GxP Lifeline

 

  • Cut through the Clutter: Simplifying Regulatory Compliance

    29 April, 2015 David R. Butcher, Marketing Communications, MasterControl

    For any business, the process of getting a product to market – from concept initiation through release – is often long and arduous. For manufacturers that must navigate the maze of regulatory red tape, hoops and hurdles, the process of bringing an innovative product to market can be even more punishing and the stakes even higher: one wrong step can stall or completely derail the entire product development effort, giving competitors a major advantage in the race to market. race to market.

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  • MasterControl Revs Up Improvement

    28 April, 2015 Craig Gygi, Executive VP Operations, MasterControl

    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 in every geography, companies have figured out 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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  • Risk: 2015’s Most Valuable Player?

    23 April, 2015 Marci Crane, Marketing Communications, MasterControl

    For quality professionals, and especially those in quality management, there are often quality themes that seem to emerge from year to year. In 2000, the theme of process-driven quality was certainly salient and other various themes--though not necessarily new to quality management—seem to stand out as each year passes.

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  • Fewer Donor Hearts Used

    21 April, 2015 Sheila Yu, dailyRx News

    As the waiting list for heart transplants has grown longer, fewer hearts have become available for transplantation in the US in recent years.

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  • Your Biggest End-User Training Problem—Solved!

    16 April, 2015 Donna Cline, Senior Instructional Design Specialist, MasterControl

    According to Forbes magazine, the global e-learning market is projected to reach $107 billion in 2015.(1) What’s driving the demand? Employees work in offices (and at home) all over the globe. Traditional face-to-face instructor-led training (ILT) or classroom learning is often too impractical for today’s geographically dispersed workforce. E-learning, also known as online or Web-based learning, solves what is arguably the biggest challenge training coordinators face: How do I reach my scattered workforce?

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  • 5 Practices for Managing Change When ISO 9001: 2015 Arrives

    14 April, 2015 Terrance Holbrook, Senior Product Manager, MasterControl

    Quality management system (QMS) standard ISO 9001:2008 is about to undergo some significant changes soon, with the new ISO 9001:2015 due to be published later this year. As a result of proposed fundamental changes to the structure and contents of the standard, this revision will be important to organizations with, or seeking, ISO 9001 certification and those implementing ISO 9001 systems.

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  • Regulatory Tools Go UFO: Useful, Free & Online

    7 April, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    Despite your best efforts, if you’re active in social media, you’ve been drawn into pointless conversations.  Indeed, that’s why many people stay away.  But if you can tolerate a little noise, I’ve found that the fruitful far outweighs the fruitless.  Case in point:

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  • Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences

    2 April, 2015 Patricia Santos-Serrao,MasterControl's Market Segment Manager, Global Pharmaceutical, Blood & Biologics

    When describing the role of Regulatory Operations I have found that one of the best analogies of their role and responsibilities is to be the “air traffic control tower for interactions between a life sciences organization and a regulatory authority.” By no means is that their only role but it is an essential role that involves constant communication with various parties both internally as well as externally. Regulatory Operations personnel coordinate resources and documentation essential for filing of global applications such as INDs, NDAs, BLAs and MAAs for pharma/biotech organizations and of 510k and PMAs for medical device organizations.

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  • Why Do You Do What You Do?

    31 March, 2015 Jon Beckstrand CEO, MasterControl Inc.

    Have you ever asked yourself why you do what you do? When you find yourself buried in quality procedures and SOPs, or embroiled in a heated meeting over incomplete CAPA tasks, do you ever question the meaning of your work?

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  • 3 Keys to Driving Collaborative Growth in Life Sciences

    26 March, 2015 James Jardine, MasterControl

    A recent study by LNS Research shows that life sciences companies are facing an unprecedented demand for better and safer products. Results from LNS Research’s surveys of industry executives indicate the pressures life science organizations are facing and the new technologies and processes they are employing to meet rising needs.

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  • Closed-Loop Quality Management: Connecting the Value Chain

    24 March, 2015 James Jardine, Marketing Communication, MasterControl

    An increasing number of leading organizations are learning that quality management must extend far beyond the manufacturing environment, according to a recent eBook co-sponsored by LNS Research and MasterControl. The research collected in the eBook indicates that market leaders are beginning to implement a closed-loop approach to quality that bi-directionally unites people, processes, and data across the value chain. This approach connects quality from design and procurement stages all the way through manufacturing and service. Other findings in the book show that Enterprise Quality Management Software (EQMS) is vital to the establishment of an effective closed-loop system that can help a manufacturer better control costs, compliance, and risk.

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  • Did the Titanic Follow ISO 31000 Risk Management Guidelines?

    19 March, 2015 David Patrishkoff, President, E3

    ISO 31000 (Risk Management) and its supporting publications encompass an impressive and useful "to-do" list of risk management guidelines to create and protect the value of an organization. However, if an organization selectively pursues some of the ISO guidelines and ignore others, highly undesirable events and tragedies can occur.  This is what happened with the Titanic.

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  • Infographic: How Evolved Is Your Quality Management System?

    17 March, 2015 Lisa Weeks, Marketing Communications, MasterControl

    Quality management systems (QMSs) have steadily evolved over time. The sophisticated systems of today are a far cry from the primitive paper-based systems of the past. They're faster, leaner, greener and just plain better. How did we get to where we are today? And is your company at the top or bottom of the QMS evolutionary chain? View the infographic, or keep reading to learn more about the evolution of the enterprise QMS.

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  • The Journey to Supply Chain Excellence

    12 March, 2015 Ed Rausch, VP of Global Marketing, Elemica

    Some goals haven’t changed. Businesses in 2015 still have the common pursuit of growing revenues, profits, and market space, and leading companies are relying on building collaborative relationships in their extended supply chains to meet these goals in a responsible and sustainable way. Building powerful and more intimate relationships, extending across a critical mass of trading partners, leads to continuous improvements in company performance, agility, and differentiation.

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  • Data Integrity Starts With User Access

    10 March, 2015 Jamie Colgin, Colgin Consulting

    In my next few blog posts, we'll be covering user access and how it can impact data integrity. For starters, let's explore the Principle of Least Privilege. What is it?  What happens when it's violated? Finally we'll map out five actions you can take to protect your company.

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  • 3 Levels of SQF Certification

    5 March, 2015 Sam Lewis Associate Editor, Food Online

    SQF Certification is an assurance, assessment, and audit program that can increase your company’s marketability, domestically and globally.

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  • FDA Launches Drug Shortages Mobile App

    4 March, 2015 Christopher Kelly, FDA CDER Trade Press

    Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.

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  • After Five Years, Compliance-First Approach is Still Obstacle to Improving Product Quality

    3 March, 2015 Dan Matlis, Founder and President, Axendia

    Five years ago we looked at the road blocks to improving product quality.  In the intervening years there has been little change by most Med-Tech Companies.  The matter of Product Quality vs. Compliance recently has been given a push toward the Quality side by efforts made by the FDA.  The four-part whitepaper reveals how aligning process improvement initiatives with technology platforms and an integrated approached to product quality can help Med-Tech organizations improve produc

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  • Four Reasons to Automate SOP Management in FDA and ISO Environments

    26 February, 2015 David R. Butcher, Marketing Communications, MasterControl

    To maximize efficiency and safety, successful companies across all industries employ effective standard operating procedures (SOPs). For companies doing business in regulatory environments, effective SOP management is imperative. An electronic SOP management system can dramatically improve SOP management in at least four key areas.

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  • 7 Document Management Blunders that Jeopardize Compliance

    25 February, 2015 James Jardine, Marketing Communications, MasterControl

    Achieving regulatory compliance without any document management slipups is like walking through a dog park without getting your shoes messy. It seems nearly impossible to find a safe route to your compliance destination and there are countless potential mistakes you can make at any step along the way. Since the path to compliance is narrow and treacherous, here are seven examples of common document management mistakes that can jeopardize your compliance and a few ideas on handling these types of problems.

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