Define the capabilities your electronic Device History Record software must support. Select requirements and generate a structured specification for your project team and vendor evaluations.
1. Project profile
Enter your project information. Everything is processed in your browser; this tool does not submit the form to the server.
2. Select requirements
Recommended requirements are preselected. Adjust the selection to match your intended use and project scope.
0 selected
Core eDHR Functionality
Quality Management and Approvals
Electronic Records, Signatures, and Audit Trails
Integrations and Data Exchange
Reporting and Performance
Validation, Security, and Continuity
Your requirements specification is ready
eDHR Software Project
0Total requirements
0Critical priority
0High priority
0Categories covered
Project profile
Project notes
Detailed requirements
Before approving this specification:
Confirm applicable electronic record and electronic signature requirements, including 21 CFR Part 11 where relevant.
Define measurable acceptance criteria for each applicable requirement.
Link requirements to risk assessments, verification tests, results, and deviations.
Review integrations, security, backup, record retention, and change control.
Have qualified quality and regulatory personnel review and approve the final requirements.
This generated document is a planning aid, not proof of regulatory compliance.
How to build an eDHR requirements specification
Define the intended use
Identify product families, manufacturing operations, record types, users, sites, interfaces, and system boundaries.
Make requirements testable
Specify expected behavior, conditions, permissions, exceptions, and acceptance criteria. Avoid broad statements without defining what the system must do.
Assess regulatory applicability
Evaluate applicable requirements for your products and markets. Regulatory applicability should be determined by qualified personnel rather than assumed to be identical for every implementation.
Use the output in vendor demonstrations
Ask suppliers to demonstrate each applicable requirement and document whether it is supported natively, requires configuration, needs custom development, or depends on another system.