CDMO ERP selection - 12 must‑have capabilities for 2026

Contract developers and manufacturers don’t run like standard discrete shops. You live in make‑to‑order, often with client‑owned materials, regulated quality, and an audit trail that must satisfy customers and regulators. The right CDMO ERP must reflect that reality on day one, before scope creep, “Phase 2,” or a validation scramble.

Drawing on anonymized URS/RFI/FRD sets and scorecards from multiple CRO/CDMO and med‑device engagements, here are the 12 capabilities we require vendors to prove in 2026, plus exactly what to ask them to demo and document.

1. End‑to‑end batch/lot genealogy (with retained samples)

   • Why it matters - Auditors and clients will ask you to show where every gram came from and where it went.

   • Require - Full lot genealogy (inbound → WIP → finished goods), retained‑sample tracking with location, pull dates, and test history.

   • Ask vendors to demo - Receive a raw lot; auto‑generate a sampling plan; quarantine → release; consume to batch; show one‑click genealogy from finished lot back to every input, retaining sample details.

2. Specifications, potency & expiry (COA/CoC out of the box)

   • Why it matters - Specs aren’t notes; they drive acceptance, calculations, and expiry.

   • Require - Target potency with min/max ranges, shelf‑life/expiry at item or lot level, and COA generation at release and shipment.

   • Ask vendors to demo - Enter potency on batch completion and watch yield, potency‑adjusted quantity, and expiry cascade to COA.

3. QC planning, sampling & LIMS/instrument hand‑off

   • Why it matters - Manual triggers and spreadsheet lab records break data integrity.

   • Require - Item/lot rules to auto‑trigger QC, destructive/non‑destructive sampling, and integration patterns for LIMS and instruments (e.g., HPLC/GC) with result attachment and status control.

   • Ask vendors to demo - Auto‑send lots “to test,” capture results (even if just attached), and block release until pass.

4. Non‑conformance & MRB with true quarantine

   • Why it matters - “Quarantine” labels without system enforcement are audit bait.

   • Require - System‑enforced status locations (Quarantine/Rejected/Released), MRB workflows, labeled segregation, and disposition logging.

   • Ask vendors to demo - Fail a lot, trigger NC → MRB → disposition, and prove stock can’t ship while quarantined.

5. Client‑owned materials (chain of custody & billing uplifts)

   • Why it matters - Many CDMOs convert the client’s material on your line; you must track custody and bill fairly.

   • Require - Separate ownership flags, custody history, and automated handling/processing fees on pass‑through items (percentage or fixed).

   • Ask vendors to demo - Receive as client‑owned; convert; invoice with uplift lines generated automatically.

6. EBR/eDHR‑ready shop‑floor data capture

   • Why it matters - Paper travelers won’t scale; auditors want who/what/when tied to each step.

   • Require - Barcoded issuance/returns, labor & machine time capture, and controlled step sign‑offs with e‑signatures/audit trails.

   • Ask vendors to demo - Start/stop machine & labor on a batch; capture a deviation; require a supervisor e‑sig before continuing.

7. Stability studies & environmental monitoring (EM)

   • Why it matters - Trending, pulls, and excursions are central to many programs.

   • Require - Stability protocols (pull schedules, storage conditions), EM capture (rooms/equipment), and trend charts with alerting.

   • Ask vendors to demo - Create a stability study tied to a finished lot; schedule pulls; record temperature excursions with impact assessment.

8. Equipment calibration & maintenance—with process gating

   • Why it matters - Uncalibrated equipment = invalid lots.

   • Require - Calibration/PM schedules, certificate storage, and the ability to block production if calibration is overdue.

   • Ask vendors to demo - Attempt to start a batch on an overdue scale; show the hard stop and how to document a calibration to proceed.

9. Controlled labeling & artwork; UDI/GS1 where applicable

   • Why it matters - Printing outside control breaks traceability and labeling regulations.

   • Require - Controlled print with revisioned templates, role‐based access, and UDI/GS1 support (if device/combination product).

   • Ask vendors to demo - Change a label version; restrict printing by role; serialize/aggregate if needed.

10. Client segmentation, entities & revenue models

    • Why it matters - CDMOs need to see margins by client, program, molecule, and sometimes by clinical vs. commercial business.

    • Require - Dimensions for client/program, multi‑entity consolidations, and flexible billing (T&M, milestone, per‑batch/test, pass‑throughs).

    • Ask vendors to demo - Run two invoices: one milestone, one T&M + pass‑through lab fees; show margin by client/program.

11. Supplier qualification, incoming QC & AVL

    • Why it matters - Qualification and Approved Vendor Lists drive release and risk.

    • Require - Supplier status, COA verification on receipt, third‑party lab flows, and AVL controls at item level.

    • Ask vendors to demo - Receive from an unqualified supplier and watch the system enforce hold until approval.

12. Validation package, Part 11 & audit readiness by design

    • Why it matters - Validation cost and time balloon when you start from zero.

    • Require - Part 11 e‑signatures & audit trails, vendor validation accelerators (pre‑built test scripts, record/playback, traceability matrices), release cadence, and change‑impact documentation.

    • Ask vendors to provide - Example IQ/OQ/PQ scripts, an e‑signature configuration guide, and a regression test plan tied to upgrades.

What to put in your scorecard (and how to weight it)

We weight by business risk and validation impact, then force vendors to answer each requirement with a simple key: 1 = out‑of‑box, 2 = light customization, 3 = native ISV, 4 = heavy custom, U = unknown.

Typical weight set (tune to your risk)

• GxP & Data Integrity (Part 11, audit trail, e‑sig) - 15–20%

• QC/LIMS & Batch Genealogy - 15–20%

• Client Model & Billing (client‑owned material, uplifts, milestones) - 10–15%

• Stability/EM & Equipment Gating - 10–12%

• EBR/eDHR Shop‑floor Capture - 10–12%

• Labeling/UDI & Shipping Docs - 8–10%

• Finance (entities, dimensions, revenue recognition) - 8–10%

• Supplier Qualification/AVL - 5–8%

• Implementation & Validation Accelerators - 8–10%

Vendors then get scripted demos using your data to prove the risky bits (e.g., client‑owned receipt → sampling → batch → COA bundle → milestone invoice). We merge RFP responses, demo scores, services estimates, and five‑year TCO into one steering‑ready heatmap.

Validation & audit tips that save months

• Traceability from demo to PQ - Reuse demo scripts as test scripts; map each to URS IDs so auditors see the lineage.

• Lock roles early - Define least‑privilege roles (Ops, QC, QA, Finance, IT) before UAT; it shortens Part 11 testing.

• Favour maintained connectors - For LIMS/labeling/EDI/tax, pick validated connectors to survive cloud upgrades.

• Bundle the ship docs - COA/CoC, BOL, temperature logs, client‑specific certificates—assemble as a single, versioned packet at ship confirmation.

• Plan hyper‑care - Four weeks of post‑go‑live support with QA present is normal in regulated go‑lives.

  
  

How we can help with CDMO ERP selection

We bring CDMO‑specific URS libraries, demo scripts, and weighted scorecards so vendors can’t paper over gaps during your CDMO ERP selection. If you want a vendor‑neutral short list, or just a sanity check on your current one, we’ll share anonymized models and a validation‑friendly plan (roles, scripts, and change control) you can use immediately.