These seven concepts are critical to understanding the U.S. Food and Drug Administration’s guidance “Quality Systems Approach to the Pharmaceutical Current Good Manufacturing Practice Regulations.”
January 27, 2022
By Dale Thompson, Staff Writer, MasterControl
Pharmaceutical companies need to partner with contract manufacturers capable of maintaining impeccable product quality. Follow these three tips to find a CMO in the pharma industry that can meet and exceed expectations.
January 25, 2022
By Sarah Beale, Staff Writer, MasterControl
It pays to have backup plans, and the supply chain is no different. Constantly fluctuating COVID-19 protocols and transportation issues continue to plague the medical device industry, but there are steps that can be taken to deal with these problems.
January 20, 2022
By Regina Fullin, Vice President of RA/QA Consulting, Compliance Team
No pharma company wants to fail an inspection, and yet it’s common for these five mistakes to interfere with compliance efforts. Industry expert Nicole Cannon offers tips on how to avoid them along with insight into how digitization can be part of the solution. Follow her advice to get safe, effective products to market quickly.
January 18, 2022
By David Butcher, Staff Writer, MasterControl
While visibility, agility, and responsiveness have been priorities in managing supply chains for decades, the disruption and volatility around the COVID-19 pandemic amplified their critical role. In doing so, it brought to light the need to digitize and integrate supply chain systems to ensure all relevant data and insights can be connected for optimal resiliency.
To protect themselves in the face of supply chain volatility, medical device manufacturers should reassess their supply chain capabilities with an eye toward proactive, tech-enabled solutions.
January 11, 2022
By Edwin Chung, Vice President of Service Delivery, SPK and Associates
A medical device manufacturer was working across two disparate systems. The result? Mistakes made their way into the manufacturing process, which resulted in lengthy review times, and delayed speed to market. The solution was digitization, and it immediately saved them $42,000 per year.
January 6, 2022
By David Jensen, Staff Writer, MasterControl
Given the high numbers of pharmaceutical recalls and shortages, along with the current supply chain issues, product manufacturers are making modernization a higher priority. This post examines the new pharmaceutical manufacturing trends in modernization.
December 16, 2021
By Sarah Beale, Staff Writer, MasterControl
Artificial intelligence (AI) in health care has enormous potential, but AI-enabled software as a medical device (SaMD) is charting new territory. Last year, regulators indicated some of their priorities for AI in SaMD and what regulations might look like in the future.
December 14, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
FDA and other regulators are increasingly cracking down on pharma companies’ data integrity lapses. Learn the fundamentals of maximizing data usage that will help keep your quality and compliance activities aligned with regulatory expectations.
December 9, 2021
By David Butcher, Staff Writer, MasterControl
As the field of personalized medicine grows and evolves, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) take steps to address regulatory oversight in the field, affected organizations should brace themselves for change and use it to their advantage. Here are three ways that companies in personalized medicine can approach regulatory obstacles as opportunities instead.
With manufacturers digitizing at a rapid rate, understanding the core of the European Union’s (EU) guidelines, Annex 11, and its approximate FDA counterpart, 21 CFR Part 11, is more critical than ever. They are central to understanding the conditions for life sciences manufacturers’ electronic data in the EU and the U.S., and while the guidance is similar in both countries, it’s important to understand the key differences.
Inadequate quality management and poor data can be costly for a life sciences company or similarly regulated industry. However, a strong corrective action/preventive action (CAPA) program paired with a digital CAPA management tool can help differentiate your company from the competition.
December 2, 2021
By Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences, and Paul Andrea, Independent Consultant, MWA Consulting, Inc.
Whether your start up company makes pharmaceutical products, biologics, or medical devices, you all have one thing in common. You need to implement a robust digital quality management system (QMS) at the early phase of product development to comply with the ever changing and more stringent regulations throughout the product life cycle.
November 18, 2021
By Brian Curran, Senior VP of Strategic Growth, MasterControl
To support advanced data technologies and to compete in a modern market, manufacturers must close the digital gap on the shop floor, where critical production processes remain paper-based and disconnected. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.
November 17, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Validation has historically been a time-consuming, painful undertaking for medtech companies that depend on commercial off-the-shelf software solutions. As that the bulk of that burden shifts away from users and onto software providers, it’s getting easier to take a risk-based approach to validation.
November 16, 2021
By David Butcher, Staff Writer, MasterControl
With proper preparation and the right tools, a manufacturing organization can always be ready to pass a U.S. Food and Drug Administration (FDA) inspection relatively stress-free. Process mapping and gap analysis can help manufacturers not only show the FDA that a company is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.
November 11, 2021
By James Irons, Director of Strategic Development, and Samir Patel, Project Lead - Digital Systems, Sequence
The pharmaceutical manufacturing industry resists digitization and continues to rely on paper as a single source of truth for record keeping. This outdated process is inefficient and can actually create more risk in the long run. Understand the primary causes of resistance to digitization and how to address those barriers.
November 9, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Don’t settle for ambiguous quality goals when you need measurable objectives that truly affect outcomes. Learn how alignment with ISO standards can turn your wishes into real quality improvements.
November 4, 2021
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration (FDA) set up the Quality System Regulation (QSR) to give medical device companies guidelines for ensuring quality, safety, and efficacy of their devices. There are many components to the QSR, but this post focuses on the requirements that apply to records.
