background image for GxP Lifeline
GxP Lifeline
  • 2020-bl-thumb-the-next-evolution-in-manufacturing

    The Next Evolution in Manufacturing

    There’s no reason to keep living in the past when it comes to your batch review process. With review by exception, you can accelerate your processes to get product out the door faster. All while reducing frustration in both quality and manufacturing.

    Full story
  • 2020-bl-quality-architech_132x132

    Is Your QMS Robust Enough to Withstand the Long Term Effects of the Recent COVID-19 Pandemic?

    A robust, flexible quality management system (QMS) is a critical part of a business. Recent issues with COVID-19 illustrate why it is important than ever to integrate the QMS with the organization’s business continuity plan.

    Full story
  • 2020-bl-gxp-lifeline-template_132x132

    Simplifying Part 11

    21 CFR Part 11 went into effect more than 20 years ago, and it remains a widely discussed regulation.

    Full story
  • 2020-bl-brandwood_132x132

    ISO 14971: 2019 and ISO TR 24971: 2019 Medical Device Risk Management Standards

    This article explores the definitive risk management standard for medical devices (ISO 14971) and the accompanying guidance on its application (ISO TR 24971) revised in December 2019. Although the basic foundation and structure of the risk management process has not changed from previous versions, revisions were undertaken to provide device manufactures with more clarity on critical aspects of risk management and hazard identification ensuring risk is effectively managed across all stages of the product lifecycle.

    Full story
  • 2020-bl-quva-case-study_132x132

    QuVa Pharma Fosters Agility and Growth by Going Paperless

    QuVa Pharma is a 503B compounding facility with a large catalog of medicines and a growing customer base. Read how the company has been improving its use of resources, efficiency and quality to keep up with increased production demands and tighter timelines.

    Full story
  • 2020-bl-carestream-logo_132x132

    Carestream Health: Modernizing Legacy Technology to Transform Manufacturing and Quality

    Legacy technology can be a significant barrier to digital transformation. At Carestream Health, process manager Eli Tuber is leading a digital transformation of the company’s operational technology, from outdated legacy systems to modern digital platforms. The company is taking a platform approach to technology modernization, including electronic device history records (eDHRs), to transform manufacturing performance and quality.

    Full story
  • 2020-bl-managing-compliance-costs_132x132

    CLIA Certification: 3 Things You Need to Know

    Testing accuracy and reliability are the top priorities of any laboratory that conducts tests on humans. To demonstrate their commitment to testing integrity, facilities in the U.S. must adhere to Clinical Laboratory Improvement Amendments (CLIA) quality regulations. The path to CLIA certification begins by addressing three fundamental questions.

    Full story
  • ukraine-mountain-landscapes-132

    Aviator Proves the Sky Is Not the Limit for Life-Changing Innovation

    Read how BraveHeart Wireless Inc. earned 510(k) approval for its Life Sensor Cardiac Monitor within one year.

    Full story
  • 2020-bl-reducing-human-error_132x132

    How to Reduce Human Error on the Pharmaceutical Manufacturing Floor

    CAPA’s will be effective when we can eliminate conditions (causes) that make people deviate from the expected outcome. Therefore, CAPA effectiveness should be measured by root cause recurrence and event recurrence.

    Full story
  • 2020-bl-using-connected-quality_132x132

    Using Connected Quality to Track Down Problems

    Mistakes are inevitable in any process. The problem is making sure those mistakes aren’t repeated and that any underlying issues are resolved. To do this, you need good systems in place for detecting problems, the severity of problems, determining a solution, and implementing that solution.

    Full story
  • 2020-bl-501k-guidance_132x132

    FDA’s New 510(k) Pathway Highlights Safety and Performance Data

    The U.S. Food and Drug Administration (FDA) continues to create avenues for life sciences companies to get products approved and on the market at a faster pace. The agency set up a new 510(k) pathway for achieving market approval, which is device-specific and based on safety and performance data. In pursuing this pathway, the agency emphasizes the importance of continuous improvement and effective data management.

    Full story
  • 2020-bl-bom_132x132

    3 Challenges that Bill of Materials Software Can Help Resolve

    A bill of materials (BOM) is crucial for ensuring a complete and accurate view of product parts and for protecting and analyzing the use of resources throughout the life cycle of a product. Any revision to a product’s design must be updated in the BOM, accurately identifying and listing what is required to produce the product. Because it extends to a variety of departments, BOM management often results in a number of common challenges for manufacturers.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 2020-bl-medtech-webinar-series-overview_132x132

    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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]