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,
Category: Services
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
Clinical 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 market products in the European Union and seek to obtain or maintain a CE mark. This task is completed via creation of a clinical evaluation report (CER). A CER must be created prior
We 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 up in small town in the US. Due to health problems, he had an inhaler from age one. Because of this, he had many trips
CGMP 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 chain. The FDA regulates products from more than 150 countries. There are over 130,000 importers into the US, with over 300,000 foreign facilities providing these goods. FDA regulated shipments at more
Design Control
Out of 99 Warning Letters issued to Medical Device companies in 2013 (up to July 3rd, 2013), 50 have contained observations relating to Design Control (21 CFR 820.30) deficiencies, with a total of 85 observations. The three subcategories that received the most attention are (f)Design Verification (12 observations, or 24% of the Medical Device related
Don’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. Sounds pretty straight forward, right? But when we look at the customer’s user requirements documents, we realized that they were derived from user manuals and specification sheets that manufacturers provide for
Combined 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 mitigate interference in molecular diagnostic instruments with combined FDA approved device functions and functions in which FDA approval is not required, and furthermore prevent confusion for the end user. While following the guideline should serve