Streamlining Validation to Save Over $130K Annually and Accelerate Compliance

Solution

Standardized Validation

Res_Q established a single source of truth for all validation documentation, replacing fragmented, facility-specific processes.

Unified Dashboard

Leadership gained full organizational visibility into validation status for the first time.

Scalable Platform

Res_Q supported Andelyn’s acquisition-driven growth strategy, enabling new projects and facilities to onboard without adding headcount.

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The old way involved more documentation and less critical thinking. The shift from CSV to computer systems assurance (CSA) turned this model on its head. Now, we succeed with less documentation and more critical thinking. With Res_Q, a project requiring 15 validation packages has now been reduced to less than 10.”

VP of QA and Digital Systems
Pharmaceutical Research Company

Results

53%

Reduction in effort per project using Res_Q

$130K

Projected annual labor savings

2,070 hours

Saved annually—equivalent to 1 FTE

Accelerated Compliance

Test execution sped up by 20–40%, and approval cycles reduced from weeks to days.

Early Wins

Three critical SaaS systems validated successfully, earning early FDA approvals.

Future Collaboration

The CDMO plans to integrate Res_Q with equipment using BM RAM, further enhancing operational efficiency.
The partnership will continue to evolve as the CDMO scales its operations, ensuring compliance and innovation remain at the forefront.
Sware and the CDMO are committed to a long-term collaboration, leveraging Res_Q to meet future challenges and maintain the CDMO's position as a leader in gene therapy manufacturing.