Author Archive

Putting FDA’s “Process Validation” Guidance into Action

Published by GuestBlogger on May 10, 2012 under Manufacturing, Regulation

Guest blog by Justin O. Neway, PhD., Vice President & Chief Science Officer, Aegis Analytical, jneway@aegiscorp.com

More than a year has passed since the FDA issued its guidance, “Process Validation: General  Principles and Practices,” which describes process validation in three stages – Process Design, Process Qualification and Continued Process Verification. Companies are making progress with how to incorporate these guidelines cost effectively for science-based decision making that improves quality–the consequences of poor quality are too costly. Read more »

IT and Operational Technology Convergence: Are You Ready?

Published by GuestBlogger on March 7, 2012 under Information Technology

Gartner has developed a body of research around the convergence of IT and Operational Technology (OT) and the implications for organizations (1). Much of the research speaks to the opportunities and challenges this convergence presents to organizations. By way of definition operational technology, according to Gartner, refers to “physical-equipment-oriented technology” (e.g., manufacturing equipment) that is shifting from proprietary, hardware-based to open, software-based technology. Thus the lines are becoming blurred as to who “owns” and supports the infrastructure, integration, upgrades, security and analyses of OT software systems. Read more »