August 16, 2022
By Ave Love, Staff Writer, MasterControl
End-of-line quality control comes too late in a competitive market. Regulators have long emphasized the systematic integration of quality within manufacturing processes to yield safer and more efficient pharmaceuticals. Get clarity on the role of Quality by Design (QbD) in modern pharma manufacturing and learn why a purpose-built quality management system is the most effective means of implementing it.
August 11, 2022
By Johanna Blair, Staff Writer, MasterControl
Standard operating procedures (SOPs) are integral to successful quality management. However, they are not always the easiest to write or update. Learn how to improve compliance by building better procedural documents.
August 9, 2022
By Jaime Velez, Co-Founder, Operations & Quality Systems Improvement Experts (OQSIE)
Lack of visibility into quality operations can keep you from gleaning actionable information from data that’s already at your disposal. OQSIE’s Jaime Velez explains how document review templates can help your organization significantly improve performance and the quality of your products.
August 4, 2022
By David Jensen, Staff Writer, MasterControl
When a medical device fails to function as intended, it can potentially affect patient safety and brand reputation and even lead to a recall. With effective root cause analysis, organizations can more easily detect, resolve, and prevent problems.
August 4, 2022
By David Jensen, Staff Writer, MasterControl
There are numerous U.S. Food and Drug Administration (FDA) regulations surrounding data integrity. A good approach to maintaining data integrity compliance is to develop a practical data integrity plan for successful data management.
July 21, 2022
By Samantha Black, PhD, Head of Content, Elemental Machines, and Pratik Patel, Product Marketing Director, Elemental Machines
It’s impossible to compete in the high-pressure biotech world if your tools and internal processes aren’t up to the task. Learn how pairing advanced, purpose-built technologies can help streamline laboratory operations (LabOps) and accelerate drug discovery and development processes.
July 14, 2022
By David Jensen, Staff Writer, MasterControl
Contract Pharma assembled a panel of three seasoned life sciences industry manufacturing experts in a Q&A webinar to address the challenges contract manufacturing organizations (CMOs) have been facing in a pre- and post-COVID-19 pharma manufacturing environment. This post is a recap of that discussion.
July 12, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
To validate or to verify, that is the question medical device developers often wonder about their manufacturing processes. Learn the distinct differences between the two activities, why they’re both essential for compliance, and the circumstances in which each is required.
July 6, 2022
By James Jardine, GxP Lifeline Editor, 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 Love, 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 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, GxP Lifeline Editor, 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.
