April 6, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
If nothing else, the COVID-19 pandemic proved to pharmaceutical companies that digitally integrated processes are the key to surviving a crisis. If your organization has difficulty connecting people, processes, and systems, there are three pragmatic measures you can take to bolster your existing infrastructure, help ensure secure connections, and enhance collaborative work.
August 20, 2020
By David Butcher, Staff Writer, MasterControl
When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.
May 31, 2018
By Philippe Charbon, President, Apsalys
An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.
May 29, 2018
By Philippe Charbon, President, Apsalys
The emergence of new guidelines on data integrity, and the interpretation of that data via audits and inspections, doesn't detract from pre-existing elements of regulation, particularly Annex 11 of the European Union’s (EU) good manufacturing practice (GMP) guidelines.
June 28, 2016
By James Jardine, GxP Lifeline Editor, MasterControl
Call it the curse of success: as Unity Lab Services—a business unit of Thermo Fisher—flourished, the already massive amount of vital documentation that required tracking, continual updating and maintenance became exponentially larger and more difficult to manage. For a company that has obtained its leading edge by providing customers with a single source for integrated lab services, support and supply management, the very notion of out-of-control documents and outdated, rogue work instructions spelled potential disaster.
