1. Batch and review information
Enter the identifiers that will appear in the readiness report.
2. Readiness checklist
Mark each item based on objective evidence. Use “Not applicable” only when justified under your procedures. Items marked critical require particular attention if incomplete or not verified.
3. Exceptions and review notes
Record outstanding issues, references and required follow-up before the review is finalized.
4. Batch release readiness report
Your generated report will appear below without reloading the page.
Complete the checklist and click “Generate Readiness Report” to view the summary, unresolved items and review details here.
How to use this checklist
- Enter the product, lot/batch, work order and DHR identifiers.
- Review each checklist item against actual records and approved procedures.
- Select a status and record evidence or comments for each item.
- Generate the report to identify incomplete, critical or not-reviewed items.
- Export the checklist or print the report for review in your controlled process.
- Have the designated, authorized personnel make and document the actual release decision.
Frequently asked questions
What is a batch release readiness checklist?
It is a structured review aid for checking whether required production and quality records have been completed, reviewed and reconciled before an authorized release decision. The exact checks depend on the product, process, applicable requirements and approved procedures.
What is the difference between a DHR and a batch record?
Terminology varies by organization and regulatory context. A device history record generally documents the production history of a device or defined production quantity, while “batch record” is often used for records associated with a batch or lot. Your organization should define the records required for its products and processes.
Does a high checklist score mean the batch can be released?
No. A score summarizes the answers entered; it does not establish conformity, validate evidence, resolve deviations or grant release authority. A single unresolved critical issue can require a hold even when the overall completion percentage is high.
Should non-applicable items be marked complete?
No. Record them as not applicable and document the justification where required by your procedures. This tool keeps “Not applicable” separate from “Complete” in its report.
Does this tool store my batch information?
This standalone page performs its checklist calculations in the browser and does not submit the entered information to a database. Exported files are downloaded to your device. Avoid entering confidential or regulated production information unless your organization's policies permit using this tool.
Important limitation
This checklist is a general planning and review aid, not a validated electronic quality system, electronic signature service or release authorization. It does not verify the authenticity or completeness of source records. Adapt it to your approved quality management system, product-specific controls and applicable regulatory requirements. Maintain official records in your designated controlled systems.