Checklist

Audit Readiness Checklist — Quality, Safety & Regulatory

Interactive pre-audit checklist to evaluate documentation, traceability, training, CAPAs, and physical readiness. Capture status, evidence, owners, and next steps so teams can prioritize corrective actions before customer or regulator audits.

Interactive Tool

Audit Readiness Checklist — Quality, Safety & Regulatory

Use this checklist to evaluate and capture evidence for audit readiness across key areas. For each item, select the status, add evidence (file path, document ID, photo reference), assign an owner, and set a due date or priority for remediation if needed. Saved submissions create a simple record teams can review and act on before an external or customer audit.

Evidence examples: SOP number and storage location, training matrix export, BOM/lot trace report ID, CAPA closure record, and a photo of controlled areas.

Are current SOPs and controlled documents available, at the correct revision, and accessible to auditors?
Provide file names, document IDs, or a link to the document control system.
Person responsible for producing the documents.
Can you demonstrate traceability from finished goods to raw materials and lot/serial history?
List reports, batch numbers, or system paths that demonstrate traceability.
Are training matrices, competency records, and signed training forms up to date for audited roles?
Provide the training matrix export file name, or location of records.
Are CAPAs documented, with root cause analysis and evidence of containment/closure where required?
Are manufacturing areas clean, labeled, and do control plans and inspection records show compliance?
Summarize quick actions, who to notify, and any blocking issues.
You can explore this tool now. Sign in or create an account to save your responses and return to them later.
Sign In to Save Create an Account
Make this tool part of your work

Save a personal copy, bring it to your team, or tailor the questions and workflow to fit what you are hungry to improve.

Member customization and team collaboration are coming soon.
Discuss Ask the Librarian

Discussion

Comments and conversation will live here.