GxP Lifeline

 

  • Quality Control, Quality Assurance and the EQMS That Improves Both

    6 February, 2020 by Sarah Beale, Staff Writer, MasterControl

    Quality is an important part of doing business in regulatory environments. However, the differences between quality assurance and quality control can be hard to pin down. Learn how both play into quality management and how an enterprise quality management system simplifies them.

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  • Why Quality 4.0 Should Be a Top Priority for Quality Managers

    4 February, 2020 by Mike Rigert, Staff Writer, MasterControl

    As a new calendar year approaches, the technology at our disposal is exceeded only by the number of ways it can be applied to improve communication, understanding, planning and productivity. In fact, the last decade has seen such rapid advances in areas like connectivity, mobility, analytics, scalability and data that it has sparked a fourth industrial revolution, known as Industry 4.0. IT and operations teams are chomping at the bit to implement these new technologies to help them operate better, smarter and faster. But what does this mean for quality and the teams responsible for it?

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  • Quality’s Unstructured Data Dilemma: 3 Reasons to Overcome Document Dependency

    30 January, 2020 by James Jardine, Staff Writer, MasterControl

    Companies whose quality management practices are document dependent are neglecting the insights trapped in their quality data. Learn about the promise and peril of unstructured data and how connectivity can unlock your quality function’s potential.

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  • Disruptive Outsourcing Means Life Sciences Are Relying on CMOs More Than Ever

    28 January, 2020 by Mike Rigert, Staff Writer, MasterControl

    Life sciences manufacturers’ reliance on outsourcing is on an upward trajectory. However, recent disruptions to how and why companies turn to contract manufacturing organizations (CMOs) and related contract services are changing the playing field. To maintain quality and control of products in this more dynamic outsourcing ecosystem, companies should seek greater collaboration.

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  • The Importance of Intended Purpose and State of the Art in Implementing EU’s IVDR

    23 January, 2020 by Sue Spencer, Head of IVD and Principal Consultant, QServe

    The European Union’s In Vitro Device Regulation (IVDR) is replacing the In Vitro Device Directive (IVDD) on May 20, 2022, and there’s not a moment to spare in preparing for the new regulation. An in vitro diagnostic (IVD) expert with QServe lays out the most important requirements of IVDR that IVD manufacturers will need to begin planning for to recertify their devices.

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  • Augmented Intelligence Helps Clarify Human/AI Roles in the Workplace

    21 January, 2020 by David Jensen, Staff Writer, MasterControl

    For decades, the science fiction world has often included some version of artificial intelligence (AI). While audiences were watching AI entities and robots come alive on the big screen, technology scientists were busily researching and developing the real thing. This article discusses the concept of augmented intelligence and how it underscores the importance of human creativity and innovation in the context of advanced technology and artificial intelligence.

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  • Christmas Comes Early to Medtech: U.S. Repeals Device Excise Tax

    16 January, 2020 by Mike Rigert, Staff Writer, MasterControl

    With the release of the ninth and final Star Wars film in the so-called Skywalker saga, December 2019 was a big month for fans. It was even a bigger month in the medtech galaxy, where the U.S. Congress’ permanent repeal of the 2.3% device excise tax extends a prime opportunity to device makers to reinvest the savings in cost-competitive measures.

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  • 3 New Year’s Resolutions for Your Company

    14 January, 2020 by Sarah Beale, Staff Writer, MasterControl

    The new year is the typical time when we set resolutions to improve ourselves. Since companies are in need of improvement too, make a resolution to digitize your business. If you’re not sure how to start, we’ve got some ideas.

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  • 7 Critical FDA Concepts for Pharmaceuticals Quality Systems

    14 January, 2020 MasterControl

    From the discovery of penicillin in the late 1920s to the breakthrough anti-cholesterol and anti-HIV drugs being manufactured today, the pharmaceutical industry has always been in the front line of developing new technologies. But the industry has yet to fully embrace modern quality systems operations.

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  • 7 Steps to Ensure CAPA Success

    9 January, 2020 by Mike Rigert, Staff Writer, MasterControl

    Inadequate quality management and poor data can be costly for a life sciences company or similarly regulated industry. However, a strong corrective action preventative action (CAPA) program paired with a digital CAPA management tool can help differentiate your company from the competition.

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  • To Pre-Sub or Not to Pre-Sub? Weighing the Value of the FDA’s Pre-Submission Program

    7 January, 2020 by J. Lawrence Stevens, RAC and principal consultant, One Way Consultants

    The U.S. Food and Drug Administration’s Pre-Submission program was created to with the intent of lowering medical device companies’ submission times. Gain some valuable insights about how the program can help you get clearance for your device and increase speed to market.

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  • 3 Keys to Implement an Integrated Management System With ISO 9001

    31 December, 2019 by Christine Park, Founder and Owner, Christine Park and Associates

    Life sciences companies that implement an integrated management system (IMS) can provide both improved compliance with ISO 9001:2015 while also better aligning your organization’s quality system and business model. Learn how to harmonize your systems.

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  • The Standards Harmonization Process and 5 Tips to Manage It With EU MDR

    24 December, 2019 by Dr. Arthur Brandwood, Director and Principal Consultant, Brandwood CKC

    There’s been considerable disquiet over the lack of available harmonized standards to support the European Union’s Medical Device Regulation (MDR). Learn about European harmonization standards processes and how medical device manufacturers can best manage the current state of regulatory uncertainty.

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  • Purpose-Built Manufacturing Systems: Once a Virtue, Now a Vice

    19 December, 2019 by Beth Pedersen, Staff Writer, MasterControl

    As technology and the marketplace undergo drastic change, it seems the ROI of enterprise manufacturing software systems has reached a tipping point. But with the help of new additive technologies and small automation efforts, core systems will continue to play a significant – albeit evolving – role in modern manufacturing.

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  • Santa’s Little Auditor

    17 December, 2019 by Sarah Beale, Staff Writer, MasterControl

    It’s the time of year for parents to pull out the Elf on the Shelf and regale their children with stories of how their behavior gets reported back to Santa. Making sure those reports are accurate depends on whether the elf is using paper or digital solutions.

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  • Surge of Data Integrity Violations Irritating the FDA

    12 December, 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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  • The FDA Mulls Proposed Ratings to Measure Drugmakers’ Manufacturing Quality

    11 December, 2019 by Mike Rigert, Staff Writer, MasterControl

    A recent U.S. Food and Drug Administration (FDA) report indicates one of the reasons for drug shortages in the U.S. is the absence of incentives for manufacturers’ facilities to go beyond minimal quality compliance. A proposed voluntary FDA ratings system based on objective criteria could potentially benefit and reward drugmakers for their facilities’ heightened quality manufacturing maturity.

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  • Innovation and Compliance Harmonize Perfectly at Cochlear

    10 December, 2019 by James Jardine, Staff Writer, MasterControl

    Cochlear’s cochlear implants are more than just groundbreaking medical devices — they’re a life-redefining means through which people with hearing loss to connect with the world. Learn how the company is bringing innovative products to more people in need by accelerating quality and compliance processes with robust digital solutions.

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  • Digital Supply Networks and Smart Factories: The Future of Manufacturing

    5 December, 2019 by Mike Rigert, Staff Writer, MasterControl

    The further we go into the 21st century the more it becomes apparent that the future of manufacturing will be digital. Find out how digital supply networks and smart factories will form the backbone of the digital transformation and what role quality and an automated quality management system (QMS) will play as manufacturing enters the Fourth Industrial Revolution.

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  • 5 Ways to Prepare for the Future of Quality Now

    4 December, 2019 by Sarah Beale, Staff Writer, MasterControl

    The future of quality is closer than you might think, and the time to prepare is now. During the 2019 Masters Summit, MasterControl Partner KPMG presented a session on the future of quality and how it can help the life sciences industries now.

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