QPPV Agent

Illustrative sample pack

What a named QPPV can download and walk an inspector through — the shape of Path-2 artefacts, not a live MAH case and not for EDA filing.

Why this pack exists

Buyers and quality leads often ask what “export ready” and “inspectable” actually look like before a walkthrough. These fictional fixtures answer that without opening a tenant workspace. Every name, product, and identifier is illustrative.

How Path 2 works

1. Platform prepares

   Deadlines, drafts, packs, and audit events stay in the MAH workspace.

2. Named person downloads

   E2B-shaped XML, submission ZIP, registers, and pack excerpts leave as files.

3. Human files outside the app

   Signature and transmission to EDA / PVGA happen on official channels — never through AllesEra.

What is in the pack

Four artefacts plus a short README. Open a preview below, then download if you want the raw file.

• E2B(R3)-shaped XML

  Inspector asks: Show me an export-shaped case package.

  Truncated illustrative ICSR export. Values are fictional. The platform prepares the file; a human downloads and files outside the app.

  Excerpt

  <!-- ILLUSTRATIVE ONLY — not a live MAH case -->
  <id … extension="ILLUSTRATIVE-ICSR-0001"/>
  <creationTime value="20260315"/>
  … causalityAssessment displayName="Related" …

  Download file

• Audit trail sample

  Inspector asks: Show the trail from create to export and attestation.

  Append-only style events: create, workflow, export, attestation — the reconstruction path an inspector expects.

  Sample rows

  icsr.created → ILLUSTRATIVE-ICSR-0001
  icsr.workflow → medical_review
  icsr.exported → E2B R3 package downloaded
  psmf.attested → ready_to_file — platform does not submit

  Download file

• PSMF section excerpt

  Inspector asks: Show system-document evidence with the accountability boundary.

  One illustrative PSMF section stating that the named QPPV remains accountable and that software does not submit to EDA.

  Excerpt

  Named QPPV — A. Example, PharmD (fictional)
  The named QPPV remains legally accountable.
  The supporting software does not e-sign and does not transmit to EDA or PVGA.

  Download file

• Signal / ESI register

  Inspector asks: Show ESI and signal clocks on the Egyptian calendar.

  Inspection-oriented register with Cairo dates and a five-working-day ESI row — shape only, not live safety data.

  Sample rows

  ILLUSTRATIVE-ESI-0003 · esi · Day 4 of 5 Egyptian working days
  ILLUSTRATIVE-SIG-0007 · signal · assessment closed (illustrative)
  ILLUSTRATIVE-SIG-0008 · signal · medical assessment required

  Download file

Pack README

Next step

If the shape matches what your QPPV needs to demonstrate, book a walkthrough against your portfolio — or send a written RFP.