ProductLife Group at ISPE Pharma 4.0 Conference

At the ISPE Pharma 4.0 Conference, pharmaceutical and biopharmaceutical leaders, regulators and technology providers converge to explore how digital transformation, automation and AI reshape manufacturing, quality and supply resilience.  
Within this ecosystem, ProductLife Group and its affiliate LifeBee hold a central role as content leaders, connecting strategic vision, regulatory insight and practical implementation. 

As Conference Chair, Teresa Minero of LifeBee | a ProductLife Group Company guides the overall programme and moderates the Regulatory and Industry Panel Digital Transformation Advanced Manufacturing and AI, where senior representatives from authorities and global companies discuss how innovation can remain both compliant and value driven.  

Meanwhile, Livia Cerruti contributes to the Women in Pharma Program with a focus on next generation skills and AI, highlighting how digital native talent and intelligent technologies reshape decision paths, roles and organisational models in Life Sciences. 

Together, these contributions position PLG not only as a participant in the dialogue but as a reference point for interpretation and direction on what Pharma 4.0 means in real operations. 

LifeBee and PLG contribute to the ISPE Pharma 4.0 survey, which tracks digital maturity, enabling technology adoption, benefits and challenges as seen by Life Science organisations worldwide.
The analysis of these results helps companies understand where they stand on the Pharma 4.0 journey and what realistic next steps look like. 

Conference themes such as data driven quality, PAT and real time control, smart facility design and AI case studies echo questions that PLG teams encounter in projects every day.
This direct link between industry discussion and field experience allows PLG to translate high level concepts into structured roadmaps, tailored to each organisation’s constraints, legacy systems and regulatory context. 

Across PLG and its affiliates, multidisciplinary teams support clients in areas that align closely with Pharma 4.0 priorities 

• Digital strategy for GxP environments with governance models that connect IT OT Quality and Operations 

• Quality 4.0 and digital QMS evolution with a focus on data integrity, Annex 11 and Part 11 expectations  

• Computer System Validation and digital validation with risk based approaches suitable for cloud, platform solutions and AI enabled tools 

• Data and analytics foundations that turn process and quality data into actionable insights rather than isolated dashboards 

• Operational support for MES LIMS and eBR projects so that technology adoption remains inspectable and aligned with daily GMP practice 

Through this combination of strategy, methodology and execution support, PLG helps organisations avoid fragmented initiatives and instead build coherent transformation programmes that regulators can understand and trust. 

For companies that face pressure to modernise plants, scale innovative therapies and keep compliance under control, PLG offers 

• A bridge between vision and operations thanks to experts who work both in international forums and on site with client teams 

• Independent insight on technology choices grounded in regulation, risk and long term sustainability 

• Proven experience across countries and product types from biologics and sterile products to complex devices and data intensive platforms 

Through its role at the ISPE Pharma 4.0 Conference and through project work worldwide, ProductLife Group supports Life Sciences organisations in turning Pharma 4.0 from a concept into reliable, inspectable and value generating reality. 

If you are interested or would like to explore further, contact us