ISPE's New Guide: Validation 4.0 for Digital Manufacturing
ISPE's latest publication, The Good Practice Guide: Validation 4.0, is now available. Co-authored by David Margetts, CEO of Factorytalk, this guide introduces modern validation thinking for digital manufacturing processes. Purchasers receive an E-Reader with a Maturity Self-Assessment Tool for targeted improvements.
Published around September 2023, the guide is part of ISPE's digital transformation efforts in pharmaceutical validation. It covers methodology considerations, foundational enablers, and required capabilities for managing and controlling digital manufacturing processes. Real-life case studies illustrate the practical application of these concepts.
The included Maturity Self-Assessment Tool helps organizations evaluate their current validation practices. It identifies areas for targeted improvements, enabling companies to enhance their validation maturity.
The Good Practice Guide: Validation 4.0, co-authored by David Margetts, provides a roadmap for digital manufacturing processes. With the Maturity Self-Assessment Tool, purchasers can assess their validation capabilities and make informed improvements. This guide is a valuable resource for pharmaceutical companies navigating digital transformation.
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