Joseph Dasari
Kirankumar Bollineni / August 26, 2025 / 4 minutes of readingERP for Life Sciences
Driving Compliance and Innovation in a Regulated Industry
In today’s era of precision medicine, accelerated drug development, and global operations, life sciences companies face intensifying pressure from regulatory scrutiny, operational complexity, and rising costs. At the same time, many organizations are planning for IPO or preparing to operate under public company standards—where compliance expectations are even higher.
Enterprise Resource Planning (ERP) systems have become essential to managing this complexity. When implemented with a life sciences and compliance-first mindset, ERP enables organizations to meet FDA, EMA, and Sarbanes-Oxley (SOX) requirements while improving efficiency, enabling innovation, and supporting financial transparency.
Why ERP, and Why Now
Recent regulatory shifts—from evolving GxP guidance to increased scrutiny of digital systems have elevated the urgency for integrated, auditable platforms. At the same time, global events like COVID-19, serialization mandates, and supply chain instability have exposed the risks of fragmented systems and manual processes.
ERP platforms provide a centralized, validated digital backbone that connects operations across R&D, manufacturing, quality, regulatory, finance, and supply chain. For IPO-bound or publicly traded companies, ERP also supports SOX compliance through strong internal controls, access governance, and audit-ready processes.
ERP in the Life Sciences Context
An ERP system tailored for life sciences delivers key benefits that extend beyond basic integration:
- Regulatory compliance: Built-in GxP controls, 21 CFR Part 11 validation, audit trails, and electronic signatures
- Product lifecycle visibility: Seamless transitions from clinical development to commercialization
- Financial control: Real-time revenue recognition, cost tracking, and global tax compliance
- Global supply chain integration: Inventory management, serialization, temperature control, and materials traceability
- SOX compliance: Segregation of duties, access control, automated financial workflows, and complete audit logging—critical for public company reporting and internal control frameworks
- Quality integration: Deviation tracking, CAPA workflows, and batch-level traceability
Execution: Implementing ERP with Compliance in Mind
A successful ERP implementation is more than a technology upgrade—it is a cross-functional initiative with long-term compliance and business continuity implications. Key execution steps include:
- Assess readiness: Evaluate system maturity, regulatory risks, and SOX control gaps
- Define a roadmap: Engage stakeholders from Quality, Regulatory, Finance, IT, and Audit from the outset
- Choose the right platform: Select right-sized ERP systems suited for life sciences, such as Oracle NetSuite, QuickBooks, or Acumatica—each offering robust compliance features, scalability, and integration capabilities
- Build for validation and auditability: Align with FDA/EMA Computer System Validation (CSV) guidance and SOX 404 audit requirements
- Enable adoption through training: Align SOPs, change control processes, and role-based access policies
- Establish governance: Maintain long-term compliance through defined ownership, risk monitoring, and continuous improvement
How Celito Supports ERP Transformation
Celito brings proven experience delivering ERP programs that align with life sciences compliance and business needs from day one. Our approach includes:
- GxP-aligned delivery: Accelerators and pre-validated templates that meet regulatory expectations while speeding time to value
- End-to-end ERP services: Support across system selection, validation planning, implementation, go-live, and post-implementation inspection readiness
- SOX readiness: Expertise in aligning ERP controls to internal audit standards, including financial reporting accuracy, change management, and segregation of duties
- Domain expertise: Deep understanding of finance, accounting, FP&A, procurement, and global supply chain operations—ensuring that ERP implementations support real-world execution, not just compliance
What Sets Celito Apart
Unlike generic ERP vendors, Celito offers a compliance-first transformation model designed specifically for life sciences. We integrate ERP with adjacent systems—such as HR, MES, FPA, Expense systems, Benefits providers, and Supplier portals—to create a connected, transparent, and audit-ready digital ecosystem.
Our clients benefit from systems that not only meet today’s compliance requirements but are also structured to scale—whether expanding product lines, entering new markets, or preparing for IPO.
Conclusion
ERP is no longer optional for life sciences companies. It is a strategic foundation for regulatory compliance, operational agility, and investor confidence. As the industry faces mounting scrutiny—from FDA inspections to SOX audits—companies need ERP partners who understand both the science and the business of life sciences.
Celito delivers ERP implementations that are compliant, scalable, and aligned with the unique needs of public and growth-stage organizations. Whether you are optimizing for inspection readiness, expanding globally, or preparing for IPO, Celito helps you build with confidence.