MilliporeSigma Case Study

Faster Implementation, Faster ROI: MilliporeSigma’s 97-Day Journey to Operational Efficiency with ValGenesis VLMS

Case in Brief

As part of a global initiative to digitize operations, MilliporeSigma sought to modernize its validation processes with an out-of-the-box solution to improve efficiency, enhance compliance, and reduce manual errors. This case study outlines the fast-track implementation of ValGenesis Validation Lifecycle Management System (VLMS) at the Carlsbad site, completed in just 97 days. By focusing on essential configurations and minimal customization, the system went live quickly, providing immediate benefits to the team.

Results Highlights

• 97 days from kickoff to go-live!

• 100 implementation hours saved using vendor documentation for testing and validation

• 20 to 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

Customer Profile

MilliporeSigma, the life sciences division of Merck KGaA in the U.S. and Canada, is a leading supplier to the global life sciences industry, offering solutions and services for research, biotechnology development, and pharmaceutical drug therapy development and production. Its comprehensive portfolio is designed to help researchers improve efficiency, ensure quality, and drive scientific advancements.

Headquarters: Burlington, MA, U.S.

Employees: 27,000+

Founded: 2015

Featured Solution: ValGenesis VLMS

Accelerating Breakthroughs

Before scientific breakthroughs can happen, researchers need access to cutting-edge tools and expertise. Companies like MilliporeSigma provide the infrastructure to help scientists and manufacturers deliver life-saving innovations. In an industry under constant pressure to reduce time to market while ensuring compliance, the company understands that accelerating internal processes allows its customers to make faster progress.

One critical process that can slow down progress is the cumbersome nature of paper-based validation. The inefficiencies and risks associated with manual processes created operational challenges for MilliporeSigma, prompting the need for a digital solution.

Industry Insights

Companies that provide tools, technologies, and services for laboratory research, biopharmaceutical manufacturing, and diagnostics are crucial in developing new treatments, drugs, and medical devices. Advancements in biotechnology and digital transformation in research and manufacturing are driving growth in this sector.

Despite the optimistic outlook, companies operating in this space face challenges such as regulatory compliance, quality control, and efficiency demands.

To overcome these challenges, many are adopting validation lifecycle management systems. These systems help accelerate product development, reduce manual tasks, and improve operational transparency, providing a critical advantage in a fast-paced, highly regulated market.

Pain Points Behind the Decision to Digitize

Inefficient Trace Matrix Generation

Manually creating and updating trace matrices consumed significant time, requiring repetitive data entry and extensive cross-checking between teams to ensure all validation requirements were accurately mapped. This back-and-forth process caused delays, missed requirements, and noncompliance with industry regulations. The lack of version control in paper-based trace matrices made it difficult to maintain accurate, up-to-date documentation. The company needed a solution that could automate and streamline trace matrix creation, reduce the risk of errors, and improve compliance with regulatory standards.

Inefficient Manual Routing and Approval

Review and approval relied on physically transferring documents, which required moving large binders and files between buildings at the Carlsbad site. This manual process not only slowed workflows but also increased the risk of document loss or misplacement. The lack of real-time tracking compounded inefficiencies. Additionally, manual handling introduced compliance risks with Good Documentation Practices (GDP), such as missing signatures or incorrect versioning.

MilliporeSigma chose ValGenesis VLMS because it was already being used successfully at Merck KGaA sites in Europe. This familiarity, coupled with the system’s ability to deliver a fast, out-of-the-box implementation with minimal configuration, made it the ideal choice.

Validation engineer and project champion Joshua Pelina noted, “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.” – Joshua Pelina, Validation Engineer, MilliporeSigma.

The Implementation Plan: A Structured and Focused Approach

The team strategically limited the implementation to the company’s Carlsbad site to keep the scope manageable. Expanding the project to multiple sites or departments would have required additional resources and approvals, potentially causing delays. By focusing on a single validation activity, site, and department, the team was able to control time, cost, and complexity.

“If we had increased the scope, we wouldn’t have been able to implement the system as quickly. Keeping the scope limited was crucial to making this work with the time and resources we had; we wanted to minimize disruptions to our daily operations,” noted Raghav Mathur, MilliporeSigma senior validation engineer and project co-champion.

Sandeep Lakshmanan, senior project manager at ValGenesis, credited a structured approach and key best practices with keeping the implementation on track. The following examples highlight these best practices in action.

High Customer Engagement

Lakshmanan emphasized that MilliporeSigma’s active involvement was critical to the implementation's success. “Josh and Raghav were very engaged, and their enthusiastic participation played a pivotal role in achieving a fast yet effective roll-out,” he noted.

Eliminating Redundant Testing

One key strategy MilliporeSigma used to accelerate implementation was leveraging the ValGenesis validation package to streamline testing. Instead of conducting exhaustive tests, the team mapped the User Requirements Specification (URS) document to the ValGenesis package, satisfying approximately 80% of the required testing out of the box. They focused only on high-risk areas, building a robust yet efficient Performance Qualification (PQ) package that addressed critical functionality without testing the entire system. This approach reduced the typical 60- to 70-day testing process to just two to three weeks.

“We used ValGenesis’ vendor testing documentation because it was thorough, and it saved us a lot of time,” said Mathur. “We estimate saving 100 hours of work, which we were able to reallocate to other parts of the project, like training.” – Raghav Mathur, Senior Validation Engineer, MilliporeSigma.

Leveraging “Golden Copy”

The team further expedited the system setup by utilizing a pre-configured "golden copy,” a database copy of the validation instance prepared after completing the core data setup. This core data includes categories, subcategories, groups, workflows, roles, templates, and other foundational elements essential to the system. By using the “golden copy” to build the production instance, the team ensured all core data was seamlessly transferred, eliminating the need to rebuild these elements from scratch. This approach not only streamlined the process but also saved approximately two weeks, accelerating the project timeline and go-live date.

Comprehensive Training and Knowledge Transfer

The MilliporeSigma team collaborated closely with Lakshmanan and ValGenesis Business Analyst Eliot Davidson, who provided hands-on instruction on implementation and usage. This included live demonstrations and detailed guidance for mapping MilliporeSigma’s validation processes into the new system. After receiving extensive training from ValGenesis, Mathur and Pelina conducted internal sessions for other team members at the Carlsbad site. Additional Merck KGaA sites are now leveraging their expertise to replicate this approach.

“The key to user adoption was making sure that we, the project champions, were well-trained first,” Mathur explained. “Sandeep and Eliot trained us extensively, which helped us train our colleagues effectively, and we felt well-prepared to handle future rollouts independently.”

Minimizing Process and Configuration Changes

To avoid delays, MilliporeSigma implemented the system "as is," deferring significant changes to existing workflows, processes, or standard operating procedures (SOPs) to a later phase. By focusing on essential configurations and leveraging out-ofthe-box settings, the team achieved its immediate goals without getting bogged down in reengineering business processes or redesigning workflows.

“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.”  – Joshua Pelina, Validation Engineer, MilliporeSigma.

Measurable Outcomes

The implementation of ValGenesis VLMS at MilliporeSigma delivered measurable outcomes that demonstrate both immediate and long-term benefits. Transitioning from a paper-based system to a digital validation solution delivered significant time and cost savings as well as operational efficiency improvements.

Cost Savings

By limiting the initial scope and focusing only on the validation engineering department, MilliporeSigma reduced implementation costs. This decision kept the project within budget and avoided the need for additional resources or approvals for a broader rollout.

Time Savings

Leveraging ValGenesis’ vendor documentation and pre-configured testing templates saved an estimated 100 hours of work, which the team redirected to training and process optimization. Additionally, avoiding system customizations minimized future resource expenses.

Operational Efficiency Gains

Since going live, MilliporeSigma has experienced marked improvements in operational efficiency, including:

• Digitized protocols and executions: Transitioning to a digital system eliminated the need for paper-based protocols and reports, reducing errors and accelerating validation cycles. Automated data collection captures objective evidence in real time, improving accuracy and speeding up processes. Digital execution ensures better data integrity with timestamped entries and secure storage, simplifying data tracking and retrieval.

• Faster review and approval cycles: Previously, physical routing of binders between buildings caused delays and introduced risks such as misplacement or document loss. Tracking approvals in real time was nearly impossible, creating bottlenecks and uncertainty. With ValGenesis VLMS, documents are now routed automatically to appropriate reviewers, with real-time notifications and version control. Reviewers can access the latest documents remotely, drastically reducing cycle times and ensuring compliance.

• Compliant trace matrices: Manually generating trace matrices was slow and prone to errors, often leading to inconsistencies and missed requirements. ValGenesis VLMS automates trace matrix creation, ensuring accurate mapping of validation requirements to test protocols. This automation eliminates errors, accelerates processes, and improves compliance with industry regulations.

• Reduced GDP errors: Centralizing documentation in a digital system drastically reduced GDP errors such as missing signatures and misfiled records. Automated workflows and version control eliminated inconsistencies, prevented unauthorized changes, and ensured traceability. By replacing handwritten records, the system improved legibility and compliance, ensuring accurate and reliable documentation.

• Streamlined validation package assembly: Automating the creation of validation packages significantly reduced the time and errors associated with manual assembly. Critical documents, such as URS, Functional Requirements Specifications (FRS), test protocols, and trace matrices are now generated and cross-referenced automatically, ensuring complete coverage of all requirements. This allows MilliporeSigma to assemble packages faster and with greater accuracy.

Since transitioning to ValGenesis VLMS, MilliporeSigma has achieved significant time and efficiency gains across multiple processes. This improved efficiency has allowed the company to manage growing workloads and meet operational demands without additional staffing.

Expanding Across Sites and Gaining ROI

The successful implementation of ValGenesis VLMS at Carlsbad paved the way for expansion to other sites, including Saint Louis and Indianapolis, laying the foundation for broader adoption across MilliporeSigma’s locations.

In addition to validating computer systems, Mathur and Pelina have extended the use of VLMS to include facility, equipment, instrument, and utility validation, further maximizing the platform’s value. “Since going live last month, we’ve validated four systems and around 20 to 25 pieces of equipment,” Mathur noted.

Mathur also helped establish the implementation of ValGenesis e-Logbook at the Carlsbad site. “We chose ValGenesis e-Logbook because everything is configurable, so we won’t need external developers to make customizations; it’s very cost-effective,” he explained.

MilliporeSigma estimates saving approximately $40,000 in cost efficiency gains in 2025, demonstrating the system’s long-term value. With continued refinement of their processes and expanded use of ValGenesis products, the team anticipates even greater time savings and operational efficiencies in the future.

Key Regulatory Benefits

• Enhanced compliance with FDA 21 CFR Part 11

• Improved data integrity (ALCOA driven)

• Standardized validation processes

• Reduction in GDP errors