Showing items tagged as life sciences

  • Key Regulations & Initiatives that Modernized Compliance for Life Science Companies

    4 October, 2016 by Cindy Fazzi, Editor, MasterControl Insider

    Not too long ago, regulatory compliance meant color-coded stamps for various documents, gigantic cabinets for storing files, and truckloads of paper documents for FDA submissions. The advent of 21 CFR Part 11 signaled the movement toward automation. It’s one of 16 regulations and initiatives that helped modernize the compliance process for life science companies.

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  • OMG! The FDA Is Keeping Up With Kim Kardashian, Too

    28 August, 2015 Alex Butler, Product Manager, Life Science Applications (LS APPs), MasterControl

    Love her or hate her, reality-star Kim Kardashian knows how to get our attention. Whether she’s trying to break the Internet with risqué photos or agonizing over which Rolex to wear, people are watching. Kardashian boasts more than 34 million Twitter followers; 26, 074, 878 likes on her Facebook fan page; and 42 million Instagram followers. Forty-two million! That’s how many people may have seen her infamous July 19 Instagram post praising the morning sickness drug Diclegis® that landed her and drug maker Duchesnay in hot water with the FDA. “Kim Kardashian’s greed finally got the better of her,” the author of one op-ed piece for the popular U.K. tabloid the Mirror gleefully exclaimed.1 I’m not so sure. Perhaps Kim Kardashian is smarter than we think.

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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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  • 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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