Fiber optic cabling is often required when extending industrial networks to monitor or control remote assets where distance, environmental factors or signal speed requirements preclude the use of copper cable or wireless solutions. Incorporating fib…
Fiber optic cabling is often required when extending industrial networks to monitor or control remote assets where distance, environmental factors or signal speed requirements preclude the use of copper cable or wireless solutions. Incorporating fib…
The use of sensors in critical applications is proliferating, driven by the increasing market pressure to extract more value out of existing resources and the increasing push of the Internet of Things (IoT) into industrial markets. Critical application…
The use of sensors in critical applications is proliferating, driven by the increasing market pressure to extract more value out of existing resources and the increasing push of the Internet of Things (IoT) into industrial markets. Critical application…
The U.S. Food and Drug Administration (FDA) issues Form 483 Inspectional Observations or warning letters when communicating to a pharmaceutical company that its quality practices are not in compliance with regulatory standards. Most of these observatio…
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As clinical trials continue to expand globally, technology plays a critical role in maintaining data integrity and at the same time accelerating study start-up. Consider a study management team that must travel globally to hold investigator meetings. Given that clinical trials in Asia had experienced 30% average annual growth from 2005 to 2012, travel takes up a much greater portion of the study management team’s time and energy. That’s why study teams have turned to technology to reduce this effort – from preclinical R&D and regulatory communication to packaging/distribution and postmarketing studies.
To be successful, site personnel qualification technology must be targeted to each role within the clinical research site. Otherwise, each individual within the site would receive too much or not the right material that pertains to their function within the study. As a provider of clinical site qualification technologies to the Life Sciences industry, UL Compliance to Performance has identified four guiding rules for structuring an automated Clinical Qualification solution within a company’s clinical system architecture. |
Santos-Serrao is a member of the Regulatory Affairs Professional Society (RAPS) and the Drug Information Association (DIA) and has nearly two decades of experience in the regulatory affairs and clinical areas of the pharmaceutical industry. Following h…
While the information required is essentially the same for various registrations as many countries have adopted the Electronic Common Technical Document (eCTD) standard, the preparation, presentation, and the depth of information submitted vary greatly…
The guidelines set forth by the FDA are a major factor in ensuring that pharmaceutical companies manufacture and sell products that are safe, reliable, and effective. Compliance with FDA regulations is simply just a part of doing business for pharmaceu…
Linux Server Security: Hack and Defend presents a detailed guide for experienced admins, aspiring hackers and other IT professionals seeking a more advanced understanding of Linux security. Written by a 20-year veteran of Linux server deployment this b…
