Launching Digital Validation: MilliporeSigma's 97-Day Implementation Success Story

Efficiency and compliance are critical in life sciences, yet outdated paper-based validation processes put both at risk. MilliporeSigma, the life sciences division of Merck KGaA in the U.S. and Canada, needed a faster, more reliable way to manage validation activities—so they turned to ValGenesis VLMS. In just 97 days, the Carlsbad site transitioned to digital validation, reducing manual effort and accelerating ROI. This post highlights key takeaways from their implementation journey.

The Need for Digital Validation

• Inefficient trace matrix generation: Manually creating and updating trace matrices required repetitive data entry and extensive cross-checking between teams, leading to delays, missed requirements, and compliance risks. Paper-based trace matrices also lacked version control, making updates challenging and error-prone.
   
• Cumbersome approval processes: Routing physical documents between buildings slowed workflows and increased the likelihood of misplaced files. The lack of real-time tracking led to approval bottlenecks, while manual handling introduced GDP compliance risks.

ValGenesis VLMS offered a proven digital solution to streamline validation and decrease manual effort. With ValGenesis already in use at Merck KGaA’s sites in Europe, MilliporeSigma saw it as the right choice.

“We chose ValGenesis because they were a known and trusted vendor. We had limited time and resources, and we knew the quicker we could implement the solution, the sooner we’d start realizing value from it,” said Joshua Pelina, Validation Engineer.

A Strategic, Focused Implementation

MilliporeSigma limited the initial implementation scope, focusing on a single validation activity (computer system validation), site (Carlsbad), and department (validation engineering). This approach kept the project on track without disrupting daily operations.

"Keeping the scope limited was crucial to making this work with the time and resources we had,” said Raghav Mathur, Senior Validation Engineer. “We wanted to minimize disruptions to our daily operations."

Best Practices for Fast Deployment 

• Active customer engagement: MilliporeSigma’s internal project champions were deeply involved throughout the rollout, taking ownership of key implementation tasks, facilitating cross-team collaboration, and ensuring smooth adoption. Their proactive engagement helped accelerate decision-making, address challenges in real time, and foster strong internal support for the new system.
   
• Comprehensive training: Hands-on training sessions with the ValGenesis Professional Services team equipped Mathur and Pelina with the expertise to manage future expansions independently. Additional Merck KGaA sites are now utilizing their knowledge to replicate the approach.
   
• Leveraging 'golden copy': The team leveraged a pre-configured 'golden copy'—a database copy of the validation instance prepared after completing the core data setup. By using this copy to build the production instance, they seamlessly transferred all core data, eliminating the need to recreate critical elements. This approach not only streamlined the setup process but also saved approximately two weeks, accelerating the overall project timeline and go-live date.
  
  
• Eliminated redundant testing: Using ValGenesis’ validation package reduced testing time, saving approximately 100 hours.
   
• Minimized process and configuration changes: Implementing the system ‘as is’ prevented delays, with major process changes deferred to a later phase. 

"Sticking to our initial scope was challenging once we saw how effective the system could be," said Pelina. "But we learned it's better to focus on key processes first. After the initial success, we were able to expand the system to other areas and processes, which has made the system even more valuable." 

Many companies struggle with lengthy system rollouts, facing months of configuration and unexpected roadblocks. By prioritizing essential features and leveraging ValGenesis' out-of-the-box settings, MilliporeSigma streamlined validation workflows and achieved operational efficiency in record time.

Immediate and Long-Term Benefits

• Cost savings: By focusing on the validation engineering department first, MilliporeSigma reduced implementation costs and avoided the need for additional resources or approvals for a broader rollout.
   
• Time savings: Using ValGenesis’ vendor documentation and pre-configured testing templates saved 100 implementation hours, allowing more time for training and optimization. Additionally, avoiding system customizations minimized future resource expenses.
   
• Operational efficiency gains: Digital validation streamlined protocol execution, automated trace matrices, and eliminated manual bottlenecks in review and approvals. Automated workflows improved compliance by reducing GDP errors, ensuring version control, and enhancing data traceability. The transition also accelerated validation package assembly, cutting manual effort while improving accuracy and completeness.

Scaling Success Across Sites

Following the successful implementation at Carlsbad, MilliporeSigma expanded the use of ValGenesis VLMS to additional validation activities—including facility, equipment, instrument, and utility validation—and sites—including St. Louis and Indianapolis. They also adopted ValGenesis e-Logbook at Carlsbad. 

ValGenesis e-Logbook is designed to replace traditional paper-based logbooks in GMP environments. It enables teams to securely track equipment usage, cleaning, calibration, and maintenance across devices, ensuring real-time data accuracy and compliance. With automated workflows, business rules, and offline execution capabilities, the solution enhances data integrity while eliminating the inefficiencies of handwritten records. 

“We chose ValGenesis e-Logbook because everything is configurable, so we won’t need external developers to make customizations,” explained Mathur. “It’s very cost-effective.”

Unlocking the Value of Digital Validation

MilliporeSigma’s rapid deployment of ValGenesis VLMS highlights how digital validation transforms workflows and delivers fast ROI. Their approach offers a roadmap for organizations looking to fast-track validation, improve compliance, and enhance operational efficiency while minimizing disruption to daily activities. 

Results Highlights:

• 97 days from kickoff to go-live 
• 100 implementation hours saved using vendor documentation for testing and validation 
• 20–25 hours per week saved by shifting from manual to digital processes 
• Recouped 50% of investment in 20 weeks  
• Significant improvement in data integrity, compliance, and validation execution and review process time