September 20, 2023
By Rahul Kallampunathil, VP Digital Risk, Privacy, and Compliance, Arbour Group LLC
There are many views about what the FDA’s recent draft guidance on computer software assurance (CSA) means and how compliance with it differs from traditional approaches to computer software validation (CSV). Arbour Group’s Rahul Kallampunathil offers an in-depth look into what CSA entails and the benefits it provides.
September 19, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Nothing is propelling efficiency in manufacturing like modern digital tools. This blog post examines the impact of digital work instructions in manufacturing, the increasingly important role of manufacturing work instruction software, and how these modern solutions fit into the broader manufacturing execution system (MES).
September 13, 2023
By Greg Waldstreicher, Chief Executive Officer, Botable
Artificial intelligence is revolutionizing the management of quality documentation. Botable CEO Greg Waldstreicher examines how AI is reshaping quality documentation search and explores the AI-driven future of quality management.
September 7, 2023
By Ave Love, Staff Writer, MasterControl
A modern approach to quality event management requires modern tools. Find out how advanced process capabilities align with the tenets of Quality 4.0. Quality professionals can finally leverage their expertise and guide organizations into a state of continuous improvement with a customizable CAPA management solution.
August 31, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Purchasing quality management system (QMS) software is just the first step to improving product quality and streamlining processes. Implementation takes just as much thoughtful preparation and planning. Learn the secrets to aligning people and resources and ensuring a smooth QMS implementation.
August 22, 2023
By Kevin Ballard, Senior Project Manager, Validation on Demand, MasterControl
Computer software validation doesn’t have to take months. The patented Validation Excellence Tool (VxT) cuts validation time to an average of 45 minutes for an upgrade. Now, MasterControl is taking things a step further by cutting the time down to an average of just 10-20 minutes.
August 16, 2023
By Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences
Regulators expect your CAPAs to tell a complete story of how you’ve identified and fixed problems. MWA’s Lisa Helmonds examines exactly what regulators are looking for in modern CAPA systems, why CAPAs are critical, and how they can benefit businesses.
August 15, 2023
By David Jensen, Staff Writer, MasterControl
We have entered an era of connectivity, advanced analytics, and automation in manufacturing. The future of manufacturing is here, and life sciences companies are scrambling to keep up. This post addresses the obstacles manufacturers are overcoming to digitize their operations.
Most life sciences manufacturers will tell you they highly prioritize continuous improvement, but the inevitability of constant change makes it challenging to tackle. And it’s even harder to navigate without a roadmap. Enterey Life Sciences’ John Chiechi examines principles that can help companies continuously improve manufacturing processes in a faster, less burdensome, and more balanced way.
August 8, 2023
by Sanjiv S. Gupta, CEO/Co-Founder, Irepa International
Technology integrations are valuable for creating efficiencies, but their technical aspects can be daunting. Using hydrogen production as an example, Irepa’s Sanjiv S. Gupta examines effective models for building a successful manufacturing integration framework.
August 3, 2023
By Sarah Beale, Staff Writer, MasterControl
Quality management failures are a headache in any industry, but the consequences are potentially fatal in the life sciences where life-saving products are on the line. One way to significantly reduce the odds of failure in your organization is to use an electronic quality management system (eQMS).
August 2, 2023
By Shantharam Gummaraju, Founder and CEO, ClinBiometrics, Inc.
Life sciences companies are improving the efficiency, effectiveness, and transparency of their quality management processes by embracing digital technologies. Read on to discover how innovative digital tools can streamline quality management in your organization.
July 27, 2023
By David Butcher, Staff Writer, MasterControl
Despite the investments that manufacturers have made in core digitization and automation, many producers stop short of digitizing their production records and other shop floor data collection efforts. The shop floor is a critical, but often overlooked, opportunity to make quality proactive rather than reactive. Every operator, step and output of the production process is a chance to establish quality and compliance – but only if operators have the tools to deliver quality at the source.
July 27, 2023
By Johanna Blair, Staff Writer, MasterControl
Document management systems have come a long way since the days of paper and filing cabinets. Learn how things have changed and how you can benefit from modernizing your document management system.
July 26, 2023
By Dan Sweeney, Director, Sware Partnerships & Strategic Alliances
Traditional document-centric computer system validation is now two digital transformations behind leading-edge technology, as the industry still struggles to leverage the cloud and AI for validation. Sware’s Dan Sweeney examines how outdated processes are holding companies back from moving to Validation 4.0 and how process-centric validation can move them into the fast lane.
July 25, 2023
By David Jensen, Staff Writer, MasterControl
Additive manufacturing (AM), often referred to as 3D printing, is a useful technology that’s frequently used for product research and development in many industries. The medical device industry is seeing more additive manufacturing being used in commercial product development, offering significant value in the production of customized, fast-to-market devices.
July 25, 2023
By David Butcher, Staff Writer, MasterControl
Medtech manufacturing organizations face constant challenges around disruptive technologies, fast-growing amounts of data, and a changing regulatory landscape. As the use of advanced technology such as artificial intelligence (AI) and machine learning (ML) in medical devices in increases, so will new rules and regulations. To better navigate changing compliance requirements, manufacturers in the field of medical technology must leverage digitization in manufacturing to build quality assurance into production and improve data management across the product life cycle.
July 25, 2023
By David Butcher, Staff Writer, MasterControl
The global COVID-19 pandemic has forced many manufacturers to re-examine how they manage their supply chains. Amid large-scale shocks to supply and demand, manufacturers and their supplier partners must balance speed with quality, without putting their own employees at risk or adding significant costs. Now is the time to. Leveraging digital supplier management tools can help manufacturers streamline supplier processes like audits and inspections without the on-site threat to employees and vendors and unnecessary travel costs.
July 20, 2023
By Sarah Beale, Staff Writer, MasterControl
Like many great ideas, lean manufacturing is a seemingly simple idea that proves very difficult to implement. Its shortest definition is doing something in the most efficient, least wasteful way. Sounds simple, but when you get into the details, things can get complicated. That’s where data comes in.
July 20, 2023
By Ave Love, Staff Writer, MasterControl
Depending on the degree of paper processes still being used by CMOs and CDMOs, their range of motion, or flexibility, to change with current market demands will be limited. We can look to an ancient paper application that has begun to utilize technology and discover the scope of transformation that becomes possible in life sciences manufacturing by eliminating every sheet of paper.
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