GxP AI

COMPLIANCE STUDIO

GxP AI

COMPLIANCE STUDIO

GxP AI

COMPLIANCE STUDIO

AI-Powered URS Generation

We turn structured interviews into audit-ready User Requirements Specifications, grounded in your GxP standards and generated in minutes, not weeks.

Get started now

What we offer

Structured requirements interview

Automated URS drafting

Regulatory context retrieval (RAG)

GxP-compliant formatting

Version-controlled outputs

Audit trail logging

PDF/Word delivery

URS generation built for audit, not just speed

Writing a User Requirements Specification manually means hours of interviews, cross-referencing SOPs, and reconciling formatting against internal templates, all before a single review cycle begins. Our pipeline replaces that process with an AI agent trained on your GxP standards, so every requirement is captured, grounded, and audit-ready from the first draft.

Structured requirements capture: A guided AI interview extracts system requirements directly from stakeholders, mapped to GxP-compliant fields.

RAG-grounded accuracy: Every generated requirement is retrieved against your approved standards, including 21 CFR Part 11, EU Annex 11, ICH Q9, and GAMP 5, before drafting.

Audit-ready by default: Outputs follow your organization's URS template, with version control and traceability built into every document.

Scalable across document types: Start with URS. Expand to FRS, DQ, IQ, OQ, PQ, and deviation reports.

Interview & Intake

Conduct a structured AI interview to extract system requirements directly from stakeholders and map them to GxP-compliant URS fields.

Interview & Intake

Conduct a structured AI interview to extract system requirements directly from stakeholders and map them to GxP-compliant URS fields.

Draft Generation

Automatically populate your URS template with retrieved regulatory context, eliminating blank-page effort and formatting inconsistency.

Draft Generation

Automatically populate your URS template with retrieved regulatory context, eliminating blank-page effort and formatting inconsistency.

Compliance Check

Cross-reference generated requirements against 21 CFR Part 11, Annex 11, and your internal SOPs to flag gaps before submission.

Compliance Check

Cross-reference generated requirements against 21 CFR Part 11, Annex 11, and your internal SOPs to flag gaps before submission.

Delivery & Handoff

Export the finalized URS as an audit-ready PDF or Word file, with version metadata and approval routing intact.

Delivery & Handoff

Export the finalized URS as an audit-ready PDF or Word file, with version metadata and approval routing intact.

Flexible plans for GxP-ready teams

Pay-As-You-Go

Best for a client testing the product on a single project or one-off validation need.

$349

/month

Get started

Guided interview session, RAG-grounded document generation, one rendered deliverable, one revision round

Standard email support, 3-business-day response

No subscription, no minimum, no infrastructure commitment

Starter plan

Built to support small QA teams or solo consultants generating URS documents on a recurring basis.

$999

/month

Get started

Everything in Pay-As-You-Go, plus:

Up to 5 URS documents/month

Single workspace on shared multi-tenant infrastructure

Email support, 2-business-day SLA

Enterprise plan

Built for mid-size life sciences consultancies or internal validation teams with recurring document volume.

$2999

/month

Get started

Everything in Starter, plus:

Up to 20 URS documents/month

Dedicated Qdrant collection for client data isolation

Priority support via Slack, 1-business-day SLA

Quarterly regulatory content refresh included

Pay-As-You-Go

Best for a client testing the product on a single project or one-off validation need.

$349

/month

Get started

Guided interview session, RAG-grounded document generation, one rendered deliverable, one revision round

Standard email support, 3-business-day response

No subscription, no minimum, no infrastructure commitment

Starter plan

Built to support small QA teams or solo consultants generating URS documents on a recurring basis.

$999

/month

Get started

Everything in Pay-As-You-Go, plus:

Up to 5 URS documents/month

Single workspace on shared multi-tenant infrastructure

Email support, 2-business-day SLA

Enterprise plan

Built for mid-size life sciences consultancies or internal validation teams with recurring document volume.

$2999

/month

Get started

Everything in Starter, plus:

Up to 20 URS documents/month

Dedicated Qdrant collection for client data isolation

Priority support via Slack, 1-business-day SLA

Quarterly regulatory content refresh included

Pay-As-You-Go

Best for a client testing the product on a single project or one-off validation need.

$349

/month

Get started

Guided interview session, RAG-grounded document generation, one rendered deliverable, one revision round

Standard email support, 3-business-day response

No subscription, no minimum, no infrastructure commitment

Starter plan

Built to support small QA teams or solo consultants generating URS documents on a recurring basis.

$999

/month

Get started

Everything in Pay-As-You-Go, plus:

Up to 5 URS documents/month

Single workspace on shared multi-tenant infrastructure

Email support, 2-business-day SLA

Enterprise plan

Built for mid-size life sciences consultancies or internal validation teams with recurring document volume.

$2999

/month

Get started

Everything in Starter, plus:

Up to 20 URS documents/month

Dedicated Qdrant collection for client data isolation

Priority support via Slack, 1-business-day SLA

Quarterly regulatory content refresh included

FREE RESOURCE

Download a GxP-ready URS template built for validation teams

Structured for compliance

Our URS template follows GAMP 5 and 21 CFR Part 11 conventions, with pre-built sections for system overview, functional requirements, regulatory constraints, and traceability mapping.

Structured for compliance

Our URS template follows GAMP 5 and 21 CFR Part 11 conventions, with pre-built sections for system overview, functional requirements, regulatory constraints, and traceability mapping.

Ready to populate

Every field includes inline guidance notes so your team knows exactly what regulators and auditors expect no blank-page paralysis, no missing sections.

Ready to populate

Every field includes inline guidance notes so your team knows exactly what regulators and auditors expect no blank-page paralysis, no missing sections.

Compatible with our automation workflow

The template is the same format used by our AI-powered URS generation workflow. Start manually, then automate when you're ready to scale.

Compatible with our automation workflow

The template is the same format used by our AI-powered URS generation workflow. Start manually, then automate when you're ready to scale.

Download free URS template

FAQs

Clearing doubts about our URS generation

What is AI-powered URS generation?

How does the system stay compliant with GxP standards?

Can the workflow be customized to our internal templates and SOPs?

What document types can this workflow support beyond URS?

Can this handle large-scale or multi-system documentation needs?

Where does our data go, and how is it secured?

What is AI-powered URS generation?

How does the system stay compliant with GxP standards?

Can the workflow be customized to our internal templates and SOPs?

What document types can this workflow support beyond URS?

Can this handle large-scale or multi-system documentation needs?

Where does our data go, and how is it secured?