Platform Deployment for Pharmaceuticals

Pharma cannot run regulated work on unvalidated, externally hosted AI. GxP, FDA expectations, and validated-system requirements mean any tool touching pharmacovigilance, regulatory submissions, or evidence synthesis must be installed, qualified, and documented in an environment you control. A black-box SaaS API has no installation qualification, no change control, and no audit trail a regulator will accept. Platform Deployment installs our products and your AI stack inside your own validated cloud, with IQ/OQ/PQ documentation, change control, and full traceability built into the deployment itself. The system becomes part of your validated estate, defensible in an FDA inspection rather than a liability waiting to be questioned.

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How we deliver it

Platform Deployment, built for pharmaceuticals

We deploy into your validated cloud environment with infrastructure-as-code, producing installation and operational qualification evidence as part of delivery.

We bring the platform under your change control and SOP framework, so updates are versioned, reviewed, and documented to GxP expectations.

We build traceability and audit logging for every model action, supporting 21 CFR Part 11 expectations on records and signatures.

We hand over qualification documentation and environment ownership so your QA and validation teams can maintain qualified state.

Where it pays off in pharmaceuticals

Pharmacovigilance intake

Triage and code adverse event reports inside a validated environment, with full traceability for safety review.

Regulatory submission support

Draft and check submission documents against your templates and standards without content leaving your controlled estate.

Evidence synthesis

Run literature and study synthesis on validated infrastructure, with sources and reasoning logged for review.

Validated document QC

Apply AI quality checks to GxP documents inside change control, keeping every action auditable.

Validation and QA teams bring AI into qualified state in a fraction of the usual timeline, because qualification evidence and change control are produced during deployment rather than bolted on after.

Pharmaceuticals AI, answered

Yes, when it is deployed and qualified properly. We install into your validated environment and generate IQ, OQ, and PQ evidence as part of delivery, then bring it under your change control. It enters your validated estate like any other GxP system.

We build the records and audit trail to support Part 11 expectations: traceable actions, controlled access, and where applicable, electronic signatures. Because it runs in your environment, your QA team owns the evidence and can present it during inspection.

Updates go through your change control. We version every change, document the impact, and support requalification where needed, so the system stays in qualified state rather than drifting out of validation between releases.