Industries · Life Sciences

ERP built for regulated life sciences operators.

GxP, 21 CFR Part 11, DSCSA, and EU MDR for medical devices, pharmaceuticals, biotech, and CROs. We deliver JDE AppCare managed services for publicly-traded life sciences operators and NetSuite for emerging companies who have to validate every change. See the case study below for a published reference.

Read the case study →

Why Now

Four forces are re-timing every life sciences operator's ERP decision.

If you're not prioritizing a platform conversation in 2026, these forces will make it for you.

Technology
April 2025
JDE World extended support ended

If you're on World, you're running unsupported. Validation documentation from a decade ago doesn't cover patches you can't install. Your options are an E1 upgrade, an R98403 replatform, or a NetSuite migration.

Regulatory
DSCSA
Serialization enforcement active

Drug Supply Chain Security Act enforcement is live across the pharmaceutical supply chain. Serialization, transaction history, and suspect product handling all have to be system-of-record.

Regulatory
EU MDR
Transition periods expiring

EU Medical Device Regulation transition periods are expiring across device classes. UDI management, post-market surveillance, and notified body documentation all have to hold up to Competent Authority review.

Market
AI
Clinical and trial data pressure

Sponsors and CRO clients want AI-augmented insights from clinical and trial data. Operators without a governed data platform are losing mandates to competitors who invested earlier.

What We Do

Core services for life sciences operators.

JD Edwards
JDE for pharma & devices

JDE Manufacturing, Quality, Advanced Planning, and Warehouse configured for GxP environments. Lot traceability, serialization for DSCSA, validated change control, and 21 CFR Part 11 compliant electronic records. See the case study below for a published reference.

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NetSuite
NetSuite for emerging life sciences

For medical device startups, emerging pharma, and biotech operators. NetSuite with serialization, lot management, and revenue recognition. Delivered on the NetSuite SuiteSuccess for Life Sciences industry edition, with GSI's DREAM methodology producing validation documentation as part of the engagement, not a separate project.

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Managed Services
AppCare & SuiteCare

Senior consultants on JDE (AppCare) or NetSuite (SuiteCare) who treat your validated environment like their own. You get a dedicated team that understands change control, validation, and FDA audit requirements. instead of a help desk queue rotating tickets through whoever is on shift.

Learn about managed services →
Integrated
Cybersecurity + Validation

vCISO, SIEM monitoring, and cloud hosting built into your ERP scope. We don't refer this out. Critical for life sciences operators handling IP, clinical data, and FDA-regulated systems where a breach can trigger warning letters.

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Industry Challenges

Challenges every life sciences operator is dealing with.

Sixteen challenges, four buckets, organized around how life sciences buyers think about their work. Click through to see what each one costs and how GSI solves it.

01
Lot traceability for DSCSA is manual and fragile.
02
Cold chain monitoring runs in a separate system.
03
Multi-site manufacturing with disconnected quality systems.
04
Serialization reporting eats weeks every quarter.
DSCSA enforcement active
"Lot traceability for DSCSA is manual and fragile. One bad serial number and the whole batch is suspect."

The Drug Supply Chain Security Act requires serialized product tracking through the pharmaceutical supply chain. Manual serialization breaks under volume, and audit findings for incomplete traceability are contract-ending events.

How GSI Solves This · JDE or NetSuite
JDE or NetSuite with DSCSA-compliant serialization, lot traceability, and supply chain visibility from raw material through patient. Audit-ready by design.
"Cold chain monitoring runs in a separate system from our ERP."

Temperature excursions for biologics, vaccines, and temperature-sensitive drugs can render entire batches unusable. When cold chain data lives outside the ERP, variance investigation takes days and costs the batch.

How GSI Solves This · JD Edwards
JDE Orchestrator integrated with cold chain monitoring systems. Temperature data flows to batch records, automated quarantine on excursion, audit trail complete.
"Multi-site manufacturing with disconnected quality systems means every new facility is a validation project."

Each manufacturing site with its own QMS means repeated validation, duplicated SOPs, and audit findings that compound. Harmonization is usually deferred until an FDA Form 483 forces it.

How GSI Solves This · JD Edwards
JDE Quality Management with multi-site harmonization, shared master data, unified change control, and consolidated batch records across all facilities.
"Serialization reporting to FDA and state agencies eats weeks every quarter."

DSCSA reporting, state-level pedigree requirements, and international serialization (EU FMD) each demand different data formats. Manual compilation is a full-time job in itself.

How GSI Solves This · JD Edwards
JDE with automated serialization reporting for FDA DSCSA, EU FMD, and state-level agencies. Reports get scheduled and submitted, not assembled.
01
21 CFR Part 11 validation documentation is out of date.
02
IP and clinical data access controls are too loose.
03
GxP change control is slow and kills innovation.
04
FDA audits find paper gaps in our electronic records.
FDA audit cycle
"21 CFR Part 11 validation documentation is out of date. Our QA team is panicking."

21 CFR Part 11 requires validated electronic records and signatures with documented system controls. Out-of-date validation documentation is the most common FDA audit finding and can trigger warning letters.

How GSI Solves This · JD Edwards + Cybersecurity
JDE Part 11 compliant configuration with validation documentation refresh, electronic signature workflows, audit trails, and IQ/OQ/PQ protocols. Validation stays current.
IP exposure active
"IP and clinical data access controls are too loose. Research staff can see things they shouldn't."

Life sciences IP, pre-clinical data, and trial results are high-value targets for IP theft and insider risk. Loose access controls on formulations, batch records, and clinical datasets are where IP leaks.

How GSI Solves This · Cybersecurity + JDE

JDE role-based access aligned to data classification, automated access logging, and integration with SIEM for insider threat detection. Research IP gets segmented from general operations.

"GxP change control is so slow it kills innovation. Every change takes 6 weeks."

GxP change control processes that take weeks for every system change stall continuous improvement. The compliance discipline that keeps you audit-ready can also keep you behind competitors.

How GSI Solves This · JD Edwards

JDE change control workflows with risk-based validation (RBV), automated impact assessment, and parallel track approvals. Compliance stays intact, velocity increases.

Paper-to-electronic gap
"FDA audits find paper gaps in our electronic records. We thought we were compliant."

Hybrid paper-plus-electronic systems create gaps where data lives in one format but is expected in another. FDA investigators specifically look for these handoffs because they're where evidence goes missing.

How GSI Solves This · JD Edwards
End-to-end electronic batch records (eBR) in JDE, eliminating paper handoffs. Single source of truth for audit, complete electronic signature chain.
01
JDE World extended support ended. Validation is getting expensive.
02
LIMS and ERP don't talk. QC data gets re-keyed.
03
15 years of validated custom code and nobody remembers why.
04
Validated environments break when patches come through.
Support ended April 2025
"JDE World extended support ended. Validation is getting expensive and risky."

Validated World environments running unsupported become increasingly expensive to maintain. Every patch, every integration, every new hire adds validation burden.

How GSI Solves This · JDE or NetSuite
Three-path assessment that compares E1 upgrade, R98403 iSeries-to-SQL replatform, and NetSuite migration. Validation approach documented for each path.
"LIMS and ERP don't talk. QC data gets re-keyed and errors compound."

Laboratory Information Management Systems and ERPs operating in silos create re-keying overhead and transcription errors. In regulated environments, every transcription is an audit finding waiting to happen.

How GSI Solves This · JD Edwards
JDE Orchestrator with LabWare, LabVantage, STARLIMS, and other LIMS integration. QC results flow to batch records automatically, no re-keying.
"15 years of validated custom code and nobody remembers why any of it exists."

Validated custom code in regulated environments carries documented justification, but institutional memory fades. When you can't explain why a custom routine exists, you can't responsibly modify or remove it.

How GSI Solves This · KinectIQ
GENOME AI for JDE custom code modernization with validation-compliant documentation generation. Converts legacy code to Orchestrations with full audit trail.
"Validated environments break when patches come through. We defer patches, then get out of support."

Patch management in validated environments requires impact assessment, regression testing, and documentation. Deferring patches creates security exposure; applying them breaks validation.

How GSI Solves This · JD Edwards
JDE patch management with automated impact assessment, pre-validated patch bundles, and streamlined regression testing. Stay patched, stay validated.
01
PE sponsor wants Day-5 close. We're at Day 20 with validation gates.
02
Just acquired a device maker. Two quality systems, two BOMs.
03
Expanding to Europe. CE marking and EU MDR are new territory.
04
Clinical trial data is everywhere. Sponsors want insights, not spreadsheets.
"PE sponsor wants Day-5 close. We're at Day 20 because of validation gates."

Validated environments require multi-step reviews that extend close cycles. PE sponsors expect financial close on the same timeline as unregulated companies, which isn't realistic without process redesign.

How GSI Solves This · JDE or NetSuite

Close acceleration in validated environments. Automated consolidation, pre-validated reports, continuous monitoring that replaces point-in-time reviews. Day-5 close achieved without validation compromise.

M&A integration
"Just acquired a device maker. Two quality systems, two BOMs, two validation histories."

M&A in regulated HLS operations has validation implications beyond standard integration. Every system harmonization decision affects FDA and EU MDR standing.

How GSI Solves This · JDE or NetSuite
M&A integration methodology for regulated environments. Validation gap analysis, phased quality system harmonization, regulatory filing alignment, and continuous GxP compliance.
EU MDR ongoing
"Expanding to Europe. CE marking and EU MDR are new territory."

EU Medical Device Regulation introduces classification changes, notified body reviews, and post-market surveillance requirements distinct from FDA. Operators new to EU MDR often underestimate the documentation lift.

How GSI Solves This · JD Edwards
JDE configuration for EU MDR requirements: UDI management, post-market surveillance, CE marking documentation, and notified body interaction. Integrated with US regulatory data.
Sponsor demand
"Clinical trial data is everywhere. Sponsors want AI-augmented insights, not spreadsheets."

Clinical trial sponsors and pharma partners expect operators to deliver AI-augmented insights on trial data. Operators without a governed data and AI platform are losing CRO mandates.

How GSI Solves This · KinectIQ
KinectIQ platform with governed data integration from CTMS, EDC, and safety systems. AI-augmented insights delivered with documented validation and audit trail.
Quick Answers

Common questions about GSI life sciences consulting.

The short version. For regulatory detail, case study depth, or differentiation, keep reading below.

What does GSI do for life sciences operators?

We build and run the validated ERP environments life sciences operators rely on. JDE Manufacturing, Quality, and Serialization for pharma and devices; NetSuite for emerging life sciences operators; and 21 CFR Part 11 electronic records compliance.

What types of life sciences operators do you work with?

Medical device manufacturers, pharmaceutical companies, biotech, CROs, consumer health, and animal health. Typically mid-market up through publicly-traded operators. See the case study below for a published reference.

JDE or NetSuite for my operation?

Depends on scale, regulatory posture, and operational profile. JDE fits publicly-traded pharma, large device makers, and multi-site manufacturers. NetSuite fits emerging pharma, device startups, and biotech. We deliver both with validation documentation produced as part of the engagement.

Can GSI handle 21 CFR Part 11 and GxP validation?

Yes. JDE and NetSuite configured for Part 11 electronic records, validated change control, IQ/OQ/PQ protocols, and FDA audit readiness. Validation isn't bolted on afterward; it's built into how we implement.

What about DSCSA serialization?

Yes. JDE and NetSuite with DSCSA-compliant serialization, transaction history, and supply chain visibility. Integration with serialization platforms (Antares, TraceLink, rfxcel) and direct FDA reporting workflows.

What makes GSI different for life sciences?

Three things worth knowing. We run JDE for publicly-traded life sciences operators and have a published AppCare managed services reference (see the case study below). Cybersecurity, AI, and validation work all run on the same bench rather than being referred out. And our consultants average 15 years in the industries they serve.

FDA 21 CFR Part 11 (Electronic Records)

Validated electronic records and signatures. System controls, audit trails, and IQ/OQ/PQ validation protocols required for FDA-regulated operations.
Audit cycle active

GxP (GMP/GLP/GCP)

Good Manufacturing, Laboratory, and Clinical Practices. Change control, deviation management, batch records, and documentation requirements.
Daily operations

DSCSA (Drug Supply Chain)

Drug Supply Chain Security Act serialization and traceability. Product identification, transaction history, and suspicious product handling.
Enforcement active

EU MDR (Medical Devices)

European Medical Device Regulation. UDI, post-market surveillance, notified body requirements, and clinical evaluation.
Transition ongoing

FSMA (Food & Food-Adjacent)

FDA Food Safety Modernization Act, particularly FSMA 204 traceability rule for human and animal food. Key Data Elements and Critical Tracking Events.
FSMA 204 enforcement

SOX (Public HLS)

Internal controls over financial reporting for publicly-traded HLS firms. Segregation of duties, audit trails, GAAP compliance.
Enforcement active

OSHA (Workplace Safety)

Incident logging, recordkeeping, safety training records, and hazard communication. OSHA 300/300A/301 reporting is built into operations.
Daily operations
Case Study

Alcon: JDE AppCare managed services at a global eye care and ophthalmic device leader.

Medical DevicesJD EdwardsLife Sciences
Published Oracle reference at one of the largest ophthalmic device and eye care manufacturers.

Alcon (independent since 2019, formerly a Novartis division) operates as a global leader in eye care and ophthalmic medical devices. GSI runs JDE AppCare managed services for the company, supporting validation documentation, GxP-compliant change control, and integrated quality management that holds up under FDA scrutiny.

 

Global
Operations Footprint
JDE
Manufacturing & Quality
GxP
Validated Environment
Read Full Case Study →
"

GSI understood GxP and validation discipline before we walked into the first meeting. They weren't learning life sciences on our project; they'd configured JDE for regulated operators like ours before.

Operations Leadership
Alcon, Ophthalmic Medical Devices
The GSI Difference

Six practices, one bench.

Established life sciences operators run on JDE; emerging companies run on NetSuite. The decision doesn't stop at the module though. Validation, compliance, cybersecurity, and AI all get delivered from the same bench, with no referrals out and no offshore handoffs.
Primary practice

JDE and NetSuite for life sciences, delivered at validation depth

We don't just configure ERP modules. We run validated environments where change control, 21 CFR Part 11 compliance, and FDA audit readiness have to hold up every day. The hard part of life sciences ERP isn't the modules. It's delivering them inside the validation discipline without killing operational velocity.
Manufacturing · Quality · Serialization
Primary JDE modules in scope
21 CFR Part 11 · GxP · DSCSA
Compliance built into delivery
Oracle Platinum Partner with 500+ JDE projects
Practice depth
NetSuite
For emerging HLS
Medical device startups and emerging pharma on NetSuite with serialization and validation.
HubSpot
HCP & payer engagement
HubSpot CRM with JDE/NetSuite for HCP engagement, sample tracking, and field reimbursement. Via Flawless Inbound.
Cybersecurity
IP + validation
vCISO, IP protection, validated environments. all on the same bench rather than referred out.
KinectIQ
AI for regulated data
KinectIQ for governed clinical and trial data insights. Validated AI pipelines.
Delivery
North America-based
Consultants in your time zone, with no offshore handoffs during validation cycles.
Frequently Asked

The questions life sciences operators ask us most.

Yes. JDE and NetSuite configured for GxP with validation documentation, change control workflows, IQ/OQ/PQ protocols, and FDA audit readiness. Validation discipline built into how we implement, not bolted on afterward.

Yes. JDE and NetSuite with DSCSA-compliant serialization, transaction history, and supply chain visibility. Integration with serialization platforms (Antares, TraceLink, rfxcel) and direct FDA reporting workflows.

Yes. JDE configured for EU MDR with UDI management, post-market surveillance, CE marking documentation, and notified body interactions. Parallel US FDA and EU regulatory data harmonized.

Yes. JDE Orchestrator integrates with LabWare, LabVantage, STARLIMS, and other lab systems as native JDE, not middleware. QC data flows to batch records automatically, no re-keying.

Extended support ended April 2025. Our three-path assessment compares E1 upgrade, R98403 iSeries-to-SQL replatform, and NetSuite migration with validation impact documented for each path. GSI is one of the few firms that can perform R98403 Data Dictionary transformations.

Depends on validation scope. Single-site NetSuite implementations run 5 to 8 months (validation adds 1 to 2 months vs. non-regulated). Multi-site JDE implementations run 10 to 18 months. JDE World-to-E1 migrations run 8 to 14 months with validation refresh.

Start with an assessment, not a demo.

Thirty minutes with an automotive practice lead. We'll walk you through what an assessment covers, what it costs, and whether GSI is the right fit, before anyone signs anything. 

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