February 28, 2023
By Ross Stovall, Chief Corporate Systems Architect, CloudWorks4All
Regulatory agencies encourage companies to take a risk-based approach to validating their software systems. To help companies achieve that goal, CloudWorks4All’s Ross Stoval examines the steps involved in implementing a new, risk-based validation methodology. Read on to learn how risk-based validation practices help companies in the life sciences save time and effort while making it much easier to adopt cloud-based systems like modern electronic quality management systems.
February 23, 2023
By David Jensen, Staff Writer, MasterControl
Advanced technology has moved medical device innovation into the fast lane. It stands to reason that global regulatory agencies would step up to help keep the momentum going — and they have. In 2012, the International Medical Device Regulators Forum (IMDRF) rolled out the Medical Device Single Audit Program (MDSAP). This post details how the program works and how it continues to evolve.
February 21, 2023
By David Butcher, Staff Writer, MasterControl
If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you panic or would you go on about your day, business as usual, knowing you have a robust FDA audit process in place?
February 16, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Total Quality Management (TQM) is based on the notion that an ounce of prevention is worth a pound of cure. But employees resist deviations from the status quo, which makes the implementation of TQM principles a challenge in most pharma manufacturing settings. Find out how three sensible steps that you can take today will create a foundation for TQM success tomorrow.
February 15, 2023
By Johanna Blair, Staff Writer, MasterControl
Cell and gene therapy (CGT) manufacturing offers unique challenges regarding good manufacturing practices (GMP). Are paper batch records efficient enough to remain compliant? Learn how digital manufacturing solutions can solve some of CGTs biggest production issues.
February 14, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Professionals in the life sciences have an endless list of conferences and trade shows they can attend – but which events will give you the best reasons to attend? Find out which quality management and manufacturing conferences are the “can’t miss” events of 2023.
February 9, 2023
By Ave Love, Staff Writer, MasterControl
Some of the most prominent pharmaceutical trends relate to the supply chain disruptions and the labor market shortages that coincided with peak COVID-19 lockdown periods. As a result, individuals, businesses, and entire industries are willfully redefining themselves and the ways that they connect to one another – staying connected despite critical disruptions. Find out how an eQMS solution can help you keep pace with these trends.
February 2, 2023
By Sarah Beale, Staff Writer, MasterControl
We’ve been talking about remote audits and inspections since the COVID-19 pandemic first hit - and this trend isn’t going anywhere. What started as a necessity due to remote work quickly morphed into a process that regulatory authorities intend to continue well after the pandemic is over.
February 1, 2023
By Ryan Coughlin, Vice President, Enterey Life Sciences Consulting
Improving your business processes starts with an enhanced understanding of fundamentals. Read Enterey’s Ryan Coughlin examination of proven steps that enable companies to simplify change and quality management processes and the ways digital tools facilitate improvements.
January 31, 2023
By Johanna Blair, Staff Writer, MasterControl
Implementing truly paperless manufacturing offers quality control and production record benefits. Read about three measurable areas that are improved by switching to a connected digital manufacturing solution.
January 25, 2023
By Diane Chinn, Senior Regulatory Consultant, CGH & Associates, LTD
With the EU MDR and IVDR regulations in effect, medical device manufacturers have legitimate concerns about meeting deadlines and transitioning to new rules. Learn everything you need to know about evolving EU regulations and steps you can take to align with key requirements.
January 24, 2023
By David Butcher, Staff Writer, MasterControl
As medtech manufacturers take steps to modernize their operations through digitization in manufacturing, there are a few practical ways to put into practice the unprecedented digitization of every aspect of manufacturing.
January 19, 2023
By Ave Love, Staff Writer, MasterControl
Pharmaceutical and medical device manufacturers are increasingly looking for digital solutions to manage change control. Change control processes can be challenging to coordinate – especially in high-stakes environments. Read more to learn about change control requirements and seven characteristics of an efficient and compliant manufacturing change control system.
January 17, 2023
By Sarah Beale, Staff Writer, MasterControl
The U.S. Food and Drug Administration (FDA) recently released a draft guidance that would make it easier for medical device companies to comply with FDA regulations and the standard from the International Organization for Standardization (ISO).
January 12, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Pharma supply chains are more fragile and prone to disruption than we’d like to admit. But mitigating supply disruptions and minimizing their harmful effects requires greater flexibility and faster decision-making. Learn three steps pharma manufacturers can take to manage their supply chains more effectively.
January 10, 2023
By Ave Love, Staff Writer, MasterControl
One prominent pharmaceutical trend shows how quality is leaning into quality management maturity (QMM) and finding ways to withstand lingering disruptions and expand its reach. Find out how digital transformation is key to their success.
January 5, 2023
By David Howarth, Managing Director, iDE8 Ltd
Continuous improvement is a cost-effective way for medical device companies to ensure their quality processes remain consistent while also reducing costs and improving efficiency. Find out why continuous improvement efforts are critical to maintaining product quality in a challenging economic climate.
January 3, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Wondering which topics spark the most interest among your peers in life sciences manufacturing and quality? Check out this list of the top five GxP Lifeline articles our readers perused last year.
December 15, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Pharma manufacturers are implementing an array of production-streamlining technologies to stay competitive. But even the most advanced tools won’t help you get ahead of competitors if they’re disconnected and your production operations rely on paper-based processes. Find out how system integrations are helping manufacturers accelerate production and make their operations more efficient.
December 13, 2022
By Jaime Velez, Co-Founder, Operations & Quality Systems Improvement Experts (OQSIE)
Despite the momentum that Quality 4.0 transformation initiatives have gained in the life sciences, many such programs are at risk of failure. OQSIE’s Jaime Velez explains how document review enhancements and other quality process improvements can help quality leaders keep transformation initiatives on track.
