Mid-Size Pharmaceutical Manufacturer
Oracle EBS to Fusion ERP migration for an FDA-audited pharma manufacturer.
All case studiesA mid-size pharmaceutical manufacturer operating two formulation plants in Maharashtra engaged Cydez Technologies to execute a full Oracle EBS to Oracle Fusion ERP migration. The company produced over 300 SKUs across oral solids, injectables, and topical formulations — all subject to FDA and CDSCO regulatory requirements including 21 CFR Part 11 compliance for electronic batch records.
The existing Oracle EBS 12.1 instance had been heavily customised over 9 years with 45 custom extensions covering batch tracking, quality hold workflows, stability study scheduling, and regulatory submission data capture. The system was approaching end-of-support, and a recent FDA audit had flagged gaps in electronic batch record traceability — specifically, the inability to produce complete genealogy from raw material receipt to finished goods release within a single query.
Cydez executed the migration covering Oracle Fusion Financials (GL, AP, AR, FA), Procurement, Inventory Management, and Cloud Manufacturing. Batch genealogy was re-implemented using Oracle Cloud Manufacturing with lot and serial tracking, replacing 12 of the 45 custom extensions with standard Fusion functionality. The remaining custom requirements were addressed through Oracle VBCS extensions and OIC integrations with the laboratory information management system (LIMS) and the quality management system. Data migration of 7 years of transactional history was executed using FBDI and HDL tools with a 99.6% first-pass accuracy rate.
- Oracle EBS to Fusion ERP full migration
- FDA 21 CFR Part 11 compliance implementation
- Batch genealogy and lot tracking configuration
- LIMS and QMS integration via OIC
- 7-year transactional data migration
- 45 custom extension rationalisation
A mid-size pharmaceutical manufacturer operating two formulation plants was running Oracle EBS 12.1 with heavily customised modules for batch tracking, quality holds, and regulatory reporting. The system was approaching end-of-support, and FDA audit observations had flagged gaps in electronic batch record traceability and 21 CFR Part 11 compliance.
Cydez executed a full Oracle EBS to Oracle Fusion ERP migration covering Financials, Procurement, Inventory, and Manufacturing. Batch genealogy and quality hold workflows were re-implemented using Oracle Cloud Manufacturing with FBDI-based data migration. Integration with the laboratory information management system was built on OIC, ensuring end-to-end traceability from raw material receipt to finished goods release.
How we delivered this project
Discovery
Conducted 8-week assessment of the EBS instance, cataloging 45 custom extensions and mapping each to standard Fusion functionality or required customisation. Documented FDA compliance gaps and batch traceability requirements with the quality assurance team.
Design
Designed the Fusion ERP configuration blueprint with batch manufacturing workflows. Created the LIMS and QMS integration architecture on OIC. Defined data migration strategy for 7 years of transactional data with validation checkpoints.
Development
Configured Oracle Fusion ERP modules with pharmaceutical-specific batch tracking. Built 8 OIC integration flows for LIMS and QMS connectivity. Developed VBCS extensions for stability study scheduling and regulatory data capture. Executed 3 rounds of data migration testing.
Launch
Executed cutover over a planned 72-hour production shutdown weekend. Migrated 7 years of data with 99.6% first-pass accuracy. Conducted parallel-run for 30 days. Trained 120 users across manufacturing, quality, finance, and procurement. Decommissioned EBS after 90-day stabilisation period.
What we built
Batch Genealogy Tracking
Complete raw material to finished goods traceability using Oracle Cloud Manufacturing lot and serial tracking. Single-query batch genealogy for FDA audit readiness.
21 CFR Part 11 Compliance
Electronic signatures, audit trails, and access controls configured to meet FDA 21 CFR Part 11 requirements for electronic batch records and quality documents.
LIMS Integration
OIC-based bi-directional integration with the laboratory information management system for sample submission, test results, and quality release workflows.
Quality Hold Management
Automated quality hold and release workflows triggered by out-of-spec test results, with notification chains to quality assurance and production management.
Custom Extension Rationalisation
45 EBS custom extensions analysed — 12 replaced with standard Fusion features, 18 rebuilt as VBCS extensions, and 15 eliminated through process redesign.
Regulatory Reporting
Automated generation of CDSCO and FDA regulatory reports including batch production records, deviation reports, and stability study data.
Measurable outcomes
- Zero FDA observations on electronic batch records post-migration
- 40% reduction in batch release cycle time
- 100% traceability from raw material to finished product
- EBS decommissioned 90 days after go-live with zero data loss
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