Written by: Patti Rossman Preparing for a REMS (Risk Evaluation and Mitigation Strategies) audit can be a daunting task, but with the right approach, it can be manageable and even straightforward. Whether you are a vendor or a service provider, ensuring compliance with REMS requirements is crucial for maintaining regulatory standards and delivering quality services. Read More
Blog
Staying Ahead: Navigating Timely Training and Version Control in Pharmaceuticals and Medical Devices
written by: Jenny Azarh In the dynamic world of Pharmaceuticals and Medical Devices, maintaining regulatory compliance and ensuring the highest standards of quality is crucial for ensuring patient safety. Throughout 2023, Globiox auditors conducted over 40 quality audits, revealing a recurring issue within the industry: overdue training and delayed training acknowledgments. This common challenge underscores Read More
Event: Register Today for ‘Building a Medical Device Quality Management System with Limited Resources’
Make the most out of BioFest Days and join us for an enlightening session hosted by Globiox, where seasoned subject matter experts (SMEs) share their wealth of knowledge on implementing a Quality Management System (QMS) for the medical device industry. 🔍 What to Expect: Panel Overview: Globiox SMEs will guide you through the intricacies of building Read More
Globiox Stands Up and Stands Out at Biofest Invest
Globiox, a premier quality assurance firm, takes the stage as a presenting sponsor of Biofest Invest, reaffirming its commitment to innovation, growth, and collaboration within central Texas’ vibrant life sciences ecosystem. San Antonio, TX – Globiox, a technical quality assurance consulting firm headquartered in Austin, Texas, announces its role as presenting sponsor for Biofest Invest, Read More
Globiox Stands Up and Stands Out at BioFest Invest
Globiox, a premier quality assurance firm, takes the stage as a presenting sponsor of Biofest Invest, reaffirming its commitment to innovation, growth, and collaboration within central Texas’ vibrant life sciences ecosystem. San Antonio, TX – Globiox, a technical quality assurance consulting firm headquartered in Austin, Texas, announces its role as presenting sponsor for Biofest Invest, Read More
Choosing the Right EQMS: Key Considerations in Quality Management System Selection
Written by: Steve Norris The terms “enterprise quality management system” (EQMS) and “electronic quality management system”(eQMS) are often used interchangeably, but they may have subtle differences in interpretation depending on context. Here’s a general distinction between the two: Electronic Quality Management System (eQMS): An Electronic Quality Management System, as the name suggests, primarily emphasizes the Read More
Cultivating Peace and Harmony: Celebrating a Year of Impact in Life Science
As we approach the end of this remarkable year, we’d like to take a moment to express our heartfelt appreciation for the journey we’ve shared with our invaluable customers. In the ever-evolving landscape of life sciences, where each discovery has the potential to transform lives, we’re deeply grateful for the privilege of being a small Read More
Globiox Launches Free Consultations
We are proud to announce our launch of virtual office hours for 2021. Meeting with a Globiox subject matter expert has never been more simple. If you have questions for one of our SMEs just go over to our booking page, select an available date/time, and you will be connected with an expert. You will Read More
FDA’s Data Integrity citation trends of Biological Products
During the 2016-2018 period, the FDA performed routine inspections of the Biologics and Human Cellular and Tissue Products (HCT/P) facilities in the US and collected Biologics Product Deviation Reports (BPDRs) from the corresponding facilities. The statistical data of the incidents are presented in table 1. Table 1. The trend in BPDR issuance by the FDA Read More
September Office Hours At The University of Texas Dell Medical School CoLab
We are now offering office hours at The University of Texas Health CoLab to meet with aspiring life science companies for 1 hour consultations (FREE) regarding Quality Management Systems, GxP Audits, Regulatory Strategy, Operations Support, Information Technology, Computer System Validation, Equipment Qualification, Facilities Qualification, and Clinical Services. ***Reservations are made through the dellmed.utexas.edu website (provided Read More