• 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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

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

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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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  • 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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  • GxP Lifeline - Five Top Deviation Management Challenges

    14 April, 2017 MasterControl

    MasterControl Deviations Management Software helps ensure FDA compliance.

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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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  • Establishing and Operating an Effective GMP Auditing Program

    14 April, 2017 Robert L. Dana

    By Robert L. Dana

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  • 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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