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GxP Lifeline
  • MasterControl Logo

    Happy Manufacturing Day!

    To celebrate Manufacturing Day, we’re encouraging future manufacturers to look at some of the exciting trends happening in the industry. This includes organizations coming together to address COVID-19 and stepping into the world of artificial intelligence.

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    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-gcp-compliance-hack_132x132

    GCP Compliance Hack: How to Avoid the Most Common Warning Letter Trigger

    The most frequently cited good clinical practice (GCP) violation is a failure to adhere to a study’s investigational plan. But there’s a straightforward solution to your protocol compliance woes. Hint: it doesn’t involve the disconnected, mostly paper-based systems currently used to manage clinical trials.

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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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    Navigating Life Sciences Manufacturing During a Pandemic

    Life sciences manufacturing during COVID-19 has changed dramatically. That’s why we’ve worked with MedTech Association and MASSMedic to bring you a 10-part webinar series about how to scale and pivot during the pandemic.

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  • 2020-bl-cannabis-supply-chain_132x132

    Compliance Data: A New Solution for Maintaining Cannabis Supply Continuity

    Cannabis supply chains need to deliver high-quality products with consistency and foresight. Using state compliance data, it’s possible to ensure supply networks and regulators have all the necessary information they need for greater visibility and collaboration.

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  • 2020-bl-covid-19-the-cloud_132x132

    Why COVID-19 Is Driving Companies Toward the Cloud

    As the COVID-19 pandemic escalated, urgency and adaptability became the theme for organizations as they were suddenly tasked with enabling their entire workforce to work remotely. This scenario has largely been the impetus for more companies accelerating their migration to the cloud.

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  • 2019-bl-thumb-purpose-bulit-manufacturing-systems

    Understanding GxP Predicate Rules Is Key to Compliance With FDA 21 CFR Part 11

    FDA 21 CFR Part 11 does not invalidate the predicate rules that were established for paper-based document management systems, it simply builds upon and reinforces those existing rules in digital platforms. Learn about the symbiotic nature of Part 11 and FDA predicate rules and discover how an awareness of their relationship is fundamental to easing compliance burdens.

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  • 2020-bl-change-pharma-mfg_thumb

    Deviation and Change Control in Pharmaceutical Manufacturing

    In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.

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  • 2020-bl-cloud-ultimate-guide2_132x132

    Cloud-based QMS Launches in Australia

    MasterControl’s cloud-based quality management system (QMS) is now available in Australia. An increasing number of businesses are modernising their operations and discovering the advantages of cloud computing. Explore the ways cloud technology makes it possible to enhance your competitive edge.

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  • 2020-bl-coda-corp-vaccines_132x132

    The Fundamentals of Immunization, Part 2

    The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. This is the second of a three-part series on the fundamentals of immunization.

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    The Challenges of Cloud Compliance in a Regulated Environment

    Life sciences companies are migrating the cloud. To be successful with cloud compliance in a regulated environment, it’s important to understand the key challenges and know how to address them. While cloud host providers offer security features, it is your organization’s responsibility to confirm the provider is compliant.

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    How to Approach Design Control From Both FDA and ISO Viewpoints

    Design control plays a key role in producing a successful medical device or IVD tool in initial development and through its lifecycle. Learn some tips on how to approach a design control strategy from either FDA or ISO perspectives.

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  • 2020-bl-coda-corp-vaccines_132x132

    "The Fundamentals of Immunization, Part 1"

    The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. Inoculation,vaccination and immunization are terms that are often used interchangeably, but have very different meanings.

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  • 2020-bl-quality-architech_132x132

    New Ultimate Guide Presents In-Depth Look at Cloud Technology

    Discoveries and new opportunities are expanding across the industrial spectrum. At the same time, more businesses are modernizing their operations to benefit from scientific and technology innovation. The core of all this progress and growth is the cloud.

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    Top 5 Manufacturing Shop Floor Safety Tips

    Optimizing shop floor safety practices is as straightforward as abiding by five fundamental manufacturing safety tips. Learn how the right ideology can enable a manufacturer to establish effective shop floor safety practices and extend a safety-centered mindset across the entire enterprise.

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  • Top 4 Reasons Why Documentation Reviews Are Critical to Compliance

    When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

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  • 2020-bl-asia-launch-announcement_132x132

    Unparalleled Paperless Manufacturing Solution Now Available Globally

    A game-changing software solution that allows manufacturers to digitally connect and gain control of their data and documentation is now available globally and in 10 different languges. Learn how companies around the world are bridging the gap between operational excellence and smart manufacturing.

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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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