AI that survives a GxP audit.

The question that kills every life-sciences AI pilot is "can we validate it?" SphereIQ answers it — every response cited, every action ledgered, deployed in a validated GxP environment.

Get the GxP AI Validation Checklist Read the customer stories

Can AI be used in GxP environments?

Yes — when governance is enforced in the request path. SphereIQ has been deployed in validated GxP environments, with validation documentation packs (IQ/OQ/PQ support), audit-grade ledgers, human-approval workflows, and citation-verified answers that quality teams can trace to controlled source documents.

Deployed where the compliance bar is highest.

A life-sciences services firm runs a SphereIQ knowledge assistant in a GxP context — controlled documents in, cited answers out, every interaction ledgered. If it clears life-sciences quality review, your industry's bar is already met.

GxP ✓

Deployed in a validated environment at a life-sciences services firm

100%

Of answers cited to controlled source documents

Ledgered

Every query and answer, audit-exportable on demand

Same platform. Pre-built for your world.

Vertical editions ship with a pre-built Twin schema, agent templates, and compliance packs for the industry — so deployment starts at mile ten, not mile zero.

Pre-built

GxP validation pack

IQ/OQ/PQ support documentation, intended-use definitions, and audit ledger exports mapped to your quality system.

Agent templates

Manufacturing & quality agents

SOP assistant, deviation support, batch-record Q&A, and training-compliance agents — grounded in controlled documents only.

Twin schema

Life-sciences Twin

Pre-modeled entities: sites, suites, equipment, SOPs, roles, and the approval chains that connect them.

The GxP AI Validation Checklist

The two-page checklist our team uses to scope validated AI deployments: intended use, data controls, audit evidence, and the questions your quality team will ask — answered before they ask them.

Send me the checklist

Asked in every evaluation

Does using AI mean revalidating our quality system?

No — SphereIQ deploys as a defined, validated system with its own documentation pack, scoped to intended use. Your existing controlled processes remain the source of truth; the platform adds governed access to them.

Can it run fully inside our environment?

Yes. The SphereIQ Private deployment model runs in your cloud with your keys — a common choice for GxP and clinical-adjacent workloads.

What about 21 CFR Part 11?

Electronic-record integrity is native to the architecture: immutable ledgers, attributable actions, timestamped approvals, and exportable evidence.

Your competitors are waiting for permission. The permission structure now exists.

Start with a scoped, validated pilot on one controlled-document collection.

Talk to the vertical team Start with a Twin Scan