Life sciences ERP selection with controlled records and clear system ownership.
Life sciences ERP connects purchasing, inventory, manufacturing costs, research spending, and financial reporting across pharma, biotech, and medical device organizations. Lightbridge ERP evaluates those systems without vendor incentives. Selection defines regulated-record boundaries, lot genealogy, validation responsibilities, and quality-system interfaces before a platform becomes part of the controlled operating environment.
Lightbridge ERP scopes life sciences systems around intended use.
A precommercial biotech, pharmaceutical manufacturer, and medical device company do not need identical ERP designs. Lightbridge ERP starts with products, development stage, manufacturing responsibility, and intended system use. A research organization may need study commitments and cash forecasting first. A commercial operation may need production genealogy, release status, and distribution controls from the first transaction.
The ERP is not automatically the quality management system. The QMS can own deviations, corrective actions, and quality decisions, while laboratory and manufacturing execution systems retain detailed test or production records. Selection must define which approved status reaches inventory and who can change it. A quality hold that arrives after goods ship is an integration failure with operational consequences.
Lightbridge ERP brings finance, quality, manufacturing, and IT into the same requirements process. Vendors demonstrate representative batches and research projects, including failed interfaces and controlled corrections. Evaluation carries no vendor kickbacks. See the ERP selection method and the platform landscape for how candidates are assessed.
Lightbridge ERP asks life sciences vendors for testable evidence.
Life sciences selection should establish what the product can do and what the organization must validate. Lightbridge ERP uses these six decision areas to separate demonstrated controls from unsupported compliance claims. Each scenario should identify the system owner, evidence retained, and acceptance authority.
| Decision area | Selection question | Evidence to request |
|---|---|---|
| Part 11 records and signatures | Which required records and approvals will be electronic, and how are identity, access, and signature meaning controlled? | A scoped record inventory and demonstration of authorization, signature linkage, and retrievable record copies. |
| Lot and batch genealogy | Can the organization trace ingredients or components through production, rework, packaging, and every shipment? | A genealogy exercise covering a split batch, supplier lot, subcontract operation, and affected customers. |
| Computer system validation | How will intended use, risk, configuration, interfaces, and changes be covered by the validation approach? | A validation responsibility matrix, sample requirements-to-test traceability, and release-change assessment. |
| Quality-system boundary | Which application owns specifications, deviations, quality approval, and the release or rejection of inventory? | A QMS-to-ERP release scenario with a rejected lot, interface failure, and controlled status reconciliation. |
| R&D and clinical accounting | Can finance distinguish programs, studies, phases, sites, and external research commitments from commercial product costs? | A study-cost report including purchase commitments, accrued services, prepaid amounts, and entity coding. |
| Regulatory audit trail | Can reviewers reconstruct who changed a controlled record, what changed, and when, through its retention period? | An audit-trail review, controlled correction, record export, and migration reconciliation using representative data. |
Lightbridge ERP defines Part 11 scope before scoring platforms.
FDA 21 CFR Part 11 addresses electronic records and signatures in its defined scope. The FDA scope and application guidance ties that scope to underlying record requirements and electronic use. Lightbridge ERP starts with a record inventory. Selection then examines access, signature linkage, audit history, retention, and computer system validation. A platform label alone cannot establish a compliant operating process.
GxP covers good manufacturing, laboratory, and clinical practices as applicable to the operation. Quality owners define the validation approach and required procedures. For covered prescription drugs, the Drug Supply Chain Security Act adds product-identification and tracing obligations. Test the serialization-system boundary separately from batch costing. Cold-chain products also need temperature-excursion evidence connected to inventory status and disposition.
Have quality and regulatory owners approve intended use, applicable requirements, and validation responsibilities. Device, pharmaceutical, and research processes require their own scope assessment before configuration is accepted.
Lightbridge ERP separates research spending from commercial performance.
Lightbridge ERP designs reporting across research entities, manufacturing operations, and commercial subsidiaries without forcing every view into the chart of accounts. Programs and clinical studies need their own dimensions. Test outside research commitments, services received but not invoiced, prepayments, and milestone evidence. Procurement status alone should not determine whether a research cost has been incurred.
Commercial reporting adds inventory valuation, batch yields, rejected material, and intercompany supply. Selection should show a consolidated close that preserves study spending and product margin while eliminating internal transactions. Foreign-currency purchasing and shared research allocations need documented rules. The multi-entity accounting guide and intercompany accounting guide explain the finance structure behind those scenarios.
Lightbridge ERP leads life sciences delivery through controlled change.
Lightbridge ERP retains ownership of requirements, architecture, project management, and technical leadership. On partner-delivered platforms, that includes coordinating data migration, interface testing, and the evidence needed for client quality review. Cutover planning must preserve open lots, release status, research commitments, and access controls. The client approves the system for its regulated use.
The broader practice delivers NetSuite and EPM/FP&A hands-on in-house for separate engagements. Every other ERP platform is built by vetted partners under Lightbridge leadership. Under the 100% Unbiased Guarantee, Lightbridge will not bid on or accept implementation for a client whose selection it advised. Program management and technical leadership of partner delivery continue. There are no vendor kickbacks or reseller quotas.
See ERP implementation leadership for delivery governance and the selection guarantee for the engagement rules.
Lightbridge ERP: life sciences ERP questions
What is life sciences ERP?
Life sciences ERP supports the financial and operational work around research, production, and distribution in pharma, biotech, and medical devices. It commonly covers purchasing, inventory, product costs, project accounting, and consolidated finance. Its regulated scope depends on the records and processes it handles. Clinical, laboratory, manufacturing execution, and quality applications may remain separate systems with controlled interfaces.
Does every life sciences ERP need the same Part 11 controls?
No. FDA 21 CFR Part 11 applies to electronic records and signatures within its defined scope, including required records maintained electronically under applicable FDA rules. Start with intended use and the record inventory. A finance-only process and a regulated batch-release process can have different obligations. A vendor feature list cannot establish compliance for the configured system and its operating procedures.
What is computer system validation in an ERP program?
Computer system validation, or CSV, documents that a computerized system performs as intended for its specified use. The organization defines requirements, evaluates risk, tests the relevant configuration and interfaces, resolves deviations, and approves release. Selection should establish responsibilities and available vendor evidence. The validation approach must also address updates and changes after go-live, with quality oversight suited to the regulated process.
Does the ERP replace the quality management system?
An ERP should not be assumed to replace the QMS. Define where specifications, deviations, corrective actions, and quality approvals are controlled. The ERP needs trustworthy inventory status and accounting records. A selection scenario should show how a quality hold prevents use or shipment, how authorized release reaches the ERP, and what happens when the quality interface is unavailable.
How should lot genealogy and pharmaceutical serialization be evaluated?
Trace a supplier lot through production, packaging, rework, and shipment, then trace a finished lot back to its inputs. For covered prescription drugs, include the applicable DSCSA product-identification and tracing requirements. Define the boundary with serialization and trading-partner systems. Products requiring temperature control also need a clear path from monitoring exceptions to inventory hold and authorized disposition.
Can life sciences ERP separate R&D and clinical-trial costs from commercial costs?
Yes, when program, study, project, and entity dimensions are designed for that purpose. Selection should test research purchase commitments, external research services, milestone accruals, and prepayments against approved accounting policies. Commercial product costs need a separate view of materials, conversion, quality disposition, and inventory. A clinical milestone should not automatically trigger an accounting entry without evidence of the underlying service.
How does Lightbridge ERP lead life sciences ERP delivery?
Lightbridge ERP runs selection, architecture, project management, and technical leadership without vendor kickbacks. Vetted partners execute other ERP platform builds; separate engagements can use the in-house NetSuite and EPM/FP&A practices. The 100% Unbiased Guarantee prevents Lightbridge from accepting implementation for a client whose selection it advised. Leadership of partner delivery continues, while the client retains quality approval and responsibility for regulated use.
Define your life sciences ERP scope with Lightbridge ERP.
Lightbridge ERP builds a scored selection around regulated-record boundaries, lot genealogy, quality approvals, and research accounting. Start with the processes your organization must be able to prove.