Showing items tagged as data integrity

  • 2021-bl-sue-marchant-plenary_132x132

    2021: The Year for Insights Into Quality Data

    The new year might turn out to be just as unpredictable as the old. But, there’s one thing that we at MasterControl have full confidence in: Quality data will become more accessible and provide more insights than ever before.

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  • 2021-bl-ai-emerging-tech_132x132

    3 Practical Ways to Prepare for Pharma’s AI-Driven Future

    Think only big pharma companies with deep pockets can benefit from artificial intelligence and other advanced technologies? Think again. AI is the future of pharma, and nowadays companies of all sizes are starting leverage it to streamline quality processes. Learn the pragmatic steps you can take today to position your company to get good returns on AI investments.

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  • 2021-bl-investigational-device_132x132

    FDA’s IDE: Data-Centric Approach to Med Device Innovation

    An Investigational Device Exemption (IDE) is a regulatory option that allows an investigational medical device to be used in a clinical study in order to collect safety and effectiveness data. This article explains why medical device manufacturers would seek an IDE and how they apply for the designation.

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  • 2021-bl-data-driven-quality-model_132x132

    Adopting a Data-Driven Quality Model: Essential for Quality and Compliance

    Life sciences companies have long generated vast amounts of data as a byproduct of their processes for developing and manufacturing products. Quality is one area of the business that is particularly dependent on data. This article explains how companies are emerging as leaders in their industries by implementing a data-driven approach to quality management.

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  • 2021-bl-spectra-terms-explained_132x132

    Can I get a Translation Please? Tips to Ensuring Productive Communications with Regulatory Authorities, Part One

    Miscommunications can stall regulatory reviews and approvals. Avoid the frustration. In the first half of this two-part series, an expert shares her tips on how to prepare your regulatory submission. The trick is to “translate” your scientific and engineering outcomes so they can be easily understood by regulatory authorities.

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  • 2020-bl-coda-corp_132x132

    The Fundamentals of Immunization, Part 3

    Learn about the leading candidates in the race for safe and effective COVID-19 vaccines and therapeutics, as well as the technologies being utilized to shepherd us to the end of this pandemic.

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  • 2020-bl-matt-brawner-qa-part2_132x132

    An Expert Explains Data Integrity and Organizational Excellence – Part Two

    Data integrity is an integral part of organizational excellence. An expert explains why companies need to align their efforts with customer needs, one of which is adhering to all applicable regulations. Common mistakes around 21 CFR Part 11 are explored along with ways to avoid them.

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  • 2020-bl-matt-brawner-qa_132x132

    An Expert Explains Data Integrity and Organizational Excellence – Part One

    Data integrity is closely related to organizational excellence. An expert explains best practices and mistakes to avoid.

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  • 2020-bl-things-go-sideways_132x132

    What to do When Things Go Sideways (And How to Recover)

    When you experience an event such as a product recall or low production rates, resolving these issues can be challenging. Your best bet is to have a road map that helps you get to the root of the problem and recover quickly.

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  • 2020-bl-cmo-metrics-that-matter_132x132

    Digitization Drives Results for Contract Manufacturers

    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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  • 2020-bl-ipass-integration_132x132

    Integration Is the Fast Lane to Data

    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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  • 2020-bl-thumb-3-advantages-data-centric-quality-mindset

    3 Advantages of a Data-Centric Quality Mindset

    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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  • 2020-bl-thumb-data-integrity-and-21-cfr-part-11

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

    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-bl-thumb-life-sciences-trends-point-spotlight-data

    2020 Life Sciences Industry Trends Point Spotlight on Data

    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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  • 2020-bl-thumb-coda-corp-fda-and-data-integrity

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

    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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  • 2020-bl-thumb-pharma-trends-brief

    Top 5 Pharmaceutical Manufacturing Trends in 2020

    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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  • 2019-bl-thumb-the-surge-of-manufacturing-data-integrity-violations

    Surge of Data Integrity Violations Irritating the FDA

    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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  • 2019-bl-thumb-data-integrity-conf-takeaways-1

    Top 5 Takeaways From IVT’s Data Integrity Validation Conference

    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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  • 2019-bl-thumb-mice-habitat-impact-pharma

    Study: Effluvial Lodging for Mice Negatively Impacts Data Quality

    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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  • 2019-bl-thumb-quality-control-laboratory-data-mgt

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

    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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