Global Vaccine Manufacturer Selects ValGenesis to Digitalize Equipment Qualification and Computer System Validation

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis Inc., the global leader in digital validation lifecycle management, today announced that a leading vaccine manufacturer will use its platform to digitalize and standardize equipment qualification and computer system validation (CSV) across regulated manufacturing operations.

The manufacturer selected ValGenesis to support the stringent regulatory expectations inherent to vaccine production — including data integrity, traceability, and audit readiness — while enabling scalable, standardized validation execution across both equipment and control systems. The ValGenesis solution is well suited to support complex qualification and validation activities in highly regulated, high-throughput vaccine manufacturing environments.

The implementation will follow a three-phase rollout. Phase 1 will focus on digitizing equipment qualification and validating associated control systems that support vaccine-manufacturing operations. Phase 2 will expand the use of ValGenesis to include broader, application-level computer system validation. Phase 3 will extend both capabilities to an additional manufacturing site, further strengthening standardization across the organization.

Through this initiative, the vaccine manufacturer aims to transition from paper-based validation processes to a structured, digital validation framework that improves execution efficiency, strengthens end-to-end traceability, and supports consistent compliance with global regulatory requirements. ValGenesis will provide a unified system to manage qualification and validation activities across the vaccine manufacturing lifecycle.

“Vaccine manufacturers operate under some of the most demanding regulatory and quality expectations in the industry,” said Steve Reynolds, chief revenue officer at ValGenesis. “By adopting a phased, digital approach to equipment qualification and computer system validation, this customer is strengthening its validation foundation while enabling greater consistency, scalability, and inspection readiness across sites.”

About ValGenesis Inc.

ValGenesis, Inc., is the global leader in enterprise digital validation. Serving the life sciences industry for nearly two decades, ValGenesis enables companies to digitize their commissioning, qualification, and validation processes through its AI-enabled ValGenesis Smart GxP™ Platform, which includes solutions for risk management, cleaning validation, continued process verification, and CMC development. ValGenesis helps customers worldwide reduce costs, improve compliance, and accelerate innovation. For more information visit: https://www.valgenesis.com/