July 7, 2022
By James Jardine, Staff Writer, MasterControl
Thanks to 21 CFR Part 11, the FDA recognizes that digitized records and signatures are just as valid as those maintained on paper. But that doesn’t mean Part 11 supersedes the requirements previously established in FDA predicate rules. Find out why your company’s compliance is dependent on understanding the applicable predicate rules.
June 30, 2022
By Johanna Blair, Staff Writer, MasterControl
Receiving an FDA 483 or warning letter requires prompt action from medical device manufacturers. But writing a response letter with remediation plan can seem daunting. These 10 things can start savvy manufacturers off on the right path.
June 28, 2022
By David Butcher, Staff Writer, MasterControl
Even as digital transformation efforts accelerate in various areas of manufacturing, there remains an offline data gap created by device history records (DHRs) that rely on paper, spreadsheets, and other standalone systems. This gap slows production, quality review, and product release. What is missing in medtech manufacturing operations is the electronic DHR (eDHR) solution.
June 22, 2022
By Ave Anderegg, Staff Writer, MasterControl
Audits provide crucial information to both FDA regulators and the medical device firms being audited. Depending on how proactive, consistent, and collaborative audit strategies are within medical device firms, investigations can become an asset to accelerate the development of safer, higher-quality products. Learn how using a medical device audit management software system can help your organization overcome common challenges while also providing benefits such as shorter audit times and less frequent visits from investigators.
June 21, 2022
By Ave Anderegg, 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.
June 15, 2022
By Sarah Beale, Staff Writer, MasterControl
Year over year, the biggest issue for pharma companies remains the same. Data from the U.S. Food and Drug Administration (FDA) shows that warning letters and Form 483s are most commonly issued for the same reason.
June 14, 2022
By Jaime Velez, Co-Founder, Operations & Quality Systems Improvement Experts (OQSIE)
Life sciences companies can leverage their current processes to start extracting meaningful data from their quality management systems, but many are missing the opportunity. OQSIE’s Jaime Velez explains how improvements to document review processes can make this happen, and how it is feasible in the near term for companies to make better data-driven decisions and improve the overall quality of their products.
June 9, 2022
By James Jardine, Staff Writer, MasterControl
Compliance with ISO 13485 requirements is evidence that a medtech manufacturer’s quality management system (QMS) and devices measure up to the highest standard of quality recognized worldwide. Just because the standard is widely acknowledged, however, doesn’t mean it’s well understood. Find answers to the most frequently asked questions about the medical device industry’s definitive QMS standard.
June 8, 2022
By Nancie E. Celini, DrPH, Organizational Change Management Leader, Think-OCM.org
The implementation of an electronic quality management system (eQMS) includes multiple, sometimes complicated stages. A sound organizational change management (OCM) is key to ensuring purposes and roles are clearly understood and that leaders are in lockstep strategically and operationally. The third part of this series on OCM implementation strategies explains how to create a blueprint for successful outcomes and prepare the way for your next project success.
June 2, 2022
By Sarah Beale, Staff Writer, MasterControl
Supplier audits are the cleverly disguised exams of the manufacturing world. Suppliers and manufacturers are held to high quality standards and both must adhere to them to ensure final products are safe and effective. The key to this is a thorough supplier audit in which the supplier and manufacturer work together to improve quality throughout the supply chain.
May 31, 2022
By David Jensen, Staff Writer, MasterControl
The future of pharma manufacturing is here, and companies are racing to stay up to speed with the latest industry trends. A new interactive infographic tests your knowledge of pharma manufacturing trends and illustrates the optimal pharma manufacturing operation.
May 26, 2022
By Jason Jegge, Quality and Regulatory Consultant, MWA Consulting, Inc.
There are more similarities than differences in the ways medical devices are regulated in the U.S. versus their regulation in Europe. But those subtle differences are critical to understand if you plan to market devices in both regions. See how EU and U.S. medical device regulations compare and learn how digitization streamlines compliance in both regions.
May 25, 2022
By Ave Anderegg, Staff Writer, MasterControl
A manufacturing execution system (MES) solution should offer you the best pharma MES functionality in a simplified package to match your current and future manufacturing needs. Beyond that, it should also expand your visibility across critical pivot points throughout your manufacturing operation. Ultimately, it should support your organizational growth. This post discusses how a modern MES achieves these things.
May 24, 2022
By James Jardine, Staff Writer, MasterControl
As we cope with the aftermath of COVID-19 in these uncertain times, it’s critical for pharma outsourcers to control the controllable aspects of supply continuity. These three practical steps will prepare pharma CMOs and CDMOs to handle the supply continuity challenges that will inevitably arise.
May 19, 2022
By David Butcher, Staff Writer, MasterControl
For most production environments, the barriers to adopting a traditional manufacturing execution system (MES) have kept many organizations from digitizing and automating their manufacturing environment. However, new manufacturing technologies are providing smarter, faster, and more affordable paperless shop floor alternatives to legacy MES solutions.
May 18, 2022
By Sarah Beale, Staff Writer, MasterControl
For years now, the FDA has observed that ISO 13485 and 21 CFR Part 820 have a great deal in common and largely accomplish the same level of quality assurance. Now the FDA’s working on harmonizing them.
May 17, 2022
By James Jardine, Staff Writer, MasterControl
Intelligent, connected technologies are transforming the way life sciences companies manufacture and ensure the quality of their products. To stay competitive, companies are taking advantage of advanced tools and new technology-enhanced approaches to quality management. Leveraging the new solutions and enhanced levels of connectivity now available requires that you first understand three foundational principles of fruitful Quality 4.0 initiatives.
May 11, 2022
By Ave Anderegg, Staff Writer, MasterControl
Compliant medical device design is governed by federal regulations along with competitive market needs. The essential aspects of a design control subsystem are outlined here, along with the most strenuous tasks related to design control, including design reviews. Converting from paper or hybrid quality management systems to an automated one can further reduce the challenges related to managing the Design History File (DHF) and help you to be ready for FDA inspections at any time.
May 5, 2022
By Nancie E. Celini, DrPH, Organizational Change Management Leader, Think-OCM.org
The digitalization of quality processes can bring transformative change to an organization, but doing it right requires a sound strategy. Learn the four steps that form the foundation of a good organizational change management (OCM) plan.
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