March 15, 2022
By David Butcher, Staff Writer, MasterControl
Deviations are an inevitable part of manufacturing, but the ability to detect and deal with deviations in real time, reduce the occurrence of avoidable deviations, and limit their impact is made more difficult than necessary with paper or disconnected systems. Manufacturers can save themselves a lot of pain by leveraging manufacturing software with robust digital tools to increase operational visibility and manage deviations more effectively.
December 7, 2021
By David Jensen, Staff Writer, MasterControl
Receiving a warning letter involves action items and additional correspondence with the U.S. Food and Drug Administration (FDA). All of which delays your company in getting product out the door. Learn some of the common reasons life sciences companies receive FDA warning letters, so you can avoid making the same mistakes.
August 26, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Global pharmaceutical compounder Fagron is closing in on its goal to align quality across 66 sites worldwide. Discover how expanding the use of its cloud-based quality management system (QMS) to more business units is turning the company’s quality dreams into reality.
September 10, 2020
By David Butcher, Staff Writer, MasterControl
In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.
