Step-by-Step Strategies for Effective REMS Audit Preparation

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.

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

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,

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

Challenges of the Medical Device Market for New Manufacturers

Written by: Andrey Grishin, MD, Globiox Consultant Ensuring Quality of the Final Product. Every Medical device manufacturer must guaranty high product quality to avoid costly product recalls and legal issues which can also pose risk to the public. Product recall negatively impacts its brand reputation and the company’s bottom line. Ensuring required product safety, security

Globiox’s Office Hours at The University of Texas Health CoLab

Globiox is excited to announce office hours at The University of Texas Health CoLab to meet with aspiring life science companies for 1 hour consultations 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