July 30, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
Whether you like it or not, you should brace yourself for Industry 5.0. The term refers to people working alongside robots and smart machines. If that definition brought to mind the image of Will Smith battling evil robots in the movie “I, Robot,” here are a few things you need to know about Industry 5.0.
July 28, 2020
By David Butcher, Staff Writer, MasterControl
The pandemic has highlighted the need for a faster, more flexible and scalable manufacturing environment that balances speed with compliance. While paper-based processes can slow production down or jeopardize quality, paperless production processes can streamline operations, reduce errors and readily leverage data critical to ensuring quality. A configurable, purpose-built electronic device history record (eDHR) application can be fast to implement and deliver quantifiable benefits.
July 27, 2020
By Sarah Beale, Staff Writer, MasterControl
How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).
July 17, 2020
By Jason Orloff, Statistical & Engineering Consultant, Pharmstat
The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).
July 17, 2020
By Brandwood CKC, and Belinda Dowsett, Quality Assurance Manager and Consultant
So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.
July 15, 2020
By David Butcher, Staff Writer, MasterControl
Nelson Laboratories, a global provider of microbiological and analytical laboratory testing, is one of the many companies making an impact in the protective barriers area during the pandemic. The Salt Lake City-based company is heavily involved in testing the efficacy of facemasks and respirators. In a recent interview, Nelson Labs President Jeffrey R. Nelson spoke on what it has taken to achieve 24/7 coverage while maintaining quality and protecting employee health.
July 13, 2020
By Sue Spenser, Head of IVD and Principal Consultant, Qserve
If you are preparing to implement IVDR, there are specific gaps that are easily missed. Ensure the intended purpose is clear, risk management issues have been addressed, and pay close attention to details.
July 9, 2020
By Sarah Beale, Staff Writer, MasterControl
Cannabis is legally and socially becoming more accepted worldwide. New regulations, new products and new technology are all helping the cannabis industry mature. In 2020, these trends are expected to shape the industry.
July 7, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
As companies grow more reliant on geographically dispersed contractors, partners, vendors and business units, it gets harder to align quality across all the entities involved. Learn how global companies like Fagron maintain quality consistency across multiple sites and discover why connecting data and processes within a robust digital platform is the surest way to align quality across your entire ecosystem.
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.
