With over 12+ years of pharma industry experience, we have strong capabilities to support ongoing change management of GxP critical process management systems, data platforms and related applications. Based on your validation needs, we have different service models to deliver high quality deliverables using industry best practices and ready-to-use validation accelerators.
Our Validation Framework
Provide Inputs to Cross-Functional Teams for Business Process Design
Offer Ready-to-Use Validation Kits prepared using GAMP-5 Principles
Provide Accountability for 21 CFR Part 11, EU Annex 11, GDPR, HIPAA compliance
Deliver audit-ready validation deliverables for the target GxP system
Provide hands-on application training to End-users and System Administrators
Orchestrate phased Global Solution Rollout with a centralized Deployment Plan