Factorytalk proudly announces that David Margetts, CEO, served as a co-lead of core team member behind the newly released ISPE Good Practice Guide: Validation 4.0, published by the International Society for Pharmaceutical Engineering (ISPE).
The Validation 4.0 Good Practice Guide encourages progressive thinking and practices toward a continuous demonstration of quality using data. Recognizing that scaling novel medicines such as Cell and Gene therapies relies heavily on modern applications of Quality by Design (QbD), the guide thoughtfully builds on historical validation initiatives, placing them within a contemporary digital context.
David’s role on the guide’s core team underscores Factorytalk’s leadership and commitment to innovation in the life sciences sector. His contribution specifically addresses practical strategies for pharmaceutical manufacturers adopting Validation 4.0 methods, aiming for improved regulatory compliance, operational agility, and continuous quality assurance through data-driven processes.
” Validation 4.0 represents the significant need to advance in how we approach quality and compliance,” commented David. ” It’s designed to aid the industry with insight, case studies and tools to embrace digital transformation and continuous improvement confidently.”
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About Factorytalk
Factorytalk delivers digital solutions and regulatory expertise to life sciences manufacturers, supporting their journey toward Pharma 4.0 through practical, innovative applications such as Lite MES, eQMS, and advanced validation and compliance services.
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