• The Nine Elements of Lean Configuration

    18 September, 2014 José Ignacio Mora, Owner, Atzari Enterprises, L.L.C.

    The allure of finally terminating your paper quality management system (QMS) feels very liberating. You can see the excitement in everyone's eyes during the new QMS software presentation.  Gone will be the days of paper engineering change notice---everything will be circulated and approved electronically and finally everyone will have time to do their jobs. They can hardly wait to tell their cubicle buddies about the new world they will soon live in.

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  • Communicating Priorities to Your Employees

    16 September, 2014 Curt Porritt, SVP, Marketing, MasterControl Inc.

    Needless to say, if managers don’t understand corporate priorities, they can’t communicate them to employees. Entire departments may pursue the wrong priorities, causing stra­tegic corporate plans to become less effective. I’ve seen a lot of this. Likewise, if managers understand the priorities, but have not communicated them well to their departments, the results can be the same. And if employees are left to themselves to decide what the priorities are, not only are the efforts of your teams unlikely to match corporate goals, they probably won’t even match each other. You will likely have employees working in different directions, even within the same departments or even on the same projects.

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  • INFOGRAPHIC: Closed-Loop Quality Management and the Cost of Inaction

    11 September, 2014 David R. Butcher, Marketing Communications, MasterControl

    In today’s global manufacturing environment, continuing to rely on outdated, siloed quality management technology comes at a cost that many regulated companies simply cannot afford, new research indicates. That is why leading manufacturers are taking quality management further, leveraging EQMS to develop closed-loop quality processes that track quality throughout the value chain.

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  • 6 Best Practices for Enterprise Solutions Implementation

    9 September, 2014 Kevin Ash, Senior Vice President of Services, MasterControl

    Investing in a powerful software solution can be extraordinarily valuable to your organization, yet the effort is wasted if it is not implemented effectively. To help ensure a smooth and successful implementation process, consider these six best practices.

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  • Choosing the Right Drug Name: How to Increase Your Chances for Approval

    4 September, 2014 Susan M. Proulx, President, Med-ERRS

    The pharmaceutical industry is all too familiar with how exceedingly challenging it can be to achieve a viable trademark that is accepted by the health authorities, especially if obtaining a global mark is the end goal. Over the past few years, health authorities in several countries have been developing their proprietary name guidances. In the last six months alone, both Health Canada and the FDA released guidances pertaining to proprietary name development – Health Canada’s proprietary name guidance was finalized and FDA released its first-ever initial draft guidance on the topic of name selection and development. Industry is now curious to learn how these guidances will affect their current trademark development and selection process and their trademark’s chance of approval.

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  • FDA Issues New Q&A On Data Integrity

    2 September, 2014 Jamie Colgin, Colgin Consulting, Inc.

    Recently FDA published a new set of seven questions and answers. Three questions cover data integrity and e-signatures. While the Q&A target GMP, there are lessons to be learned for all of us:

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  • What You Don't Know About the Drug Supply Chain Security Act (DSCSA) Implementation Plan

    28 August, 2014 Peter Knauer, Senior QCC Consultant, MasterControl Inc. and Moj Eram, Regulatory Consultant

    This article discusses the implementation aspects of the new Drug Supply Chain Security Act (DSCSA), which was signed into law (Title II of Public Law 113-54) by President Obama on November, 27, 2013. The Act intends to build a comprehensive, standard electronic and interoperable system to identify and trace prescription drugs in the US.

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  • Regulatory Records Primer Part 2: Decoding the Requirements for Pharmaceutical Manufacturers

    26 August, 2014 Les Schnoll, Quality Docs, LLC

    In Part 1 of the Regulatory Records Primer (Decoding the Requirements for Medical Device Manufacturers), I discussed the general requirements and thought processes undertaken by the FDA with respect to regulatory records.  While the drug side has not yet “evolved” to using a quality systems approach to the regulatory requirements, the same basic process holds true.  Following is a discussion on the regulatory records required to be maintained by manufacturers of finished drug products.

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  • Regulatory Records Primer Part 1: Decoding the Requirements for Medical Device Manufacturers

    21 August, 2014 Les Schnoll, Quality Docs, LLC

    The Quality System Regulation (QSR) is premised on the theory that the development, implementation, and maintenance of procedures designed to carry out the requirements of the regulation will assure the safety and effectiveness of medical devices. Therefore, it is easy to see the importance of the records required to document the implementation of those quality system procedures. One of the basic themes of the Quality System Inspection Technique (QSIT) (used during inspections of medical device manufacturers) is the “Establish Test.” The QSR requires many procedures to be “established” and defines “establish” as “define, document (in writing or electronically), and implement.”

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  • Industry Expertise Sets MasterControl Apart from Competition

    19 August, 2014 by James Jardine, Marketing Communications, MasterControl

    Over the past two decades, MasterControl has flourished to become one of the world’s foremost providers of quality management software solutions and services. But innovative technology is not the only driver behind the QMS leader’s prosperity. In fact, it is the industry experience of MasterControl’s knowledgeable personnel that is the guiding force that propels the company’s continued growth worldwide.

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  • Medical Device Development: Thinking Globally, Acting Locally

    14 August, 2014 by Timothy Blair, Director, Global Business Development, NAMSA and Seth J. Goldenberg, PhD, Senior Principal Scientist, NAMSA

    The global healthcare and healthcare service market will maintain steady growth due in large part to an aging population that is living longer and to improved healthcare services in emerging markets that include China, Brazil, India, Japan, Israel, and South Korea, among others. It is interesting to note that countertrends seem to be developing in the medical device space; for example, hospital utilization of medical devices has slowed significantly, reimbursements continue to tighten, and there was a first-time global decrease (5%) in US premarket approvals (PMAs) in 2012, a trend that continued into 2013. There were also fluctuations in investor healthcare spending across 2012, drops in mergers & acquisitions deal value and deal counts, and a device tax that is adding to the squeeze.

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  • Certification: Is It Worth the Hassle?

    12 August, 2014 by Lisa Weeks, Marketing Communications, MasterControl

    In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process.

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  • Version 11 of MasterControl Features More New Enhancements than Any Previous Release

    7 August, 2014 by James Jardine, Marketing Communications, MasterControl

    The recently released version 11 of MasterControl software dramatically accelerates customers’ ability to deliver life-changing products to those who need them most.

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  • 5 Ways to Cut Medical Device Development Time with Embedded Design Teams

    5 August, 2014 by Chris Hammond, Director of Insight & Innovation, Kaleidoscope and Sean J. Barnett, MD, MS, FACS, FAAP, Chief Medical Officer, Kaleidoscope

    For medical product development, the rigors of input gathering and iterative concept testing may slow down innovation process and subsequently increase costs. Building on user-centered design principles, creating an Embedded Design Team with clinicians and design professionals in a co-creation atmosphere provides a revolutionary way to drive speed to market.

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  • Questions All Auditors Should Ask: The Use and Misuse of Audit Checklists

    31 July, 2014 by Laurie Meehan, Polaris Compliance Consultants, Inc.

    There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: “Why?” So how can you develop the best checklists possible and avoid relying on them too heavily?

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  • Current Issues in Medical Device Risk Management

    29 July, 2014 by Edwin Bills, RAC Consultant

    Medical devices have been developed with some requirements for product safety since the implementation of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act.  Initially FDA required manufacturers to submit information related to safety as part of the 510(k) premarket notification process, providing comparative data on predicate devices versus the device under consideration.  In the more rigorous Premarket Approval (PMA) process, more detailed safety inform

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  • How to Conduct Better Effectiveness Checks and Management Reviews within Your CAPA Process

    24 July, 2014 by Lisa Weeks, Marketing Communications, MasterControl

    In the final segment of a three-part QEM/CAPA webinar series, quality expert Ken Peterson discusses the importance of effectiveness checks within the CAPA process. He also explains the difference between process verification and process validation, and why knowing which process to use (and when to use it) is paramount to a successful CAPA methodology. Peterson closes the webinar by summarizing the current models and best practices being used in management review, data collection, and charting to enhance CAPA decision making in all areas of your business. This is a summary of that discussion. If you wish to view the webinar in its entirety, please click on the link provided at the end of the post.

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  • How the New FDA Final Rule and Guidance on Electronic Submissions Will Impact Devicemakers

    17 July, 2014 by Lisa Weeks, Marketing Communications, MasterControl

    In February of 2014, the FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit initial and supplemental MDRs in an electronic format, rather than in paper form through Form FDA 3500A. The “Final Rule” will take effect on August 14, 2015, which means you have only 13 months to revise your MDR procedures to comply with the new requirements and to secure a production account for submitting eMDRs to the FDA. Will you be ready?

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  • 7 Steps to Respond to an FDA 483 Inspection Observation

    15 July, 2014 by Robert Packard, President, Medical Device Academy

    Responding in 15 days is one of seven steps on how to respond to an FDA 483 inspection observation. This blog post also includes advice from a former FDA investigator.

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  • Are You Ensuring Supplier Quality?

    8 July, 2014 Christine Park, Quality Architech, Christine Park & Associates

    "Everyone cares about quality. Just ask them. However, unless someone actively measures quality performance, you must question the commitment to improvement."

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