September 15, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
When it comes to avoiding FDA Form 483s and getting 510(k) clearance for medical devices faster, Northeast Scientific has cracked the code. Find out how the leader in medical catheter reprocessing has fast-tracked regulatory success and eliminated lag points.
September 14, 2022
By Becky Blankenship, Technical Writer, Cannon Quality Group
Every medical device company is faced with the challenge of navigating the FDA’s quality system requirements. Cannon Quality Group shares four compliance best practices that help make the regulatory road less rocky.
September 8, 2022
By David Butcher, Staff Writer, MasterControl
ISO 9001:2015 is one of the most recognized standards in the world. Among the goals of the quality management system (QMS) standard is to enhance requirements for addressing QMS change management.
September 6, 2022
By Johanna Blair, Staff Writer, MasterControl
The scope of a quality management system (QMS) can look very different depending on the size and goals of a company. However, following ISO 9001 standards for documentation can benefit any system.
August 30, 2022
By Johanna Blair, Staff Writer, MasterControl
The FDA is paying more and more attention to life sciences companies data management deficiencies. Following these five suggestions can help your organization prevent data integrity failures and strengthen CGMP compliance.
August 25, 2022
By Brian Curran, Senior VP of Strategic Growth, MasterControl
While many manufacturers in medical technology manufacturing think they have an electronic device history record (eDHR) system, often it is incomplete because it still relies at least in part on paper. Whereas an incomplete eDHR system offers insufficient visibility, traceability, and data integrity, a complete eDHR solution enables smarter, faster manufacturing processes.
August 17, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Biopharma is rapidly becoming the most dynamic sector in the life sciences. But explosive growth brings new challenges in an industry dependent on contract manufacturing. Find out which market-changing trends you need to be aware of and what the future holds for biopharma contract manufacturers and their clients.
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.
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.
