Resources | Kintavo
RESOURCES

What auditors look for — and how to be ready before they ask.

Built from the same playbooks our customers run. Useful whether you choose Kintavo or not.

INTERACTIVE · 3 MINUTES Audit Readiness Assessment Eight questions. An honest readiness score, your highest-risk gaps, and what to fix first — scored the way an inspector would. Take the assessment →
FREE TOOLKIT · PDF + TEMPLATES CAPA Master Toolkit Root-cause worksheets, an effectiveness-check template, and the closure checklist our customers use.
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BUYER'S GUIDE · 5 MINUTES How to Evaluate an eQMS Nine questions to take to every vendor demo, including ours — and how to weight the answers. Read the guide → PRODUCT BRIEF · PDF Lab Quality & Inventory Brief The short platform overview built for forwarding — to your director, IT, or procurement. Download the PDF →
FIELD NOTES
AUDIT READINESS · 9 MIN The 7 Most Common FDA 483 Observations The patterns barely change year to year — which means the next 483 is preventable. Read → AUDIT READINESS · 8 MIN CAP Inspection Checklist Walkthrough How inspectors actually sample, the line items that bite, and the structural fix for each. Read → CAPA · 7 MIN How to Write a CAPA That Actually Closes Root cause past “operator error,” actions with teeth, and an effectiveness check that means something. Read → COMPLIANCE · 10 MIN 21 CFR Part 11 Requirements, Explained What the regulation actually requires — and the three questions that test any “Part 11 compliant” claim. Read → DATA INTEGRITY · 8 MIN Data Integrity and ALCOA+, Explained The audit-trail patterns that convert principles into findings, and how to stop leaking evidence. Read → VALIDATION · 8 MIN QMS Validation: What IQ/OQ/PQ Actually Requires Who owes what under GAMP 5, and why validation is weeks — not quarters — for configured systems. Read → IMPLEMENTATION · 7 MIN eQMS Implementation in 8–12 Weeks: What to Expect The realistic week-by-week path from kickoff to validated and live — and what stretches it. Read → AUDIT READINESS · 8 MIN Preparing for Your AABB Assessment How assessors pull threads, the five evidence chains that get sampled, and the 90/60/30-day plan. Read → SUPPLIER QUALITY · 7 MIN Supplier Quality Without the Spreadsheet Qualification that expires, scorecards that change behavior, and an approved list that enforces itself. Read → TRAINING · 7 MIN CLIA Competency: The Six Elements What each element requires, the first-year semiannual trap, and documentation inspectors accept. Read →

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RELATED Buyer's guide → Glossary → Readiness assessment →