RIM System Migration for a Large Global Pharmaceutical Company

Business Process Analysis: Documented existing workflows to establish a process baseline

Gap Analysis: Identified differences between legacy and new system functionalities and proposed optimized solutions

Future Process Design: Developed harmonized and scalable processes aligned with new system capabilities

Field Mapping: Executed detailed mapping of legacy fields to new system structures, ensuring compliance with global standards

Data Migration & Validation: Prepared, cleansed, and validated data for accuracy, completeness, and integrity

System Implementation & Validation Support: Supported configuration, deployment, and validation activities in compliance with 21 CFR Part 11 and Annex 11

Transition Management: Provided hypercare during go-live to resolve issues quickly and maintain business continuity

Complex business processes deeply embedded in the legacy RIM system

Functional disparities between old and new platforms

Large volumes of regulatory data requiring precise mapping and migration

Need for strict validation in line with global regulatory standards

High risk of disruption during transition without coordinated execution

Successfully migrated to a modern RIM platform with zero disruption to ongoing submissions

Delivered harmonized, efficient processes aligned with global best practices

Improved data integrity, accuracy, and traceability across regulatory operations

Ensured the new system was fully validated and audit-ready

Enabled advanced reporting, compliance tracking, and scalability for future regulatory needs