Getting started

Getting started with the portal

Sign in, find your way around the portal, understand what the AI does and what people decide, and learn the pattern every record follows.

In the portal: /app

Signing in

  1. Step 1: Go to the portal and sign in with your organization account. An administrator invites you by email; the invitation is valid for 7 days.
  2. Step 2: Your access level (User, Administrator or Super administrator) is shown on your profile and on the Security and audit page.
  3. Step 3: You are signed out after 15 minutes without activity. Unsaved typing is lost, so save as you go.

Tip: Electronic signatures always ask for your sign-in email and password again, even when you are signed in. See Records, review and signatures.

The products

ProductUse it toChapter
Q IntelligenceAsk about any record, document or regulation; draft the next record; chart and analyse dataQ Intelligence
Q Agent and Agent runnerHand off multi-step work; run scheduled reports; get alertsQ Agent, Agent runner
Complaint handlingTriage complaints and start investigationsComplaints
InvestigationsRoot cause analysis, hypothesis tests, CAPA planInvestigations
Batch record reviewReview executed batch records by exceptionBatch record review
Signal detectionFind shifts and trends in resultsSignal detection
Agentic QMSChange control, CAPA, controlled documents, work queueAgentic QMS
ValidationPlan, execute and document validationValidation
Regulatory submissionsScreen changes for regulatory impact and draft sectionsSubmissions
Backlog triageRank open records by riskBacklog triage
Q Dashboard and Generated chartsSee the QMS at a glance; trend dataDashboard, Control charts
Regulatory librarySearch FDA, ICH, EU GMP, EMA and PIC/S with page citationsRegulatory library
Security and auditIntegrity check, access levels, security eventsSecurity and audit

What the AI does, and what people decide

  • The AI drafts: triage, analyses, assessments, plans, sections and charts, with exact quotes from the write-up ("W") or attached documents (D1, D2…).
  • People decide: every disposition, decision, priority and route is chosen by a person, with a reason when it changes a value.
  • People sign: only people submit, review and approve, with an electronic signature.
  • Everything is recorded: each AI draft, edit, decision and signature is an entry in the hash-chained audit trail, with the AI tool and model named.

Rule: The AI never signs, closes, releases a batch or decides reportability. Drafts it proposes in Q Intelligence do not exist until a person creates them.

The pattern every record follows

Record life cycle
  1. Person

    1. Create

    Text, attachments, reference; a number is assigned

  2. AI drafts

    2. AI draft

    With quoted evidence

  3. Person

    3. Decide and edit

    Reasons for changes

  4. System

    4. Readiness check

    Lists what blocks submission

  5. E-signature

    5. Submit for review

    Author signs: Authored

  6. E-signature

    6. Review

    Sign as reviewed or return

  7. E-signature

    7. Approve

    Approve and sign or reject

  8. System

    8. Signed and locked

    Exports stamped APPROVED

  • Returned or rejected → back to draft; everyone signs again in the next cycle.
  • Needs a change after signing → an administrator reopens it with a reason.
  • Opened in error → cancel it with a justification; it keeps its number and audit trail.

Every record page has the same side panels: readiness, Review and approval, Connected records, documents, a note, Export, Ask Q Intelligence, the audit-trail integrity badge and the audit trail itself.

Your first day

  1. Step 1: Open Reviews and approvals (the bell in the header) to see what is waiting for your signature.
  2. Step 2: Open the Work queue to see every open record across products, what each is waiting for and who owns it.
  3. Step 3: Set your working profile (role, site, products, markets) so Q Intelligence answers in your context, and your alert emails.
  4. Step 4: Ask Q Intelligence "What needs my attention today?".
  5. Step 5: To practise, an administrator can load the Demo workspace.