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Digital Validation - Navigating change in Life Sciences
28/10/2025

Digital Validation - Navigating change in Life Sciences

Faster, safer, more sustainable validation

Michael Sweeney

CQV EVal Lead

Michael is PM Group’s CQV EVAL lead with over 10 years' experience in CQV. In this role, he manages PM Group’s Kneat instance and supports clients in the delivery of their own Kneat instance, bringing power user experience and the understanding of potential efficiencies and road blocks.

Paper-based validation: slow, risky and overdue for change.

Despite advances in technology, many life sciences organisations still face slow, manual validation processes, error-prone paperwork and stressful audits. As regulatory expectations tighten, these challenges are only becoming more acute. 

Teams relying on paper-based systems face delays, increased risk of mistakes and a constant scramble to stay audit-ready. These aren’t isolated issues - they’re industry-wide pain points that threaten project timelines and compliance.

The Solution: Digital workflows that deliver

The industry is responding. Digital validation platforms are no longer a “nice to have” - they’re essential. By moving to electronic systems, CQV teams can: 

  • Slash document preparation time 
  • Reduce human error and improve data accuracy and strengthen ALCOA+ principles and data integrity 
  • Enable real-time approvals and instant access to records 
Michael Sweeney
Michael Sweeney background

“Electronic validation (EVal) isn’t just about efficiency - it’s about building a foundation for operational readiness and compliance.”

Michael Sweeney

CQV EVal Lead

Digital workflows mean managers and QA teams have real-time visibility, can intervene early and keep projects on track.

Watch Michael Sweeney share his perspective on digital validation:


Standardisation and Scalability

Sustainability and Integration

Global operations demand consistency. Digital platforms with template libraries and standard protocols make it possible to deliver a “right first-time” approach, no matter where teams are based. This not only speeds up training and reporting but also ensures quality is never compromised as organisations scale. 

Paperless validation isn’t just good for the environment - it’s good for business. Reducing waste, supporting sustainability goals and enabling seamless integration between platforms, all contribute to a more agile, future-ready organisation. 

Turning challenge into opportunity

The shift to digital validation is about more than technology - it’s about empowering teams to meet today’s demands and seize tomorrow’s opportunities. As regulatory landscapes evolve and expectations rise, those who embrace digital transformation will set the pace for the industry. 

At PM Group, we don’t just implement digital solutions - we bring decades of CQV experience, a proven global template library and a deep understanding of both operational and regulatory realities. 

Our partnership with Kneat means clients benefit from best-in-class digital platforms, tailored to real-world CQV challenges. Through EVal and our integrated project dashboards, clients gain real-time schedule visibility and a single source of truth for validation management. 

Together, we help teams work smarter, faster and with greater confidence - delivering validation that’s not just compliant, but truly competitive. 

Discover how our CQV experts can support your digital validation journey.

See CQV Services