Quality operations for GxP teams

Audit and CAPA, connected from plan to closure.

Quorvane helps GxP service providers and suppliers replace manual, paper-based audit and CAPA processes with connected, reviewable workflows.

Request a walkthrough Explore the Hubs

Audit preparation · findings · signatures · CAPA follow-through

Six connected workspaces

A Hub for each part of quality work.

Each Hub keeps its work focused while records and follow-through stay connected.

Audit Prep

Prepare risk-based plans, checklists, and document requests.

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Risk Assessment

Record risks, controls, reviews, and decisions.

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Vendor Audits

Carry supplier audits from preparation through findings and follow-up.

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CAPA Management

Track corrective actions, owners, due dates, and closure.

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Inspection Readiness

Coordinate inspection preparation, checklists, and findings.

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Hosted Inspections

Run hosted inspection work in a dedicated workspace.

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The Hubs open in the authenticated Quorvane workspace.

A connected record

Keep the evidence with the decision.

Move from preparation through review and corrective action without losing the context between checklists, findings, approvals, and follow-up.

  1. STEP 01

    Prepare

    Set the scope, plan the work, and organize the checklist and requests.

  2. STEP 02

    Capture

    Keep observations and supporting evidence connected to the record.

  3. STEP 03

    Review

    Make decisions with attributable history and workflow sign-off.

  4. STEP 04

    Close

    Carry findings into CAPA ownership, due dates, and follow-up.

Service offers

Start with the quality work in front of you.

Explore focused support for supplier audits, risk management, and regulatory inspections.

Supplier audit detailsRisk management detailsInspection service details

Emerging service line

AI quality and compliance, grounded in pharmaceutical quality.

Alongside Quorvane's established pharmaceutical quality work, this emerging service line focuses on AI governance, AI workflow assessments, and quality controls for AI-assisted documentation.

Its perspective draws on the founder's pharmaceutical quality experience and Agentic AI Engineering training.

Discuss AI quality and compliance

Areas of focus

  • AI governance

    Governance considerations for AI use in quality-related work.

  • AI workflow assessments

    Assessments of workflows that include AI, viewed in their quality context.

  • Quality controls for AI-assisted documentation

    Considerations for quality review of documentation prepared with AI assistance.

Reviewability by design

Trust comes from a record you can review.

Quorvane keeps sign-off and record history close to the quality workflow, with a careful distinction between design intent and regulatory claims.

Electronic signatures

Electronic signatures attach to workflow records; each entry shows the signer, meaning, and timestamp.

Record audit trails

Review documented, attributable record history alongside the decisions and work it supports.

Part 11-style rigor

Designed with 21 CFR Part 11-style rigor as a design reference—not a claim of certification, validation, or guaranteed compliance.

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See how the workflow fits your quality process.

Tell us whether supplier audits, inspection readiness, risk assessment, or the emerging AI quality service line is your priority. We'll use that context to focus the conversation.