Image
In MedTech manufacturing enterprises, fragmented ERP systems can severely hinder operational efficiency, regulatory compliance, and scalability, especially following mergers and expansion projects.
Our client, a global medical device manufacturer with operations across multiple regulated facilities, faced challenges from disparate JD Edwards instances and inconsistent compliance frameworks. The client engaged Birlasoft to consolidate their deployments into a single JDE 9.2 platform to unify their ERP landscape and accelerate digital transformation. This enabled faster manufacturing transfers, improved regulatory alignment, and established a scalable model for future rollouts.
Read how Birlasoft enabled this transformation below.
The Challenge
#1. Fragmented ERP landscape limited scalability and delayed transformation
The client operated on multiple legacy JD Edwards environments across global manufacturing sites. Each site had its own customizations, integrations, and data models.
This fragmented architecture made it difficult to establish centralized governance, enable cross-site visibility, or drive consistent user experiences. It also inflated the cost and effort of change, making strategic IT modernization nearly impossible to execute at scale.
#2. Compliance misalignment increased regulatory risk and cost overhead
Following multiple mergers, each site followed different FDA compliance protocols, validation models, and documentation standards. This created redundancy in compliance processes and increased the risk of audit failures or data integrity issues.
The lack of harmonization made it challenging to roll out global best practices or create a unified quality management system, resulting in high operational overhead and approval delays.
#3. Manual manufacturing transfers slowed business agility
Cross-site production transfers required redundant documentation, multi-system training validation, and dual entry across JDE instances. The lack of standardization and automation extended transfer timelines and introduced the risk of data loss, scheduling conflicts, and rework.
These delays hindered the company’s ability to respond quickly to supply chain needs or shift capacity across plants.
#4. Disparate systems diluted innovation and business alignment
The coexistence of siloed ERP systems, local automation tools, and site-specific extensions created inconsistent business processes and reporting structures.
Launching enterprise-wide digital initiatives or leveraging analytics for decision-making was difficult. This also limited the IT function’s ability to standardize platforms for new capabilities such as MES integration, mobility, or real-time orchestration across functions.
The Solution
To address the above challenges caused by ERP fragmentation, Birlasoft led a multi-year digital transformation anchored on a global JD Edwards (JDE) EnterpriseOne 9.2 consolidation program.
The engagement was structured as a phased, site-wise rollout built on a repeatable blueprint for discovery, design, data transformation, and deployment. Birlasoft combined deep ERP expertise with targeted interventions for regulatory compliance alignment, data governance, and structured change management. This ensured minimal disruption, strong user adoption, and regulatory readiness at every program phase.
1. Phased ERP consolidation built on a global transformation blueprint
Birlasoft performed a detailed discovery effort to baseline the current state across geographies, systems, and business units to map redundancies, compliance overlaps, and integration constraints.
This informed the phased rollout, which began with a core site and was gradually extended across five plants. Legacy JDE instances were rationalized into a single 9.2 environment, with archival of over 12 years of inactive data using ARCTOOLS.
This enabled centralized control, standardized reporting, and reduced IT overhead across the landscape.
2. Fit-gap led process harmonization tailored to site maturity and risk
We applied a structured fit-gap analysis framework to assess site readiness, risks, and business criticality. Workshops surfaced gaps in process compliance, master data alignment, and SOPs.
Birlasoft designed tailored playbooks for each facility, mapping global process templates to local operational needs while enforcing FDA validation requirements. The result was a scalable model that maintained regulatory integrity while supporting necessary operational flexibility at each plant.
3. Enterprise-wide data transformation backed by rigorous governance
Data quality and consistency were central to the transformation. Birlasoft activated a master data governance structure involving business stakeholders and IT custodians.
Data from legacy JDE environments was profiled, cleansed, and transformed using multiple mock cutovers with dollar-value reconciliation. Data conversion rules ensured alignment across key domains like items, suppliers, routing, BOMs, and costing.
This enabled clean financial closures and smooth operational cutovers. Robust tie-out audits validated accuracy at each stage before production go-lives.
4. Change management program aligned to compliance and adoption goals
Recognizing the high regulatory stakes and diverse user profiles, Birlasoft deployed a structured Organizational Change Management program.
This program entailed compliance sign-offs, town halls, kiosk-based self-learning modules, live simulations, and go-live readiness dashboards. The team conducted Day-In-the-Life scenarios and pulse checks to assess end-user preparedness.
This disciplined approach not only drove strong adoption but also ensured FDA audit-readiness from the first go-live, with zero findings during validation.
Impact delivered
Through this engagement, the client was able to realize the most strategic outcomes of ERP consolidation:
- Unified five plants on a single JDE 9.2 platform with minimal disruption, completing phased cutovers and achieving full operational recovery within 2–3 days.
- Ensured accurate, audit-ready data conversions, supported by multiple mock runs, dollar-value tie-outs, and governance controls.
- Accelerated and standardized manufacturing transfers through harmonized SOPs, centralized training, and integrated compliance workflows.
- Improved global process visibility and KPI alignment, reducing helpdesk volume and enabling faster decision-making.
- Established a scalable transformation blueprint for future ERP rollouts across the enterprise.
- Achieved zero compliance findings post go-live, validating the strength of FDA-aligned protocols and readiness planning.
With a unified ERP foundation now in place, the client is well-positioned to scale operations, accelerate innovation, and drive continuous improvement across its global facilities.
Looking to future-proof your enterprise with ERP consolidation? Get in touch with Birlasoft to begin your transformation.
