Showing items tagged as data integrity

  • Novartis’ Data Manipulation Case a Cautionary Tale for Transparency Through Digitization

    12 September, 2019 by Mike Rigert, Staff Writer, MasterControl

    Poor data integrity and data mismanagement can be costly for life science companies, delaying their products from getting to market, and in some cases, resulting in civil and criminal penalties. The Swiss pharmaceutical manufacturer Novartis is currently under fire after the FDA said the company falsified testing data prior to the release of its drug Zolgensma. It’s a cautionary note about why now, perhaps more than ever, greater transparency is needed in data management.

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  • Study: Effluvial Lodging for Mice Negatively Impacts Data Quality

    20 June, 2019 by David Jensen, Staff Writer, MasterControl

    Researchers at the University of British Columbia (UBC) discovered that laboratory mice are not only biologically similar to humans, they also have similar aesthetic attributes. A recent study revealed that mice actually don’t like to sleep in sewage waste. Aside from affirming that mice might have some level of dignity and social grace, the study suggests that consistently exposing mice to “chronic averse stimuli” can negatively affect research data.

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  • 7 Key Elements to Data Security and Quality Control for Pharma Labs

    28 May, 2019 by Armando Coronado and Vidhya Ranganathan, Consultants, Sequence

    Due to a growing number of U.S. Food and Drug Administration (FDA) CGMP violations involving data integrity, pharmaceutical companies are looking for ways to improve good manufacturing and lab practices. This article looks at a number of options pharma has to enhance data integrity and to ensure the safety, efficacy and quality of its products.

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  • Rise in Data Integrity Violations Prompts FDA Guidance on Data Handling

    4 April, 2019 by David Jensen, Staff Writer, MasterControl

    Noticing an increase in violations of current good manufacturing practices (CGMP) regarding data integrity, the U.S. Food and Drug Administration (FDA) drafted a question-and-answer-based guidance to address some of the frequently asked questions and to clarify the role of data integrity in drug manufacturing.

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