Readiness · 2 weeks

ISO 17025 / GMP Readiness Score

100-point AI-driven readiness scorecard against ISO 17025 (testing labs) or 21 CFR Part 211 / EudraLex Vol 4 (GMP). Plus a 90-day prioritized remediation plan with an AI-monitored progress tracker.

Price

From $500

scoped per document volume

SLA

2 weeks

end-to-end turnaround

For

Labs / CROs / CMOs

accreditation or surveillance

What's Included

  • 100-Point Scorecard

    Every ISO 17025:2017 clause (or every Part 211 / Annex 1 section, depending on standard) scored 0–100 with evidence cited from your documents.

  • Gap Heatmap (Visual)

    Color-coded gap heatmap by clause family — instantly see where you're audit-ready and where you're exposed.

  • 90-Day Remediation Plan

    Prioritized actions with owners, deadlines, acceptance criteria, and the specific evidence each one needs to produce.

  • AI-Monitored Progress Tracker

    Optional add-on: connect your remediation tracker (Notion / Asana / monday) and our AI watches progress, flags slipping items, and re-scores monthly.

  • Pre-Audit Tabletop

    Optional add-on: 90-minute mock interview with your QA + technical staff before the assessor arrives.

  • Decision-Grade Evidence Pack

    Every finding linked back to its source document section. AI outputs use QGI's replayable / signable / defensible framework.

2-Week Engagement Flow

  1. Week 1, Day 1–2 Kickoff + secure document upload + AI ingestion
  2. Week 1, Day 3–5 AI scoring across all clauses + senior-consultant calibration
  3. Week 2, Day 6–8 Drafting scorecard, heatmap, and 90-day plan
  4. Week 2, Day 9–10 Sign-off call + handoff + (optional) tracker setup

Reserve your readiness assessment

Tell us your standard (ISO 17025 / 21 CFR Part 211 / EudraLex Annex 1) and document volume. We'll scope within 24 hours.

Reserve a Discovery Call →