• 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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  • The Effect of Quality Management on Compliance with European Union GMP Standards

    14 April, 2017 James Jardine

    How crucial is Europe to the global pharmaceutical market? First consider that Europe, North America, and Japan comprise 80 percent of the world's pharmaceutical market. Take that statistic in conjunction with the estimation from Report Buyer, a renowned market research firm, that the Western European market alone is expected to grow to $245.3 billion by 2012.

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  • GMP Training Exams - Did You Know?

    14 April, 2017 MasterControl

    In the FDA environment, adequate and continuous personnel training is essential in manufacturing safe, reliable, and high-quality products. Companies are required to implement and document GMP training to make sure that their personnel know how to perform their duties within company and industry guidelines. What better way to prove employee competency than through exams? When the FDA investigator comes, your employees should be able to demonstrate their skill level in their daily work, but exam

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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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  • Increased Disclosure of Food, Drug and Med Device - Did You Know?

    14 April, 2017 MasterControl

    Did you know that democratic legislators are vying for the increased disclosure of food, drug and medical device information?

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  • eCTD Specification Document (Version 3.2) Provides Recommendations - Did You Know?

    14 April, 2017 MasterControl

    File names should only use lower case characters and hyphens and should have only one file extension that indicates the format of the file.  You should avoid using what are known as “special characters” in your file names such as punctuation, underscore, spaces, or other nonalphanumeric symbols.  The only exception to this is regarding SAS transport files to the FDA, in which they will allow underscores.  Internal corporate naming conventions that include date or

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  • Whats in Your Toolbox? Choosing the Right Tool for Quality Improvement

    14 April, 2017 Bonnie Messinger

    Quality improvement tools are like any other tool set. Each basic tool has a brood of new and improved versions intended for increasingly specialized applications. A seasoned facilitator may have literally hundreds of tools at her disposal. However, finding a few basic favorites and learning them well is sufficient for most applications.

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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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  • FDA's Sentinel System - Did You Know?

    14 April, 2017 MasterControl

    The Food and Drug Administration's (FDA) Sentinel Initiative was launched May 2008 in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA).1 The FDAAA provisions mandated that the FDA take the lead in developing an electronic surveillance system to increase the agency's capacity to monitor regulated medical products on the market. Although the FDA has a number of systems already in place to track adverse events and product problems, these monitoring tools all represent a p

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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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  • 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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  • 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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  • 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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  • 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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