Field notes from the front line of quality.
Practical guidance from Globiox SMEs — FDA readiness, auditing, CAPA, validation, and quality systems for regulated life sciences.
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…
June 27, 2024Quality & ValidationStaying 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…
March 13, 2024Company News & EventsEvent: 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…
March 4, 2024Company News & EventsGlobiox 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…
February 19, 2024Quality & ValidationChoosing 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…
January 31, 2024Company News & EventsCultivating 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…
December 19, 2023Company News & EventsGlobiox 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…
May 21, 2021FDA & ComplianceFDA’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…
March 25, 2020Company News & EventsSeptember 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…
September 11, 2019Medical DevicesChallenges 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…
September 10, 2019Company News & EventsFULL – Globiox’s office hours at The University of Texas Dell Medical School CoLab
All sessions are now FULL for Globiox’s office hours at the Texas Health CoLabs on August 15th and 16th, 2019. Check back in September for extended hours…
August 14, 2019Company News & EventsGlobiox’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…
August 12, 2019FDA & ComplianceLatest Updates on Regulatory
Editor’s note (August 2026): On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation, incorporating ISO…
July 30, 2019Medical DevicesClinical Evaluation Reports (CER) –
Written by: Daniel Miranda, Globiox Consultant Clinical evaluation is a critical, ongoing task that must be performed by medical device manufacturers who…
May 30, 2019Medical DevicesAlmost There: Safety and Performance Pathway Option for 510(k) Submissions
Written by: Daniel Miranda, Globiox Consultant On 1/22/2019, the FDA posted their final guidance describing the Safety and Performance Pathway option for…
February 18, 2019Quality & ValidationEquipment validation is not process validation
Editor’s note (August 2026): On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation, incorporating ISO…
June 11, 2014FDA & ComplianceFDA plans major overhaul, looks to be more specialized
5 months ago the FDA announced that in response to “unparalleled challenges” posed by advances in science, globalization and product complexity, the agency…
February 12, 2014InsightsWe do what we do for a reason
There was a talk given at a recent conference by a man named Rick Roberts, who has been a victim of both drug shortages and counterfeit drugs. Mr. Roberts grew…
January 8, 2014FDA & ComplianceCGMP now includes supply chain management
Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 and addresses several areas, including the drug supply…
December 11, 2013AuditingThe FDA’s “dos” and “don’ts” for responding to a 483
DO! • Include photos where possible. • Include documentation to provide evidence that corrective actions have been implemented. • Pay particular attention to…
November 13, 2013Medical DevicesDesign Control
Editor’s note (August 2026): On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation, incorporating ISO…
August 14, 2013Quality & ValidationHigh frequency of CAPA related observations in warning letters
Editor’s note (August 2026): On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation, incorporating ISO…
July 18, 2013Quality & ValidationDon’t let the user manual become the user
Over the years we have had many projects where users have asked us to qualify their laboratory equipment and validate commercial off-the-shelf (COTS) software…
June 12, 2013FDA & ComplianceCombined use diagnostic instruments and the FDA’s thoughts
The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.” The recommendations display intent to…
May 15, 2013Quality & ValidationWhat happens when you can’t test a test?
Test Method Validation (TMV) is a critical part of ensuring quality for manufacturing. This highly specific aspect of validation involves proving that quality…
April 16, 2013FDA & ComplianceKeeping up with the FDA
Quite a few companies in FDA regulated industries are experiencing “Dynamic Shock.” After handling their operations and quality assurance in the same manner…
December 11, 2012FDA & ComplianceWarning Letters: What they are, How we can help
As discussed in our previous post, “FDA 483: your company contains critical errors,” a company whose operations are not compliant with the regulations set out…
October 9, 2012AuditingFDA 483: Does your business contain critical errors?
In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed…
August 22, 2012Ready to get inspection-ready?
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