Newly released is the Spring edition of Journal of GXP Compliance. Vol. 22, Issue 2 addresses some of the most pressing issues in GMP, by experts with unique perspectives and a knack for storytelling. Included is a preview of our upcoming Medical Device Validation Handbook, an investigation of fungal contamination, a paper on the software development lifecycle, and more.
Institute of Validation Technology (IVT)
Mar 21 2018 - 12:34 pm
This paper considers the selection and adoption of automated, digital capture colony counters within the pharmaceutical microbiology laboratory. The focus is on how such devices can be qualified (or...
Feb 28 2018 - 9:02 am
This whitepaper summarizes the challenges found in the traditional validation process and the benefits achieved by implementing Validation Lifecycle Management Systems (VLMS).
Mar 6 2018 - 1:38 pm
In an era of rapid and sustained technological advances that outpace our ability to predict impact,risk management is a core competency for innovators and businesspersons alike.
Mar 21 2018 - 12:19 pm
In the waterfall approach developers are sometimes not aware of the challenges when designing the software which may require changing the design instead of continuing the software development process...
Mar 21 2018 - 1:43 pm
Process validation begins with determining risk, not only in the manufacturing process but also in the design and use of the device. Risk assessment and management is the logical foundation of...