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How to Transition to Validation 4.0

By Bryan Ennis, Co-Founder & CEO, Sware

The International Society for Pharmaceutical Engineering (ISPE) is providing guidance and best practices to achieve its vision for Pharma 4.0, a future state where organizations leverage the full potential of digitalization to provide faster innovations for the benefit of patients. Our industry’s current approaches to validation are viewed as a key barrier to making the transition to Pharma 4.0 successful. Recognizing this, ISPE is providing guidance on Validation 4.0 to assist the industry in adopting new technologies.

A Validation 4.0 approach provides organization-wide benefits for companies, however, many companies struggle to find a starting point for the implementation. To successfully transition, it's helpful to take a step-by-step approach and embrace communication, education, and intelligent technology.

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