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Sutra Intelligence · Life Sciences & Healthcare

The answer is in your SOPs. Finding it should not take an hour.

Sutra Intelligence is the AI layer that sits over your compliance and quality documentation. Cited answers in seconds. Contradictions caught before an inspector finds them. An audit trail that stays inspection-ready by default.

Sutra Intelligence is not a search engine for your SOPs.

It is not ChatGPT pointed at your documents. It is not keyword search with nicer UI. Sutra Intelligence understands the regulatory context of what you are asking — traces every answer back to the exact document section, flags where two SOPs say different things, and maps what changes when a guidance update lands. That distinction matters when an FDA investigator is in the room.

What Quality and Compliance teams are dealing with right now.

  • SOPs spread across hundreds of documents with no fast way to search them accurately — answers buried where teams do not have time to look.
  • Contradictions between documents that only surface when an inspector finds them.
  • Regulatory guidance updates triggering manual review cascades that take days and still miss things.
  • Institutional knowledge that lives in experienced team members' heads — and walks out the door when they leave.
  • Audit trails assembled by hand under time pressure, never quite ready when an inspection lands.

Features.

Feature 1
SOP Intelligence

Ask a compliance question, get a cited answer referencing the exact SOP section — in seconds. Your team stops spending hours searching and starts operating with confidence.

Feature 2
Contradiction Detection

Finds conflicting guidance across SOPs, regulatory documents, and internal policies before an inspection does. The specific documents, sections, and the nature of the conflict — surfaced automatically.

Feature 3
Change Impact Analysis

When an SOP or regulatory guidance changes, the system maps the downstream impact across every connected document. No more manual cascade reviews.

Feature 4
Institutional Knowledge Memory

Captures the answers, decisions, and rationale that live in experienced team members' heads — and makes them searchable, auditable, and available to everyone.

Feature 5
Regulatory Alignment Monitoring

Watches regulatory guidance for updates and flags where internal documentation is no longer aligned — before the gap becomes a finding.

Feature 6
Compliance Audit Trail

A full log of questions asked, documents referenced, answers given, and changes tracked. Structured and inspection-ready at any time.

Works with the document environment you already have.

Sutra Intelligence connects to your documentation where it already lives. No migration. No manual tagging. No rebuilding your document architecture from scratch.

  • Veeva Vault

    Quality and regulatory document management

  • SharePoint

    Internal policies, SOPs, and quality manuals

  • Confluence

    Internal knowledge bases and process documentation

  • Quality Management Systems

    Standard QMS platforms and document control systems

  • Regulatory guidance repositories

    FDA, ICH, and EMA guidance documents

Additional integrations available. Contact us to confirm compatibility with your specific environment.

See It In Action

Ask a compliance question. Get a cited answer in seconds.

Type any compliance question below or select one from the examples. Sutra Intelligence searches your connected documentation, surfaces the relevant SOP sections, and returns a cited, audit-ready answer — the way it works for your Quality and Compliance teams every day.

Example questions
Select an example or ask your own question to see Sutra Intelligence at work.

Every answer Sutra Intelligence returns is traced to the exact document and section it came from — not generated from general knowledge. The audit trail is logged automatically. When an inspector asks how a decision was made, the answer is already documented.

What inspection readiness costs without this.

Documentation and training gaps are among the most cited findings in FDA 483 observations. Most of them are findable before an inspector ever walks in. Sutra Intelligence finds them first — and keeps finding them as your documentation evolves.

Documentation and training gaps — among the most cited FDA 483 findings.
FDA
Who This Is For

Designed for the teams doing the work.

Quality and Compliance teamsRegulatory Affairs teamsManufacturing and Operations teamsMedical and Scientific Affairs teams

Frequently asked.

What types of documents can Sutra Intelligence work with?+

SOPs, regulatory guidance, internal policies, quality manuals, and any structured documentation Quality and Compliance teams rely on.

How does Contradiction Detection work?+

Sutra Intelligence maps relationships between every connected document and flags sections where guidance conflicts — pointing to the specific documents, the sections, and the nature of the conflict.

Is the Compliance Audit Trail inspection-ready?+

Yes. Every question asked, document referenced, answer given, and change tracked is logged with a timestamp and user attribution — structured for inspection review.

Can Sutra Intelligence support GMP training qualification tracking?+

Yes. It tracks employee training status against every SOP version and automatically flags gaps when documents change — preventing the training record gaps that show up as GMP observations during inspections.

Ready to see Sutra Intelligence in action?