CMO360 · Life Sciences · External / Contract Manufacturing Operate

See trouble in your CMO network weeks before it becomes a failed batch.

CMO360 gives external-manufacturing leaders a live line of sight into every contract manufacturer — correlating weak early signals across safety, quality, service and cost so your team moves from firefighting to foresight, with the evidence to act before a deviation becomes a recall.

● Deployed & running in the cloudGxP-grade governance · proposes; people disposeDeploy as SaaS, any cloud, or your own cloud
The problem

You manufacture through CMOs — but you have no direct line in.

Your product is made outside your four walls, yet the signals that warn of a problem reach you only after the damage is done.

01
No live line of sightSponsors run their network through monthly business reviews, scorecards and email. By the time a number turns red, the batch is already at risk.
02
The KPIs you trust are laggingOTIF misses, OOS results and audit findings confirm trouble after it has happened — they tell you where you have already been hurt, not where you are about to be.
03
SAM field knowledge evaporatesYour Supplier Account Managers see the early tells on site — a stretched line, a stressed team, a workaround. That intelligence dies in notebooks and inboxes.
04
Concentration risk hides in plain sightA single CMO, site or sterile line can sit behind dozens of SKUs. Nobody owns the cross-portfolio view until supply is already short.
How CMO360 works

One closed loop, from weak signal to defensible action.

The same disciplined Amplinth loop, tuned to CMO risk intelligence — every confirmed signal makes the next prediction sharper.

01

Connect

Unify open- and closed-book CMOs into one model; consume SAP, Veeva, Kinaxis & TraceLink (integrate, never replace).

02

Reason

An asset & capability knowledge graph plus the SQSC signal engine fuse weak cross-domain signals into a composite CMO health score.

03

Recommend

Each ranked signal arrives with a full evidence chain — cited data points, a lead-time estimate, a named owner and a confidence band.

04

Act

The Daily Action Brief and Signal Inbox route the right play to the right owner — CMO360 proposes; qualified people dispose.

05

Prove

Lead time bought, signals confirmed and risk retired — quantified, audit-ready, and learned from.

Capabilities

~30 cockpit modules across three differentiated builds.

An asset-and-capability knowledge graph, a cross-domain signal engine and field intelligence from the people on site — fused into one composite view of network health.

Asset & Capability Knowledge Graph

A governed model of every CMO, site, line, qualification and SKU dependency — so concentration risk, recall readiness and batch genealogy are one query away, not a fire drill.

SQSC Signal Engine

Statistical models plus precision LLMs fuse cross-domain data into one composite health score — Safety, Quality, Service, Cost — and rank the leading signals behind every shift.

SAM Field Intelligence

Offline-first mobile capture lets Supplier Account Managers log voice, photo and checklist observations on site; the AI reads the language of shortcut, pressure and uncertainty.

The Cockpit (~30 modules)

Signal Inbox, Daily Action Brief, Concentration Risk, Deviations & CAPA, Recall Readiness, Cold Chain / GDP, Serialisation, Batch Genealogy, AI Model Governance and a full Audit Trail.

Consume, never replace

CMO360 sits above the systems you already run — consuming SAP, Veeva, Kinaxis and TraceLink as sources of truth. A layer, not a rebuild, so value lands in weeks with no rip-and-replace.

Evidence on every signal

No black-box score. Every ranked signal names its cited data points, its model, a lead-time estimate, a named owner and a confidence band — so a quality lead can defend the call to an auditor.

Outcomes

Deployed and running in the cloud — shifting your network left.

One composite SQSC view per CMO, one evidence chain per signal, and a single model that holds your entire external-manufacturing network.

14+ days
Lead time before an OTIF miss
· target
21+ days
Lead time before a quality event
· target
100%
Of CMOs in one data model
· target
1 view
Composite SQSC health per CMO
· target

All figures are design targets and objectives, to be validated with each customer. Company names shown anywhere in the application are demo data and do not represent any named customer.

GxP governance & how it works

Connect → Customize → Operate.

Connect CMO360 to your network and source systems — SAP, Veeva, Kinaxis, TraceLink. Customize the SQSC weights, signals and field checklists to your portfolio — the shape is reusable; the risk logic is what we tailor. Operate the closed loop in production under GxP control — GAMP 5, 21 CFR Part 11, EU Annex 11 and ALCOA+ — where CMO360 proposes and qualified people dispose, and every confirmed signal sharpens the next one.

GAMP 521 CFR Part 11EU Annex 11ALCOA+Full audit trailSOC 2ISO 27001
SaaS
Amplinth SaaSFully managed — fastest path to value.
VPC
Your own cloud / VPCYour CMO data and field intelligence never leave your control.
Any cloud / regionAWS, Azure, GCP — data residency by default.
Why Amplinth

A layer, not a rebuild.

Industry-deep

Purpose-built for pharma external manufacturing — SQSC, concentration risk and recall readiness are first-class, not bolted on after the fact.

Governed & explainable

GxP-native by design: GAMP 5, 21 CFR Part 11, EU Annex 11 and ALCOA+. Every signal names its evidence, its model and its confidence — CMO360 proposes; qualified people dispose.

Additive

It sits above SAP, Veeva, Kinaxis and TraceLink — consuming what you already run, not replacing it. Value lands in weeks, with no rip-and-replace.

See CMO360 on your network

From firefighting to foresight.

The next OTIF miss or quality event should announce itself weeks ahead — as a ranked signal with a named owner, a lead-time estimate and the evidence to act. Let us show you how, on your own CMO network.