Case study - 2
JILFORA CONSULTING
Vendor Transition & Safety System Migration – Argus to Argus / Argus to ArisG
Client Overview
A well-established pharmaceutical company with a global presence and a large portion of marketed and investigational products. The company manages thousands of ICSRs yearly and relies on Oracle Argus as its core safety database. The client has experienced strategic misalignment and service gaps with its incumbent safety vendor.
Implementation Approach
- Duration: 6 months
- Team: JILFORA safety systems experts, PV business analysts, validation specialists, and regulatory liaisons
Milestone
- Migration planning & risk assessment
- Parallel environment setup
- Data mapping, transformation, and reconciliation
- Regulatory reporting continuity plan
- Post-go-live hypercare and training
Challenges
A. Vendor Issues Impacting Safety Operations
- Inefficiencies, delays, and poor responsiveness from the existing safety vendor
- Lack of flexibility to scale or customer workflows
- Risk of non-compliance due to inconsistent case handling and limited SLA adherence performance
B. Need to Transition Systems
Client decided to switch from:
- Argus (Vendor A) to Argus (Vendor B) - with a new hosting and support model
- On it certain regions, Argus to ArisG - to consolidate systems or due to corporate strategy
Key challenges included:
- Ensuring zero data loss and full case history migration
- Maintaining regulatory compliance and submission continuity
- Revalidating safety systems under the new environment
- Navigating differences in configuration, terminology, and workflows (especially in Argus + ArisG)
Solution
JILFORA was engaged to lead the end-to-end transition, migration, and validation for both migration types
1. Argus to Argus (Vendor Switch)
- Conducted a clean data extraction from legacy Argus Lts backend and API
- Performed controlled migration and reconciliation into new Argus environment
- Retained case numbering, audit trails, and regulatory submission logs
- Executed full system validation (10/00/PPQ) under the new vendor's agenda
- Enabled seamless continuity in E2B(R3) submissions to regulatory agencies
2. Argus to ArisG (Platform Change)
- Mapped Argus data structures to ArisG schema using custom ETL scripts
- Addressed differences in workflow, dictionaries, and configuration
- Designed hybrid operating procedures to support transition period
- Delivered training and support to global PV users during changeover
Client Testimonials
"We were nervous about changing vendors and systems, especially across two platforms. JILFORA's expertise gave us the confidence and structure we needed. We had no compliance gaps and a much smoother operation post-transition."
RESULTS & IMPACT
Project Efficiency
- 100% data integrity achieved during Argus-to-Argus and Argus-to-ArisG migration
- Zero downtime in regulatory submissions during the cutover
Compliance
- Successful system validation and inspection readiness in both platforms
Client Satisfaction
- Improved vendor flexibility and cost efficiency for the client
- PV operations stabilized with measurable performance improvements