Bad habits can be like weeds in the garden, you can get rid of them for a while, but they come right back. In order to successfully break a bad habit, you need to get to the roots. Once you understand habit formation, you can break your bad habits and …
Harmony Platform was built to make it possible for anyone to rapidly build mobile apps for their workforce. Harmony contains many pre-built, configurable components that customers can use to easily …
With the introduction of Progressive Web Apps and web platform APIs such as persistent storage, payments, geolocation, and push notifications, the web platform is taking on native apps. One important …
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…
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…
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…
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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. |
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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While smaller Industrial Equipment Manufacturers may be able to control, access, and share product data with relatively simple Product Data Management (PDM) tools, larger Industrial Equipment Manufacturers rely on full-featured PLM systems that help automate processes and share data across global supply chains.
Industrial Equipment Manufacturer companies may find themselves in-between because:
They need to choose a system that quickly delivers the core capabilities they need to streamline product development but also gives them room to grow value over time. What’s the right size PLM to fit an Industrial Equipment Manufacturer? Let’s take a look. |
If you’re like most employers you want to create a culture that promotes health and wellbeing among your employees. But choosing the right path can be overwhelming, there are so many new tools, programs and services…it’s hard to know where…
