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 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.
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.
October 25, 2022
By Sarah Beale, Staff Writer, MasterControl
After several years of delay, the U.S. Food and Drug Administration (FDA) issued its computer software assurance (CSA) guidance. Now that it’s out, here are some things from the guidance to keep in mind the next time a validation project comes up.
October 18, 2022
By David Butcher, Staff Writer, MasterControl
Rigid, hard-coded process configurations often make traditional manufacturing execution systems (MES) difficult to adapt and scale. The no-code configuration provided by modern MES solutions allows manufacturers to configure quickly and allows for the flexibility to adjust processes, material, and equipment changes for varying products.
October 13, 2022
By Ave Love, Staff Writer, MasterControl
Regularly auditing your quality management system is vital to maintain performance as well as compliance. Internal audits are an integral part of fulfilling global standard requirements, including those set forth by regulatory bodies like ISO, FDA, and ICH. Discover five tips that you can use for any type of audit you need to perform. Look here for the tools that can help you overcome the challenges of auditing and turn your findings into fixes.
October 11, 2022
By Johanna Blair, Staff Writer, MasterControl
Quality events are inevitable, so it’s smart to use a CAPA management system. But, what constitutes a CAPA in the first place? Collecting nonconformance data with the right CAPA metrics can help you manage CAPAs more accurately and effectively — while avoiding future risk.
October 6, 2022
By Michelle Tanner, CFO, MasterControl
If you plan to delay technology investments to soften the recession’s blow, MasterControl CFO Michelle Tanner has news for you. Read on to get four recession survival tips and learn why those who don’t embrace advanced digital tools will lose ground in a down market.
October 4, 2022
By Kevin Ballard, Senior Project Manager, Validation on Demand, MasterControl
The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.
September 29, 2022
By Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences, and Myrna Russell, Director of Quality and Audit Management, MWA Consulting, Inc.
To ensure you’re able to manufacture high-quality products and safeguard patient safety and data integrity, your organization must be able to effectively manage supplier quality. Find out how taking a risk-based approach and applying modern tools can improve your supplier management capabilities.
September 28, 2022
By Brian Freymann, Director of Health Life Science & Strategic Accounts, Microexcel, Inc.
Criminal opportunists are making a killing off counterfeit versions of life sciences manufacturers’ products. Learn why serialization is the key to getting fake products off the market and ensuring consumer safety.
September 27, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Streamlined production and quality processes are the keys to meeting the rising demand for cell and gene therapy manufacturing expertise and capacity. Find out how digitally bridging the gap between production and quality is helping companies thrive in the CGT space.
