1. Project information
Enter the project context to identify the organization, CMO, product, and planned implementation.
2. CMO integration checklist
Set a status for each item and record evidence, owners, due dates, and actions. Review critical and high-priority items carefully.
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CMO integration readiness report
Priority items requiring attention
Review these items with responsible owners and record actions in your approved quality or project management system.
Recommended next steps
Checklist status summary
| ID | Category | Checklist item | Priority | Status | Owner | Evidence / notes |
|---|
Assessment limitations
- This report is a planning aid and does not establish regulatory compliance or supplier qualification.
- Applicability depends on product, manufacturing process, market, contractual obligations, and systems used.
- Completed items should be supported by reviewed evidence and required approvals.
- Use approved procedures for quality agreements, change control, validation, batch release, retention, and CMO oversight.
How to integrate an eDHR system with a CMO
A contract manufacturer may use its own ERP, MES, quality, inventory, and electronic record systems. Define how information is exchanged, reviewed, retained, and made available, and agree on responsibilities for the records and quality activities.
Define responsibilities before connecting systems
Agree who creates and approves manufacturing instructions, controls product and process revisions, reviews batch records, investigates deviations, and authorizes disposition or release.
Preserve material and product traceability
Link finished products or lots to relevant material lots, production steps, inspections, equipment, operators, and exceptions. Confirm identifier mapping and reconciliation between systems.
Test failures as well as successful transactions
Test rejected and duplicated messages, missing fields, invalid revisions, network interruptions, incomplete batch records, and restoration after downtime. Document expected results and resolve issues before approval.
Maintain oversight after go-live
Establish procedures for monitoring, changes, periodic review, record access, training, incident escalation, retention, and end-of-contract access.
Requirements vary by jurisdiction and product type. Confirm applicable requirements with your quality and regulatory professionals. This checklist is general planning information, not legal advice.