Case Studies
Explore our proven track record of helping life sciences organizations achieve compliance and operational excellence. We work with software development vendors as well as the organizations that use their software — including pharma, biotech, and CROs.
Areas of Focus
- Computer System Validation (CSV)
- ISO 9001 & ISO 27001 Certification
- GxP Compliance & Risk Management
- System Implementation & Integration
- AI in Regulated Environments
- Change Management & Organizational Readiness
Want to See How We Can Help You?
Contact us to learn how these capabilities can apply to your systems, clients, or audit challenges.
Validation Accelerator Implementation Using Valkit for Clinical Tech Vendor
Used Valkit to build a scalable, variable-driven validation accelerator that generates client-specific PQ packages from reusable IQ/OQ baselines.
Fractional VP of Quality Enables Scalable Compliance and ISO 27001 Certification
Provided embedded quality leadership for a regulated SaaS vendor, delivering operational maturity, audit readiness, and scalable compliance infrastructure.
Digital Validation for Technology Vendor
We guided our client, a SaaS software development company, through the transition to Valkit, a digital validation tool, and a new strategy to manage its IQ/OQ processes and deliverables. This combination allowed them to also better support their customers' PQ/UAT needs, which resulted in completing testing efficiently, facilitating more consistent schedule and budget attainment.
ISO 27001 Certification for Laboratory Software Manufacturer
Led ISO 27001 certification for a lab management software vendor serving regulated R&D, GLP, and GMP environments.
System Implementation for Global Medical Information Call Center
Implemented a validated system for global MedInfo operations, integrating with CRM/telephony platforms and improving response times by 25%.
GxP Compliance Initiative for Major Biotechnology Sponsor
Ensured GxP compliance and audit readiness by implementing a tailored QMS and risk-based CSV methodology aligned with GAMP 5.