, certainly, the prospect of securely managing a corporation's "controlled content" is a challenging proposition, especially in today's fast-paced, Internet environment, where electronic documents can be readily copied, distributed, and shared with virtually anyone, there is a solution, one that effectively defies even the most challenging of loopholes.

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  • Refusal to Accept Your Durg or Biologic Submission - Did You Know?

    MasterControl

    The eCTD format significantly cuts the cost and time of handling paper submissions, which can be equivalent to a semi-tractor full of paper, for regulatory authorities. It is the preferred format for regulatory reviewers in agencies in Europe, North America, and Asia. However, the eCTD format requires that the content be provided in fully-navigable Adobe Portable Document File (PDF) format to facilitate reviewer access to the content. This means that the document must have a hyperlinked table

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  • Technology Shift in Pharmaceutical Industry - Did You Know?

    MasterControl

    eCTDs for example are subject to change, and their continuous evolutions are promoting discussion in areas and initiatives such as RPS (Regulatory Product Submission). Companies focusing their efforts on "eCTD Tools" however may well find that they will need to re-invest - or possibly make drastic changes - every time a new standard is announced. This has already been witnessed with the move from the eNDA to the eCTD with the FDA - spurring new systems, new validation, new training and natural

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  • Document Review Process Can Reduce Document Review Cycles

    13 April, 2017 MasterControl

    Studies undertaken by PleaseTech's PleaseReview™ customers show that using collaborative document review can reduce document review cycles by as much as 65 percent. Take for example a 45-page document that has a document review cycle of 14 days. This 14-day period is made up of two seven-day periods. The first seven-day period consists of a five-day initial review followed by a two-day author consolidation. This period is followed by a second seven-day period (post comment consolidation) t

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