1. Define your integration project
Enter the project details first. You can customize the starter integrations or replace them with the systems and data flows used at your facility.
2. Integration register
Review each interface. Specify the direction of data exchange, key data, integration method, accountable owner, risk, status, and required test evidence.
| ID | Source system | Target system | Data direction | Data exchanged | Integration method | Owner | Risk | Status | Required test evidence | Notes / dependencies | Action |
|---|
3. Generate and export
Generate a plan to review interface coverage, identify missing information, and create implementation actions. You can then export the register or plan.
Integration planning report
Integration coverage review
These are planning prompts, not a determination of regulatory compliance. Confirm applicability with your quality, regulatory, manufacturing, and IT teams.
Items requiring attention
Resolve or formally assess these issues before approving the integration design.
Recommended implementation work plan
Use these steps as a starting point and assign accountable owners and due dates in your controlled project tracking system.
Interface register summary
| ID | Interface | Data flow | Method | Risk | Status |
|---|
Important limitations
- This tool creates a planning aid; it does not validate software or integrations.
- It does not determine whether 21 CFR Part 11, EU GMP Annex 11, EU MDR, or other requirements apply to a particular use case.
- CSV exports are working documents, not automatically approved or controlled records.
- Define and execute documented testing, traceability, change control, access control, backup and recovery, and release approval activities as applicable to the system and intended use.
- Final decisions and evidence should be reviewed and approved under your organization's quality management system.
How to plan eDHR and ERP integration
An electronic Device History Record system may exchange information with ERP, Manufacturing Execution Systems (MES), Quality Management Systems (QMS), inventory applications, document management systems, identity providers, and reporting platforms. A successful integration plan identifies not only what data moves, but also which system owns it, when it moves, how failures are handled, and how the interface will be tested.
1. Establish systems of record
Identify the authoritative source for work orders, material master data, lot status, routing, approved instructions, quality dispositions, and production completion. Define how updates and corrections are reconciled when systems disagree.
2. Define each interface and its data contract
Document the source, target, direction, trigger, fields, identifiers, data formats, validation rules, frequency, acknowledgements, and expected behavior when messages fail. Include interface versions and change ownership where relevant.
3. Assess data integrity and failure handling
Consider missing, duplicated, delayed, out-of-order, incomplete, or incorrect transactions. Define reconciliation, retry, alerting, auditability, and recovery procedures. Ensure that an integration failure cannot silently produce an incorrect or misleading manufacturing record.
4. Plan risk-based testing
Test expected behavior, boundary conditions, rejected messages, network failures, duplicate transactions, unauthorized access, version changes, and recovery. Maintain traceability between requirements, risks, test cases, results, and deviations according to your validation approach.
5. Prepare for deployment and ongoing support
Agree on monitoring, support ownership, escalation routes, rollback arrangements, interface configuration control, access reviews, backup and recovery, and periodic review activities before go-live.
Integration planning checklist
- Every interface has a documented business purpose and accountable owner.
- Data direction and system-of-record decisions are explicit.
- Critical identifiers and mapping rules are defined and reviewed.
- Error handling, duplicate prevention, and reconciliation are addressed.
- Security, user access, and relevant electronic record controls are assessed.
- Requirements, risks, test evidence, and approval responsibilities are linked.
- Go-live criteria, monitoring, and ongoing change control are defined.
Regulatory references and applicability should be confirmed against current official requirements and your organization's quality and regulatory assessment. This page is general planning information, not legal or regulatory advice.