VALIDATED AI EXECUTION FOR GXP
Your agents will be inspected.
RemoteDay is the qualified environment where AI agents work on GxP data. Versioned workflows, constrained actions, routed signatures, and an immutable Part 11 audit trail on everything the model does.
TWO WEEKS · FIXED FEE · YOU KEEP THE ASSESSMENT
Illustrative. Every action carries its full context, model version, and reviewer.
Of employees are already using AI tools their organization hasn't approved.
Of organizations have any AI governance policy in place at all.
Success rate for purely internal builds, against 67% for vendor-led delivery.
Attributable, legible, contemporaneous, original, accurate — and reconstructable.
WHY AGENTS AREN'T IN PRODUCTION YET
Your validated systems have a gap. People are filling it.
Off-the-shelf software covers most of what you need. The rest — the part specific to how your plant actually runs — gets closed by someone reconciling an export, routing an approval by email, or keeping the spreadsheet between two systems that don't speak. AI could close that gap tomorrow. In a GxP environment, three things stop it.
The same input can give a different answer
Validation means documented evidence of consistent results against a predetermined specification. A model doesn't behave that way. Until you can qualify the envelope rather than the output, QA can't sign it.
The model changes underneath you
A provider ships a new version and your validated state has silently changed. Nobody produced an impact assessment because nobody knew. That's an inspection finding waiting to be written.
A chat log is not an audit trail
Who, what, when and old-to-new value was designed for human actions. It cannot tell an inspector why a model reached a conclusion eighteen months ago. Without that, the record is unreconstructable.
HOW IT WORKS
Three phases. Each one priced on its own.
We start with the work people are doing by hand, not with a platform migration. You can stop after any phase — so you're never buying the next one to justify the last.
Workaround census
We map where people are bridging your validated systems — the exports, the email approvals, the spreadsheets between the MES and everything else. You get the top twenty ranked by hours consumed, each classified by GxP impact and priced to close. A menu you can buy from, not a report you have to decide about.
Build and validate
We compose the workflow on the platform from validated primitives, define where the agent may act and where a human must sign, and generate the qualification evidence as we build rather than reconstructing it afterward. Requirements, risk assessment, test execution and traceability come out as artifacts, not as a document project.
Run and keep it validated
Validation isn't an event. Models get revised, upstream systems get patched, processes change. The platform pins your model versions, runs the regression suite on every change, and produces the impact assessment automatically. Someone has to own the validated state in eighteen months. That's the subscription.
WHAT'S DIFFERENT
An agent platform QA can actually approve.
General-purpose agent tools hand you a blank canvas and leave compliance as your problem. Automation vendors quote the build and leave the validation tail out of the number. We ship the workflow and its evidence as one thing, because in a regulated plant they were never two things.
- [01]Constrained action surfaceAgents don't take free-form actions. They select from a bounded set of validated operations, so the operations qualify deterministically and only the selection needs statistical treatment.
- [02]Pinned models, automatic impact assessmentModel and inference versions are locked to the validated state. When one changes, the regression suite fires and a documented impact assessment is produced before anything reaches production.
- [03]Human in the loop by risk, not by defaultYou define which actions an agent may complete and which must route for signature. Low-risk steps clear automatically; anything touching a disposition decision goes to a qualified person.
- [04]Templates, not a blank canvasDeviation triage, CAPA effectiveness, review by exception, supplier assessment and change impact ship pre-built and pre-validated. Composition happens inside guardrails you can defend.
THE EVIDENCE LAYER
An inspector should be able to reconstruct the decision, not just find the log.
Part 11 audit trails were designed around human actions. An agent needs more: the context it was given, the version that produced the answer, the tools it called, and what the reviewer actually saw before signing.
- ✓Full decision context, captured immutablyThe prompt, the retrieved documents, the tool calls and their outputs, the model identity and version, and the confidence signal — recorded at the moment of the action and never edited.
- ✓Version control on everything that shapes behaviourWorkflows, agent definitions, tool sets and connected servers are all versioned and routed for approval. Nothing reaches a GxP process without a signature on the change.
- ✓Qualified connections, not open integrationsEvery connected tool server is supplier-qualified and scoped to what it is approved to do, so an agent can't quietly open an unvalidated path into a regulated record.
START HERE
Book a workshop.
Half a day with your quality and operations leads to find where people are bridging your validated systems, and which of those gaps an agent could close under signature. We'll come back with a scope, a fee and a start date — or an honest note that we're not the right fit.
- DIRECT
- hello@remoteday.com
- TYPICAL FIRST YEAR
- 3–12 validated workflows in production
Request received
We'll reply within two business days with a scope, a fee and a proposed start date. If we don't think we're the right fit, we'll tell you that instead.