February 4, 2021
By David Jensen, Staff Writer, MasterControl
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.
February 2, 2021
By David Jensen, Staff Writer, MasterControl
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.
January 28, 2021
By Vice President, Navigator Business Solutions
Acronyms can look more like alphabet soup, but here is your cheat sheet to understand some of the most common ones used in life sciences manufacturing: LIMS, QMS, GMP and ERP.
January 28, 2021
By Cheryl Wagoner, Wagoner Consulting LLC
An integral part of remaining compliant is having and maintaining a strong global regulatory strategy. Before diving in and creating a strategy, understand what to include so it’s effective. A global regulatory strategy ultimately saves your organization time and money while making it possible to get product to market more quickly.
January 27, 2021
By Andrea Artman, Founder, SpectRA Compliance, LLC
Understand simple strategies for communicating with your review team to ensure you’re speaking a language that your regulatory authority understands, and more importantly, a language that can get your product to market.
January 21, 2021
By David Jensen, Staff Writer, MasterControl
In Sept. 2019, the U.S. Food and Drug Administration (FDA) Center for Device and Radiological Health (CDRH) introduced the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. The program was set up to foster an accredited conformity assessment arrangement between medical device manufacturers, accreditation bodies and testing laboratories. The FDA released its final guidance in Sept. 2020. This article highlights key aspects of the updated guidance.
January 20, 2021
By Andrea Artman, Founder, SpectRA Compliance, LLC
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.
January 19, 2021
By Sarah Beale, Staff Writer, MasterControl
Artificial intelligence (AI) isn’t just a cool tech trend. At the rate it’s going, it’s shaping the future of quality in the life sciences. Which is why we’ve designed a new data analytics solution that gives users complete control over their data and uses AI to drive decision-making.
January 13, 2021
By David Jensen, Staff Writer, MasterControl
At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about the future of quality management. She identified some key strategies for how your organization can identify and understand quality assurance trends and develop initiatives for long-term success.
January 12, 2021
By David Jensen, Staff Writer, MasterControl
At MasterControl’s Virtual Masters Summit 2020, vice president of engineering Alan Rencher provided valuable insight about force multiplication and how it gives companies the ability to seamlessly integrate business units, excel in all aspects of operations and sustain a competitive advantage.
January 7, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
In the wake of a global pandemic, supply chain disruptions that were once inconveniences have become existential threats to many life sciences companies. Learn the steps your organization can take to build a more resilient supplier ecosystem.
January 5, 2021
By David Butcher, Staff Writer, MasterControl
Every organization is dealing with a deluge of data and the challenges of uncertainty. Companies are drowning in data but starving for insights in a time of rapid change, both domestically and globally. What’s needed is the ability to easily access, analyze and apply data in real-time to current challenges, while using the information to better plan for and shape the future. At Virtual Masters Summit 2020, two thought leaders highlighted ways that emerging technology and data can help life sciences organizations move forward during uncertain times.
January 4, 2021
By Regina Fullin, Vice President of RA/QA Consulting, Compliance Team
With 2020 behind us, let’s take stock of what happened during the year and how the face of regulated medical industry has changed. Heading into 2021, be ready for remote options, deferred enforcement of regulations and more.
December 30, 2020
By Peter Knauer, Managing Partner and Co-Founder, Sage BioPartners
Updated guidances for process validation suggest using a risk-based life cycle management approach with relevant scientific rationale and evidence in lieu of a traditional top-down comprehensive approach. This article presents an approach to risk management for successfully meeting the regulatory guidelines for validation.
December 22, 2020
By Director of Marketing, MasterControl
It’s impossible to avoid occasional nonconforming products and materials. But what’s most important for manufacturers of regulated products is how nonconformances are managed. Learn how to handle nonconformance challenges, avoid warning letters and maintain alignment with FDA and ISO requirements.
December 21, 2020
By David Jensen, Staff Writer, MasterControl
Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.
December 17, 2020
By Dale Thompson, Staff Writer, MasterControl
Integrate disparate systems and get the most out of your investment in technology designed to streamline manufacturing operations. This will make it possible to improve efficiency, eliminate mistakes and scale quickly.
December 16, 2020
By Kathleen McHugh, Systems Lead Engineer, MPR Associates, Inc.
With the update to internationally recognized standard ISO 14971: Medical devices — Application of risk management to medical devices late in 2019, many manufacturers have taken a hard look at strengthening their post-production procedures over the past year to make improvements to how risk is managed throughout the entire product lifecycle.
December 15, 2020
By Quality Team Member, Cannon Quality Group
Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.
December 14, 2020
By Dale Thompson, Staff Writer, MasterControl
Every day, we use technology to make our lives easier. Similar technology is available to streamline manufacturing processes. It’s time to digitize and make production errorless, visible and connected.
