June 30, 2020
By Susan Schniepp, Distiguished Fellow at Regulatory Compliance Associates, Inc
Data integrity is a high priority to both the pharmaceutical industry and regulatory authorities. To improve data integrity, it's critical to example the role of quality in your company culture.
June 26, 2020
By David Jensen, Staff Writer, MasterControl
Regulated companies are often reminded that if it isn’t documented, it didn’t happen. It’s also safe to say if it is documented, but the documents can’t be found, it didn’t happen. An efficient document control system is at the core of quality management and good manufacturing practices.
June 23, 2020
By Lynessa Erler, Director of Product Testing at MPR Associates, Inc.
Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.
June 18, 2020
By Dale Thompson, Staff Writer, MasterControl
Rising demand for contract manufacturing organizations (CMO) necessitates growth to new locations throughout the U.S. and across the globe. The result of this expansion is increased production, but also a more complex supply chain, which requires digital collaboration with brand owners.
June 16, 2020
By Rai Chowdhary, CEO of KPI System (Key Performance Improvement)
The time for manufacturers to prepare for a post-COVID-19 world is now. Re-calibrate for the ""new normal"" by looking to these ""three c's"" for guidance.
May 28, 2020
By Mukul Dakwale, Principal Consultant, Luceats Consulting
An array of advanced technology and digitization are rapidly changing the landscape of pharmaceutical manufacturers and their supply chains. Mukul Dakwale, principal consultant at Luceats, explains how formulating a digitization strategy and implementation plan can help your pharma company transition from disparate, manual data systems toward end-to-end automation.
May 27, 2020
By Jim Leonard, Senior Consultant, QSG
The philosophy and cultural of minimalism and “settling” can be disadvantageous when it comes to quality manufacturing standards and expectations. Jim Leonard, a senior consultant with QSG, presents quantitative and qualitative analysis of how such approaches can stagnate quality and shares tips on how to achieve a high level of continuous improvement in manufacturing.
May 26, 2020
By Gert W. Bos, PhD, Fraps, Executive Director and Partner, the QServe Group
The much-anticipated one-year delay of the European Union’s Medical Device Regulation (MDR) finally dropped earlier this month. Gert Bos, Executive Director and Partner of the Qserve Group, breaks down what this means for device manufacturers and for their preparations to recertify under the new regulation through a designated Notified Body.
In response to COVID-19, our customers and so many others are working hard on the front lines, behind the scenes, and everywhere in between. From everyone at MasterControl: Thank you!
May 19, 2020
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
The rapid global spread of the coronavirus caught many world governments and health authorities off guard. Gina Guido-Redden, co-founder and COO of Coda Corp USA, offers a comprehensive review of the how the U.S. Food and Drug Administration (FDA) has responded thus far to the pandemic under 21 CFR.
May 14, 2020
By Matt Brawner, Director of Sales Execution, Sequence, and David Jensen, Staff Writer, MasterControl
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.
May 14, 2020
By Brandy Chittester, President, IMARC Research
Successful clinical trials are a critical stage in the product life cycle of any life sciences product. Brandy Chittester, president of IMARC Research, outlines how manufacturers can conduct well-controlled trials that meet regulatory compliance and delineates pharmaceutical trials from those of the medical device industry.
May 12, 2020
By Mike Rigert, Staff Writer, MasterControl
Technology and digital transformation are rapidly altering the way medical device manufacturers accelerate production and innovate new products. A new e-book “Mastering Data to Drive Medical Device Innovation to 2030” looks at how the medtech ecosystem is moving toward a more data-centric approach to quality manufacturing. Automated solutions integrated into a digital platform offer device makers the tools to generate real-time intelligence and insights that will lead to greater innovation over the next decade.
May 5, 2020
By David Jensen, Staff Writer, MasterControl
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.
April 30, 2020
By Luis Jimenez, Vice President of Business Development, Brandwood CKC
The U.S. Food and Drug Administration's (FDA) 510(k) pathway for medical devices is aimed at simplifying and instilling more predictability in the regulatory process. This article examines 2019 data on manufacturers’ use of the regulatory pathway and looks at some trends and takeaways for device makers.
April 28, 2020
By Dale Thompson, Staff Writer, MasterControl
Your path to quality manufacturing is simple: eliminate paper production records and digitize your shop floor. Follow these steps to achieve results that matter and drive revenue.
April 21, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
Shrinking margins, intensifying competition and rapidly increasing product personalization and customization are complicating new product introduction pipelines in the life sciences. Leveraging the data connectivity capabilities of platforms is the key to overcoming these and other obstructions to a connected quality life cycle.
April 9, 2020
By Angelo Scangas, President and CEO, Quality Support Group (QSG)
A manufacturer’s ability to maintain high-quality products and regulatory compliance depends largely on its suppliers’ own quality-related activities. Leveraged correctly, supplier audits can be an important tool that gives manufacturers greater visibility into these activities, according to Quality Support Group CEO Angelo Scangas.
April 7, 2020
By David Jensen, Staff Writer, MasterControl
The International Organization of Standards (ISO) is a global organization that defines essential requirements for helping businesses improve their products, services and customer relations. Applying these guidelines enables organizations to give their customers the assurance that their products and services are safe, reliable and of good quality. This article introduces the most popular ISO standards and discusses how companies can use them to gain a competitive edge in their markets.
April 2, 2020
By Sarah Beale, Staff Writer, MasterControl
At this point, COVID-19 has touched everyone’s life in some way. While we’re still struggling to keep up with the pandemic, many of our customers are undergoing initiatives to test and/or treat the virus.
