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Case Study: A Greenfield CDMO in California Achieves Continuous Validation

To drive growth and become a premier CDMO, Theragent needed to get their state-of-the-art smart manufacturing facility up and running as quickly as possible without compromising safety or compliance.

In this case study, Chief Operating Officer Jeff Masten explains why the company wanted ValGenesis VLMS from day one of operations to achieve a continuous state of validation and secure confidence among clients who entrust them with the care of their assets.

The Real-World Benefits that Mattered to Theragent

No delays waiting for validation. Removing the bottleneck of paper gets resources like equipment and cleanrooms into production at the speed of business.

Streamlining inspections. FDA investigators already familiar with the industry-standard ValGenesis appreciate a single standardized tool with robust audit trails tracking the creation, modification and deletion of records.

Attracting digital-minded talent. Prospective talent appreciate a digital-first, zero-paper approach to validation, enabling them to focus on the science and the client.

Competitive differentiation. Customer service excellence matters with CDMOs, and deploying the industry-standard VLMS sitewide impresses clients.

Man Using Laptop Inside a Lab

Digitizing validation empowers you to:

  • Ensure compliance and quality with templates
  • Route and approve with digital workflows
  • Collaborate and complete work from anywhere
  • Finally get rid of the headaches of paper

See how Theragent accomplished all of this in their case study.

The benefits of a Validation Lifecycle Management System (VLMS) for paperless validation can be clearly quantified ...

50%less

cost in your regulated project's validation expense

67%faster

protocol cycle times while retaining ALCOA data integrity

90%fewer

validation-related observations with compliant, consistent templates

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FDA 21 CFR Part 11 Compliant
EU Annex 11 Compliant
ISPE GAMP 5 Certified
SOC 2 Type 11 Compliant
ISO 27001 Certified