What a 1000+ person contract manufacturer should look for in an operating system.

A small CMO can run on a mid-market ERP plus a spreadsheet stack and survive. A large CMO cannot. At a thousand people you typically operate three or more production sites, a hundred plus active brand customers, several thousand SKUs and a regulatory footprint that touches every major market. Every weakness in the system compounds across that surface area.

The cost of getting this wrong is not licence fees. It is the COO spending Monday mornings reconciling three sites' production numbers, the regulatory team rebuilding the same customer declaration twelve times for twelve customers, and the lab data sitting in a LIMS that does not talk to the batch record. The price of the wrong system is paid in operating margin, not in software invoices.

1. Multi-site, multi-entity at the core. Not as a configuration. The system should treat sites and legal entities as first-class objects, with shared masters, local stock and a real consolidation layer for finance. If the demo opens one entity at a time, that is the future of your month-end close.

2. Customer-specific workflows. Each brand client has its own approval matrix, label requirements, COA template, EDI dialect and changeover expectations. The platform must let you model that variation per customer without forking the codebase. Ask to see three live customer workflows in the same demo.

3. Lot and batch genealogy. Full backward genealogy (which raw material lots went into this finished good batch) and full forward genealogy (which customers received product made with this raw material lot). This is the recall question, and the system should answer it in seconds, not days.

4. Regulatory depth. A CMO's regulatory burden is the union of every customer's regulatory burden. The system needs native EU 1223/2009, UK Cosmetics, MoCRA, EU REACH, UK REACH, CLP, GHS, Prop 65, PPWR and the Asian regimes for the customers shipping there. Generic ERPs cannot fake this.

5. AI that drafts the regulatory and customer paperwork. The volume of customer declarations, COAs, allergen statements, vegan attestations, palm-oil statements and changeover packs at a 1000-person CMO is the single biggest source of regulatory headcount. AI that drafts the document for human approval is the largest productivity unlock available in this category.

6. MES, LIMS, WMS and EDI integration. The operating system is the ring, but the production floor runs on the MES, the lab runs on the LIMS, the warehouse runs on the WMS, and the customers communicate via EDI. Ask for the connectors in production today, with named customers, not the marketing list.

7. Twelve months to live, not five years. The industry norm for a large CMO ERP programme is three to five years. Modern platforms can compress this to twelve to eighteen months with a phased rollout. If the vendor wants longer, you are paying for their professional-services business, not their product.

8. Vendor survival. You are buying a ten-year relationship. Ask about ownership, runway, the last three acquisitions in the category, the roadmap and what happens if the vendor is bought. The wrong answer here is the most expensive answer.

• "Show me one finished-good batch with its full backward genealogy to raw material lots and its forward genealogy to every customer shipment, on one screen, live."
• "Show me how customer A's COA template, customer B's customer declaration and customer C's allergen statement are all generated from the same batch record, with no manual rekeying."
• "What is the consolidated gross margin by customer, by site, by SKU, for last month? Show me the path the system took to compute it."
• "When the SVHC candidate list updates, what changes in this system without anyone touching it, and which customer declarations does it flag?"
• "Walk me through your last three implementations at sites of our size. Who led them? Can I speak to them this week?"
• "What is the named MES, LIMS, WMS and EDI partner you have in production with a customer doing more than 100 million GBP of revenue?"

The vendor that answers these with live software and named references is in a different bracket from the one that opens a slide deck. Both will be in your shortlist. Only one belongs in your contract.

A realistic five-year all-in cost for a 1000-person CMO programme sits between five and fifteen million GBP depending on the legacy stack being replaced. The split is roughly: licence 25%, implementation 35%, integration 20%, internal team 15%, change management 5%. Vendors that lead with the licence number are quietly betting that the other 75% will arrive after the contract is signed. The cheapest licence is rarely the cheapest programme.