• 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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  • Until April 2011, the FDA is taking comments regarding the recently issued PGx Draft Guidance

    8 March, 2010 MasterControl

    Until April 19, 2011 FDA is taking comments regarding the recently issued PGx Draft Guidance. The guidance documentation was written to provide recommendations to drug manufacturers regarding how genomic information can be used during the drug development process. According to GenomeWeb News the draft's primary purpose is "...helping drug developers evaluate how human genomic variations can affect the way drugs function in different people and how they can cause varying clinical responses."1 Als

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  • The Effects On Biological Products From Severe Weather - Did You Know?

    MasterControl

    The tornadoes and hurricanes that accompany summer often bring unexpected changes to life science workplaces. Seasonal power failures and floods can play havoc with biological products under study or in production in laboratories and other facilities.

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  • Supplier Audits in Pharmaceutical Environments - Did You Know?

    5 September, 2017 MasterControl

    What is it that pharmaceutical manufacturers should do every 12-18 months? According to a recent FDANews update, pharmaceutical manufacturers should "conduct audits every 12 to 18 months for suppliers of critical materials," "perform a risk analysis to identify areas of concern for monitoring," and "negotiate quality agreements before signing a contract with a new supplier."

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  • New FDA Report Reveals Barriers to Medical Device Quality

    7 December, 2011 MasterControl

    You may know that the volume of adverse reporting is on the rise. Did you know that recalls have risen slower than adverse events but have matched industry growth? And that in general, critical, life-sustaining devices are responsible for a growing share of adverse event reports, but not of recalls?

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  • Device Makers Can Use New FDA Database

    7 November, 2010 MasterControl

    There is one thing that every device manufacturer knows: it can be very difficult to effectively manage and support suppliers.

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  • New FDA Guidelines for Informal Medical Device Application Review - Did You Know?

    14 April, 2017 MasterControl

    Since more resolute performance goals have been set forth by the agency after the 2007 FDA Amendment Act, increased interaction during the review process between the FDA and life science industries has become an issue of note. According to the guidance, interactive reviews will facilitate increased informal interaction between the FDA and applicants and enable the exchange of vital scientific and regulatory information. To view the guidance, follow the link below.

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