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The U.S. Food and Drug Administration (FDA) recently released a draft guidance that would make it easier for medical device companies to comply with FDA regulations and the standard from the International Organization for Standardization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.
December 8, 2022
By Ave Love, Staff Writer, MasterControl
There are several things to look at to help you achieve a compliant quality management system (QMS) and consequently pass inspections. Examples include your past history with compliance, internal GMP audits, as well as the most frequent citations that show up in the U.S. Food and Drug Association’s (FDA) audit findings lists. Find out what they are and how to prepare your system for a successful audit.
December 7, 2022
By Dave Katz, Co-Founder, Intuizi, Inc.
Life sciences companies are growing more reliant on location data as the key source of data for consumer engagement. Find out how advanced technologies that focus on location data help facilitate compliance, give companies gain insights into strategic business intelligence and consumer behaviors, and give them an edge in marketing planning so they can more effectively reach consumers.
December 6, 2022
By Ave Love, Staff Writer, MasterControl
Past, present, or future, quality risk management is here to stay and continues to play an integral part of quality management systems (QMS). In the “Best Practices for Life Sciences Quality Leaders to Manage and Mitigate Risk” webinar, Peter Harris, MasterControl senior product manager, points to critical risk management failures and emergent solutions.
December 1, 2022
By Johanna Blair, Staff Writer, MasterControl
Moving away from paper and transitioning to a digital quality management system requires understanding FDA guidelines for electronic records and signatures – a key aspect of maintaining cGMP compliance. Ask these questions when considering a digital QMS solution.
November 17, 2022
By Ross Stovall, Chief Corporate Systems Architect, CloudWorks4All
An enterprise resource planning (ERP) system is a powerful tool, but it can’t take the place of a purpose-built quality management system (QMS). CloudWorks4All’s Ross Stoval explains why a dual ERP/QMS backbone is integral to success in life sciences industries.
November 16, 2022
By David Butcher, Staff Writer, MasterControl
While most manufacturers agree that digitization is essential to their success, most today can’t afford an expensive and time-consuming implementation of traditional manufacturing execution software with a slow return on investment. Implementation of a modern manufacturing execution system (MES) solution is fast and, once implemented, can deliver results quickly.
November 15, 2022
By Becky Blankenship, Technical Writer, Cannon Quality Group
Most startups in the medical device industry understand that they could streamline operations with an electronic quality management system (eQMS), but just don’t know if the benefits are worth the cost. Cannon Quality Group highlights six solutions an eQMS provides for medtech startups.
November 10, 2022
By Sarah Beale, Staff Writer, MasterControl
Dealing with remote compliance audits and inspections presented unique challenges. The new hybrid approach does have benefits, but also maintains some of the challenges from in-person and remote audits.
November 9, 2022
By Jared Evans, Lean Process Coach and Professional Instructor, MasterControl
Every manufacturer aims for continuous improvement, but one of the biggest obstacles to achieving it is getting everyone on board with new processes or solutions that will make it possible. Find out how applying a hierarchy of needs approach to a 6S program makes it makes it more likely that your teams will adopt new lean manufacturing processes or continuous improvement software.
November 8, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Masters Summit 2022 was a week of world-class education, insightful speakers, networking with industry peers, and fun. Find out which three themes repeatedly surfaced at this year’s event and what they mean for the future of medical device manufacturing.
November 3, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Change control is a critical capability for medical device manufacturers. But managing change effectively and efficiently is easier said than done. Read on to gain a deeper understanding of the core elements of change control, regulatory expectations for managing changes, and ways your organization can overcome common change-related challenges.
November 1, 2022
By David Jensen, Staff Writer, MasterControl
According to the U.S. Food and Drug Administration’s (FDA) guidance on data integrity, all data for regulated products must be complete, reliable, accurate, and consistent. Learn data management best practices to help ensure compliance with the stringent data integrity regulations.
