Pharmacovigilance
21 CFR Part 11
EU Annex 11
GAMP 5
SaaS · AWS
Multi-tenant
Mid-sized global PV & clinical services org
Cloud-based multi-tenant SaaS (AWS)
End-to-end CSV & SDLC ownership
A mid-sized global pharmacovigilance and clinical services organization developing a cloud-based, multi-tenant SaaS platform on AWS to support critical safety operations. The platform serves as a high GxP impact system for:
The platform was designed as a high GxP impact system supporting critical safety operations.
As the organization expanded its digital capabilities and prepared to onboard global clients, it needed to formalize and align its validation and SDLC processes with regulatory expectations, specifically:
The goal: position the platform as inspection-ready, scalable, and demonstrably compliant for enterprise and regulatory audiences.
Tech Qualitas was engaged to provide end-to-end ownership of Computer System Validation (CSV) and to establish a structured SDLC framework — covering both the initial implementation and ongoing validation support across release cycles.
Post initial implementation, Tech Qualitas continued as an embedded validation partner across all subsequent release cycles:
Full ownership model — Author, Review, and Execution under one engagement
CSV + SDLC integration — a rare combined capability in the market
Risk-based validation fully aligned to GAMP 5 principles
Continuous validation support across all release cycles, not a one-time engagement
Schedule a consultation with us to discuss your quality and compliance needs. We’re here to answer your questions and explore how we can support your organization.
Founder
