FOR LABS, PLANTS AND QUALITY TEAMS
Data your auditors can follow, in your own cloud.
Monitoring data, lab apps and the AI around them, with a record you can prove, a named actor for every job, and your data in your own Azure. Built with GxP (good practice) data integrity in mind. The validation stays yours.
New to OpenX? Key terms →
ALCOA++ · WHAT OPENX PROVIDES
- Attributable
- The signed-in identity on every record
- Contemporaneous
- The server's clock, not the caller's
- Original
- Append-only writes; corrections keep the original
- Accurate
- A SHA-256 chain you can verify
- Enduring
- Retention periods that can only be extended
What OpenX provides, mapped in the docs. Limits included.
WHERE DATA INTEGRITY LIVES IN OPENX
A record you can prove, around the data you run on.
A record in your storage
Provenance writes create-only, hash-chained records to storage in your own subscription, locked as immutable in production.
Corrections with a reason
A correction keeps the original, names a reason from a set list, and can need a second person to approve it.
Signatures with their meaning
Signing names what the signature means, and you choose whether signers sign in again: once a session or for every signature.
A name for every job
A LIMS sync or a historian export gets its own identity, so what it uploads and sends names the machine actor. Records also note how each actor got in: as a team member, an app or a job.
Monitoring you can query
Cleanroom and equipment data in Azure Data Explorer, with saved queries for excursions and batch traceability.
AI that proposes
An AI connected over MCP proposes changes for a person to accept, and cannot edit the record.
IF THE QUESTION IS ALWAYS "WHO CHANGED THIS?"
For the people who answer to an auditor.
Quality and compliance leads
Show who changed what, why, and who signed, with the docs' ALCOA++ mapping as a starting point for your own validation.
Lab and manufacturing IT
Keep monitoring data, records and identities in the company's own Azure subscription and region.
Teams bringing AI into GxP work
Let AI draft queries and changes for a person to accept, while the record stays out of its reach.
NEXT TO YOUR QMS AND LIMS
Not a QMS or a LIMS. The platform beside them.
Quality suites, signing tools and lab systems do their jobs well, with their own audit trails. OpenX gives the data, apps and AI around them a record of their own, in your cloud, and can forward chosen records to the systems downstream.
- Records in your own subscription, reducing, not removing, the third-party scrutiny Annex 11 asks for.
- A compliance matrix that says what is recorded today, and what is not.
- Fathym holds no certification. Whether a workspace meets a requirement is for you and your auditor.
A WEEK IN A REGULATED WORKSPACE
From an excursion to a signed record.
A deviation, end to end
- 01A warm query finds a cleanroom excursion.
- 02A QA app you build on OpenX records a correction with a reason.
- 03A reviewer signs it, signing in again to do so.
A LIMS sync with a name
- 01A sync job gets its own identity in your directory.
- 02Your API Manager rules limit what it reaches.
- 03Its uploads name the job, not a shared account.
Batch traceability
- 01Lot records sit in a Cosmos DB container.
- 02Sensor data sits in Data Explorer.
- 03One saved query filters the readings by lot and serves the answer.
WHERE TEAMS START
Three places OpenX fits first.
MONITORING
Cleanroom and equipment monitoring, with excursion thresholds and traceability.
LAB DATA
Sample and lot records in your own region, with writes on the record.
LICENSED DATA PRODUCTS
Access to a data product for partners, granted and removed with a subscription.
Your data, your record, your validation.
Start with the compliance matrix, then see it running in your own Azure.
MORE OF OPENX
AI governance →
Over MCP, AI proposes and a person accepts. Only a person deploys.
OpenX MCP Server →
A few tools let any MCP-capable AI read your workspace and propose changes to it.
API Manager →
Your workspace is already an API. Decide who may call it and what each caller reaches.
Warm queries →
Save a question over live data and serve the answer to dashboards, apps and AI.
Provenance →
A record you can prove, kept in your own cloud, with corrections and signatures.
Your cloud →
Connect your Azure, build the landing zone, and the rest of OpenX runs inside it.
Databases →
A Cosmos DB store in your subscription, with a governed API for each container.
App Identity →
Your own sign-in directory, identities for your jobs, and access in one window.
Licenses →
Sell what you build on your own Stripe, and turn a subscription into a plan's rights.
IoT →
IoT Hub and Data Explorer in your Azure, feeding queries, APIs and AI.
Communications →
Send mail through your own relay, with the password in your vault and sends on record.
App building →
Data, sign-in, access, an API and billing: your app's backend, already there.