Life sciences ERP software selection - 2026 buyer’s guide (GxP‑ready)

Choosing ERP in a validated environment is different. This guide maps life sciences ERP selection to GxP realities—master data controls, audit trails, e‑signatures, and supplier oversight—so buyers can shortlist vendors with CSV and 21 CFR Part 11 fit from the start.

What “GxP‑ready” really means (beyond a checkbox)

In life sciences, ERP life sciences decisions live or die on controls. At minimum, the platform and its partner must support:

• Document control with status governance (Draft → Reviewed → Approved → Effective → Superseded), periodic review rules, and controlled visibility before the effective date.

• Independent audit trails (who/what/when), printable audit reports, and time‑stamped events that can’t be altered.

• 21 CFR Part 11 e‑signatures with full manifestation on output (printed name, date/time, meaning of the signature) and re‑authentication on sign; lockout and password controls.

• Supplier oversight—ability to manage a qualified‑vendor approval/release process inside ERP/EDMS.

• Lot/serial traceability and regulated inventory (shelf‑life/expiry, quarantine/MRB, COA output, sampling and non‑conformance flows). See the Quality Control Manager and Warehouse Manager requirement sets for representative controls.

• Training management tied to role and SOPs, with reminders/expiry—ideally integrated with LMS/LIMS.

If a vendor claims “we’re Part 11 compliant,” ask them to show these behaviors with your SOP language and your sample records.

Core selection criteria for life sciences erp software

Use criteria you can test in a scripted demo. Here’s a buyer’s set drawn from observing real URS/BRD patterns and understanding what auditors expect.

1. Quality & compliance (must‑have)

   • Electronic records/signatures, signature manifestation on printouts, enforced re‑auth.

   • Role‑based visibility for in‑progress vs. effective documents; periodic review workflows.

   • Lot/batch controls with quarantine, sampling, test results, and COA generation; failed‑test routing to MRB.

2. Master data & manufacturing realities

   • Formulas/BOM and bulk‑to‑fill/pack flows; shelf‑life/expiry on items; controlled substitutions via change control.

   • QC release gates in the process; barcode data capture at production/warehouse.

3. Commercial & distribution (when you scale)

   • Serialization/lot control in WMS, mobile scanning, multi‑warehouse, EDI/CRM banking hooks.

   • Chargebacks/rebates with indirect customer hierarchies, class‑of‑trade pricing, and WAC vs. indirect price logic (common for specialty/biopharma).

4. Governance & validation (CSV)

   • Requirements traceability, risk‑based testing, and the ability to validate the configuration, not just the software. Your URS should mark which requirements are subject to validation and flow into test cases.

The weighted scorecard (use this in 2026)

Lock weights before demos. Score 1–5; multiply by weight.

Criterion	Weight
GxP controls (21 CFR Part 11, audit trail, document lifecycle)	18
Lot/serial, QC & warehouse (quarantine, sampling, COA, expiry)	14
Manufacturing fit (formulas, bulk‑to‑pack, release gates)	12
Data & integrations (LIMS/LMS/EDMS, EDI/CRM/bank, APIs, error handling)	12
Reporting & evidence (printouts with signature manifestation, audit logs)	8
Security & SOD	6
Implementation partner depth in ERP medical devices / pharma	10
TCO (licenses, services, iPaaS, run‑state)	10
Roadmap & upgrade posture	6
References (same size/phase)	4

Tip: map each “Y/Validated” requirement in your URS to a scorecard row so CSV scope is visible to everyone.

Scripted demo scenarios (make vendors prove it)

1. Document control & e‑signatures

   • Create → route → sign → render to PDF with signature table → effective date future‑dating → periodic review task. Show audit trail and status transitions.

2. Quality gate on production receipt

   • Bulk batch completed → quarantine → sampling plan → pass/fail → COA → release to stock; print labels; show non‑conformance path.

3. Lot/expiry fulfillment in WMS

   • Pick by FEFO with handhelds; block expired; stage and ship; prove lot genealogy on a printed report.

4. Commercial pricing with indirects

   • Apply class‑of‑trade pricing and chargeback setup; post invoice; inspect accruals and audit reports.

5. Supplier qualification

   • Move a vendor through qualification to released; restrict purchasing until released; show approvals and history.

     
     

Your RFP content outline (short and testable)

• URS extract - Validated vs. non‑validated scope; training records; LIMS/LMS/EDMS touchpoints.

• CSV plan - V‑model, trace matrix, and Part 11 test cases for ER/ES and audit trails.

• Commercials - PRICEFW (Portals, Reports, Interfaces, Enhancements, Conversions, Forms, Workflows) and mock conversions.

• Operations - Lot/expiry, quarantine, sampling, label/print controls, mobile flows.

• Commercial - Chargebacks/rebates, indirect hierarchies.

Keep it to things you will witness in a demo or accept as artifacts.

Integration map (what life sciences actually uses)

• EDMS/QMS for SOPs, change control, and training records (signature manifestation required on printouts).

• LIMS/LMS for test results/training data; CRM and banking/lockbox for commercial ops; EDI for customers and 3PLs.

  
  

Red flags (walk away or reset)

• “Part 11 compliant” but no signature manifestation on printed output.

• No quarantine/sampling workflow or COA printout.

• Chargebacks handled off‑system in spreadsheets.

• Mobile/WMS is a future add‑on with no lot/serial story.

  
  

Timeline you can run in 3–4 months

1. Weeks 1–4: URS extract & scorecard; scripted demo packs; data/volume brief.

2. Weeks 5-7: Vendor response period and shortlisting.

3. Weeks 8–10: Scripted demos with your records; collect audit logs/printouts.

4. Week 11-12: TCO + SOW clarity (PRICEFW; mock conversions; validation deliverables).

5. Week 13: References and decision. Optional pilot on the riskiest flow.

Where “ERP for life science” differs from other industries

You’re not just picking an ERP—you’re choosing how your teams will prove control to regulators and customers every day. That’s why life sciences ERP software must demonstrate e‑signature manifestation, immutable audit trails, role‑based access, lot/expiry controls, and supplier qualification in the demo, not a slide.

If you want a clean start, I’m happy to share a ready‑to‑use scorecard, demo scripts, and a CSV checklist tailored to ERP medical devices and biopharma. Whether you run the process yourself or want facilitation, the goal is the same: a defensible decision that stands up in audits and on go‑live day.

Appendix - Sample shortlist questions you can paste into your RFP

• Show a signed document with printed name, date/time, and meaning of signature on the PDF output. Provide the audit trail report used to verify it.

• Demonstrate quarantine → sampling → COA → release for a finished batch, including a failed test route.

• Configure indirect customer hierarchy and class‑of‑trade pricing; post a chargeback and show reconciliation evidence.

• Run a FEFO pick with a handheld for serialized/lot‑controlled stock; block expired lots.

• Show training assignments and expirations tied to SOPs, and how those records appear in an audit.

Summary - This guide covers erp life sciences decisions for pharma, biotech, and erp medical devices teams—how to compare life sciences erp software for 21 CFR Part 11, Annex 11, GxP, CSV, audit trails, e‑signatures, lot/expiry traceability, COA, QA release, and LIMS/QMS/EDMS integrations. Use it to shortlist during a life science ERP software selection, to evaluate systems with the right controls from day one.