Biopharma Cuts Validation Effort
by 55% with New Processes

For a lean biopharma organization, commercial success can depend on the ability to balance GxP compliance demands with operational efficiency. A clinical-stage biopharma company faced this exact challenge, managing nine GxP computer systems with just two dedicated leads in its IT and quality teams.

By transitioning from a disjointed and document-centric process to an integrated digital framework, the company transformed its approach to computer system validation (CSV). Its new setup lowered compliance risk and cut administrative burden, freeing teams to focus on technical content rather than manual paperwork.

The hidden burden of legacy validation

In the early stages of its CSV approach, the biopharma lacked easily accessible validation evidence.

The company utilized vendor documentation as a foundational reference. Supplemental validation was required to verify site-specific custom configurations not accounted for in standard materials. To bridge this gap, the team used a hybrid system of electronic documents and e-signing software to manage change controls.

“Digital documents did not equal digital efficiency,” remembers the manager of GxP systems. The manual process of collating evidence across disparate systems, and managing step-by-step sign-offs, was cumbersome and disjointed. Each change control request required approximately 132 hours of manual effort, with 42 hours spent just on preparing and signing master test scripts. This approach made it difficult to track compliance and was confusing for end users.

Driving efficiency with risk-based validation

The quality team sought to streamline validation by aligning effort with the actual level of risk. Their goal was to maximize validation efficiency by replacing manual, disjointed processes with an agile, risk-based approach that incorporated principles from the FDA’s new CSA guidance. In 2023, the company adopted Veeva Validation Management to achieve these objectives.

Instead of continuing to manage processes across multiple systems, the team chose to streamline its workflows. Key validation activities — from change control plans and test script signatures to user acceptance testing (UAT) execution — now happen within a single environment. By also using Veeva QualityDocs for its content management, the company has access to connected and audit-ready vendor and change control documentation as soon as validation work is completed.

“A unified process in Veeva Validation Management simplifies the risk-based CSV approach, and it’s worth the effort. Without it, validation would have continued to be painful for the entire organization.” – Vice President of Quality

Faster validation processes, clear ROI

The business impact of switching to unified digital validation was swift and measurable. The company cut the amount of required resourcing for every change control request from an average of 132 hours to just 60. The time spent preparing and signing test scripts dropped from 42 hours to 20, while document management and collation time fell from 10 hours to just a single hour.

As a result, cycle times today are 20% lower than previously, even as allocated headcount capacity for the work has decreased.

Faster and leaner validation processes have delivered a significant return on investment: $94,000 in savings by the third year. This figure is expected to grow to $300,000 by the end of Year 5.

The investment in centralized, optimized validation processes has proved valuable. The company has maximized operational agility while reducing the burden of GxP compliance. The team is now looking to further strengthen its validation activities by implementing metrics and applying the trending feature of Validation Management for a more proactive, data-driven approach.

To learn more about how digital validation can transform your quality operations, take a look at Veeva Validation Management today.