• Supplier Quality Agreements: Benefits to You and Your Supplier

    10 May, 2012 Betty Lane, Founder and President, Be Quality Associates, LLC

    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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  • Single Sourcing of Critical Components: Strategies for Optimization

    28 November, 2012 Peter Knauer, Partner Consultant, MasterControl Quality and Compliance Advisory Services

    The increase in virtual or under-resourced biomedical companies has resulted in a dramatic shift in outsourcing components and supplies. Larger companies are also joining this outsourcing trend. Even more profound is the increasing reliance on single-sourced suppliers, particularly for critical components. While this can be an effective way to reduce the cost of goods and improve efficiencies, there are some significant risks associated with this practice. This article examines these risks and a

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  • New Draft Guidance on Quality Agreements: No Passing the Buck on CGMPs

    10 August, 2013 Cathy L. Burgess, Donald E. Segal and Guillermo Cuevas,Alston & Bird LLP

    Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with

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  • Managing Your Medical Device Suppliers

    12 June, 2013 Michelle Bonn, President, Expedient Trade LLC

    Since the medical device and drug industries have transitioned into global market players, the concept of “virtual manufacturing” has grown in popularity and necessity. What exactly is a virtual manufacturer? In the eyes of the FDA, virtual manufacturing applies to any medical device or drug company that outsources any of its manufacturing functions.  This includes, design, packaging, sterilization & regulatory functions.

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  • How to Build a Strong Supply Chain Team

    30 October, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    In today's fiercely competitive global market, finding good suppliers that help create efficiencies, reduce cost, and support compliance efforts is critical to the success of manufacturers in regulated environments. Let's say you have found excellent suppliers, the question is: How do you maintain control over your suppliers and also keep good relations with them?

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  • Ways to Ensure Supplier Compliance

    15 May, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Your suppliers are critical to your success. They can increase your company's efficiency-in terms of time, cost, and quality. But in some cases, suppliers can put their clients in hot water; this is especially true if those clients are regulated companies.

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  • Why You Need to Go Beyond Risk Analysis

    30 October, 2012 Richard Vincins, Vice President of Quality Assurance, Emergo Group

    Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team itself identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk ass

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  • Uncertainty and Risk: Providing Value for Stakeholders

    10 July, 2013 Greg Hutchins, Principal Engineer, Quality + Engineering (Q+E)

    In Against the Gods: The Remarkable Story of Risk, the author says the mastery of risk is the foundation of modern life and is what divides modern from ancient times. By consciously or unconsciously calculating probabilities, auditors make intelligent decisions about business processes. First let’s look at a few definitions of risk.

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  • Regulations Vary Worldwide but Risk Management is Common Demoninator

    17 July, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    To compete in today's global market, regulated companies must comply with innumerable requirements, directives, and standards coming from regional, national, and international bodies. While these requirements vary based on industry and the regulatory body involved, they do have a common denominator—emphasis on risk management.

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  • Transitioning from an FMEA Risk Analysis to a Total Risk Management System

    31 January, 2013 Richard Vincins, Vice President, Quality Assurance Consulting, Emergo Group

    Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team themselves identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk

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  • Biotechnology Article

    28 May, 2015 MasterControl

    The MasterControl quality management system is a flexible system since it can be constructed from a variety of individual quality control/quality assurance solutions.

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  • MasterControl Again Named to Software Magazine’s 31st Annual Software 500

    8 October, 2013 by Software Magazine

    MasterControl Inc. recently announced its inclusion in Software Magazine’s Software 500 ranking of the world’s largest software and service providers, now in its 31st year. This is the fifth year the company achieved this recognition.

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  • When Good Teams Go Wrong

    17 July, 2012 by Ruth Dubinsky, MS, President, Clarity Consulting

    How's your team doing? Are you hitting your targets without leaving "dead bodies" in the wake? Do you sense trust, commitment, and accountability from your fellow team members?

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  • SPC vs SQC: The Strategic Difference

    1 May, 2013 Jason Orloff, Statistical & Engineering Consultant, Pharmstat

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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  • Quality Misconceptions

    4 January, 2011 Jennifer Stepniowski, Special Project Manager, Pro QC International

    For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality-related issue and are looking to quickly extinguish the fire and prevent recurrences. Or they may simply want to reduce their overall risks—and costs—by incorporating a specific quality initiative.

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  • Developing a QMS: Should You Buy or Build?

    11 December, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.

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  • Avoiding Remediation with a Good QMS

    15 May, 2013 Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.

    Many companies will try to resolve compliance actions by the Food and Drug Administration (FDA) through the use of an electronic document management system (EDMS) approach that is typically post mortem. This is risky business at two critical levels. First, no EDMS approach will replace the operation of a comprehensive quality management system (QMS) that describes the integration of necessary GxP (compliance) driven quality processes. Secondly, the response will need to have a litany of justif

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  • Using History to Predict the Future of Quality

    10 July, 2013 Tim Donaldson, President, Donaldson Group, Inc.

    Predicting the future is fool’s play---think Edsel, Nostradamus, even Chicken Little. But if you or your organization is wrestling with what direction to take your quality programs and your entire organization, perhaps a brief look at history will aid in developing your future strategies and culture of quality.

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  • Top 10 World Quality Month

    8 October, 2013 MasterControl

    Did you know that November is World Quality Month?  You still have a few days left to create your own list of top ten actions you’ll take to improve the quality of your work.  Here are a few suggestions:

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  • MasterControl Revs Operational Excellence Using Six Sigma

    24 April, 2013 Craig Gygi, Executive Vice President Operations, MasterControl, Inc.

    The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and every geography, companies have determined that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

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