Showing items tagged as data integrity

  • Digitization Drives Results for Contract Manufacturers

    August 14, 2020 by Dale Thompson, Staff Writer

    Contract manufacturing and packaging organizations adopted MasterControl’s Manufacturing Excellence™ and saw significant results including increased production capacity, transparency for customer audits, and faster time to market. Read more about our customers seeing improvements in metrics that matter.

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  • Integration Is the Fast Lane to Data

    August 13, 2020 by Sarah Beale, Staff Writer

    A platform approach is the ideal way to handle software solutions across an organization. However, no software provider has every type of software that a company might need. That’s why integration platform as a service (iPaaS) is so vital. It bridges the gap between solutions and gives you better control over your data.

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  • 3 Advantages of a Data-Centric Quality Mindset

    June 4, 2020 By Dale Thompson, Staff Writer

    A seismic shift is coming to life sciences manufacturing, and that’s the move from documents to data. With a data-centric mindset, it’s possible to glean valuable insights while gaining a tremendous competitive advantage.

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  • How Harmonizing 21 CFR Part 11 and Data Integrity Delivers Higher Quality Products

    May 14, 2020 by David Jensen, Staff Writer, MasterControl

    Complying with the many record and data management requirements for 21 CFR Part 11 and data integrity can be daunting. In this article, Matt Brawner, data integrity subject matter expert (SME) at Sequence Inc., explains how companies can integrate Part 11 and data integrity processes to accelerate pathways to approval and deliver higher quality products to market.

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  • 2020 Life Sciences Industry Trends Point Spotlight on Data

    May 5, 2020 by David Jensen, Staff Writer, MasterControl

    Data is taking on a prominent role in advanced technologies, which is rapidly changing the dynamic of innovation across all industries. A new MasterControl trend brief, “2020 Trends in Quality Data Management and Integrity for the Life Sciences,” examines new life sciences industry trends that pivot around data and how they will impact regulated companies.

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  • In a Data-Driven Ecosystem, Don't Let Data Integrity Be Your Achilles' Heel

    February 27, 2020 by Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    Data has massive potential to revolutionize the life sciences for patients, regulators and for manufacturers. Yet at the same time, data integrity remains one of regulatory bodies’ biggest concerns. Learn what you can do to improve your company’s data integrity for regulatory inspections.

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  • Top 5 Pharmaceutical Manufacturing Trends in 2020

    February 20, 2020 by David Jensen, Staff Writer, MasterControl

    The pharma industry has been gathering no moss going into 2020. New pharmaceutical manufacturing trends have been rapidly emerging, accompanied by regulatory initiatives to help mainstream the innovations. A new trend brief from MasterControl discusses how the new trends will impact the pharma industry.

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  • Surge of Data Integrity Violations Irritating the FDA

    December 12, 2019 by David Jensen, Staff Writer, MasterControl

    Regulatory agencies cannot feasibly review every process and every bit of data at every regulated company. This is why they rely on manufacturers to provide complete and accurate information in their submissions. Still, data integrity violations remain the most common reason why medical product companies receive Form 483s and warning letters. For this reason, life sciences companies seeking regulatory approval for products should expect to ramp up their data management efforts.

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  • Top 5 Takeaways From IVT’s Data Integrity Validation Conference

    October 10, 2019 by David Jensen, Staff Writer, MasterControl

    The Institute of Validation Technology (IVT) recently hosted its fifth annual Data Integrity Validation conference (Aug. 14-15) in Waltham, Massachusetts. Subject matter experts from a variety of life sciences industries discussed critical aspects of data integrity and why it remains one of the most common inspection findings. This article highlights the valuable insights attendees gained about data management technologies and best practices.

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

    September 12, 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

    June 20, 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

    May 28, 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

    April 4, 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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