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ISPE Launches Good Practice Guide: Validation 4.0 for Digital Manufacturing

The new guide from ISPE offers a digital-age approach to validation. It includes real-life case studies and a self-assessment tool to drive industry progress.

In this image there are people. In the center there is a woman working with the machine and there...
In this image there are people. In the center there is a woman working with the machine and there is a caution paper attached to the machine. Image also consists of wires, papers and also some objects placed in a green container.

ISPE Launches Good Practice Guide: Validation 4.0 for Digital Manufacturing

The International Society for Pharmaceutical Engineering (ISPE) has launched the Good Practice Guide: Validation 4.0. This latest edition, developed with key industry figures like David Margetts, CEO of Factorytalk, offers a modern approach to managing and controlling manufacturing processes in the digital age.

The Guide, which covers methodology considerations, foundational enablers, required capabilities, and real-life case studies, aims to help organizations identify areas for targeted improvements. To facilitate this, a Maturity Self-Assessment Tool is included in the E-Reader for those who purchase the Guide.

While specific publication details are not available, the Guide's release is a significant step forward in digital validation thinking, reflecting the evolving landscape of manufacturing processes.

The ISPE Good Practice Guide: Validation 4.0, with contributions from industry leaders like David Margetts, provides a comprehensive resource for managing and controlling manufacturing processes in a digital world. Its self-assessment tool enables organizations to pinpoint areas for improvement, driving progress in the industry.

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