• FDA 483s Related to CAPA Issues - Did You Know?

    MasterControl

    Did you also know that your CAPA system relies almost entirely--at least initially--on the effective management of events such as nonconformances and deviations?

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  • Revision of EU Medical Device Directives - Did You Know?

    MasterControl

    There was frantic activity in Europe during May 2008 following the publication of a discussion document on the recast of the Medical Devices Directives that sparked a hot debate on the future of medical regulation in Europe. The recast did not reject the new approach but the European Commission are concerned--amongst many other items--about the consistency of notified body performance, market surveillance, and vigilance; however, these were also issues raised in the Revision of the Active Impla

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  • EU Will Use Electronic Solutions - Did You Know?

    MasterControl

    According to an article by José Manuel Barroso and Günter Verheugen (President and Vice President, respectively, of the European Commission), the commission's ongoing campaign "to cut the regulatory red tape" will use electronic solutions to boost international trade, saving European businesses 2.5 billion per year when fully operational.

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  • EU in Process of Establishing Biobank - Did You Know?

    MasterControl

    The Pan-European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) are in the process of creating the first European Union Research Infrastructure Consortium.

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  • The Help of Filtering Technology - Did You Know?

    MasterControl

    That you can give individual business units within your enterprise-wide system the flexibility to optimize their local processes with the help of filtering technology?

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  • 21 CFR Part 11 Requires Signatures - Did You Know?

    MasterControl

    That 21 CFR Part 11 requires electronic signatures to be linked to their respective electronic records?

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  • SAS Datasets in Version 5 - Did You Know?

    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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  • Electronic Submissions Must Be in eCTD Format - Did You Know?

    14 April, 2017 MasterControl

    The eCTD delivery mechanism streamlines the submission process by insuring that only the most up-to-date documentation is submitted. FDA will still allow hard-copy paper submissions but after December 31, 2007 other electronic formats (such as eIND, eNDA or hybrid eCTD/eNDAs) will no longer be accepted. All regulated organizations intending to send submissions electronically are urged to contact the FDA prior to preparing submissions using the eCTD specifications. Start a dialogue with the FDA a

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  • What Happens to eCTD Submissions - Did You Know?

    MasterControl

    When your eCTD arrives at the correct document room either on CD-ROM or into the Electronic Submission Gateway (ESG), the FDA will conduct a technical validation check on the submission to ensure that it can be opened, processed, and archived. In March of this year, the FDA issued the validation criteria to be used for their validation processes. Specifications for eCTD Validation Criteria version 1.0 outlines the items that will be checked in the eCTD and grades errors found by severity. If

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  • FDA Taking Comments Regarding PGx Guidance Document

    12 April, 2011 MasterControl

    This article was originally published by EduQuest in the March 2011 issue of EduQuest-ions & Answers.

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  • You Can Stop Wondering - Did You Know?

    MasterControl

    It's common for blood and/or biologics companies to struggle with the continuous task of training management. Even if a company has access to a team of highly trained personnel with the express duties of managing training (a company usually doesn't have access to this) training management is still a daunting task.

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  • DMS Can Speed Your Product - Did You Know?

    MasterControl

    Many pharmaceutical companies are realizing the benefits of DMS technology as it reduces a product's time to market by streamlining pre-clinical, clinical, commercialization and post-market phase documentation and by simultaneously reducing the cost associated with document administration and compliance.

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  • New Options for Improving Blood Transfusions

    18 October, 2011 MasterControl

    This story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Duke University Medical Center.

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  • Submitting Your eCTD to the FDA - Did You Know?

    MasterControl

    This will assist the automation of submission receipt by the FDA. These "fillable forms" can be found at the following webpage: http://www.fda.gov/opacom/morechoices/fdaforms/default.html.

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  • FDA Device Reclassification Could Save Industry Millions

    6 October, 2010 MasterControl

    All medical device manufacturers know the implications of the Class I, II and III device categories. If a device falls in the Class I category then the probable mantra is "Full steam ahead! Piece of cake!" Perhaps this "mantra" seems exaggerated but in comparison to Class II stipulations, Class I requirements do seem relatively simple.

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  • Medical Advice from the Past Now Seems Bizarre

    MasterControl

    With medical device and pharmaceutical professionals working hard to make a positive difference, it's often interesting, and even outright hilarious, to take a look back at the medical advice/remedies of the past and to realize how far life science professionals have progressed.

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  • Few Firms Are Measuring the Cost - Did You Know?

    MasterControl

    Onboarding "new hires" or moving employees from one assignment to the next effectively and efficiently is critical to a firm's productivity and profitability. Yet, few firms measure the cost or the return on investment, and fewer still are able to eliminate such costs.

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  • Physician Payments Sunshine Act - Did You Know?

    MasterControl

    The Physician Payments Sunshine Act, sponsored by Senators Charles Grassley (Republican - Iowa) and Herb Kohl (Democrat - Wisconsin) seeks to establish a national registry of industry payments to physicians, and impose strict rules for disclosing financial relationships between drug and medical device companies and doctors.

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  • Compliance Issues with 21 CFR Part 11 Standards

    6 October, 2010 MasterControl

    The inspections are due to occur "soon" according to an announcement made by FDANews and the inspections are expected to lead to 1) additional guidance, 2) an amendment(s) to the Part 11 regulatory text, or 3) both.

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  • Growth in Clinical Research - Did You Know?

    MasterControl

    As a result, quality management software is more essential than ever for handling the data and information that comes in from clinical trials.  Fortunately, there are software solutions to accommodate literally every budget that can be easily implemented.

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