Compare the work each option requires from your organization: configuration, operating procedures, assurance, interfaces, training, and ongoing changes. Test the proposed configuration against the work your team intends to perform.
This article gives Quality, IT, and asset teams a common way to examine those responsibilities. Document the same test cases for each candidate.
TL;DR: You’ll Take Away
How to read this article: The comparison questions are practical evaluation tools. Product capabilities require evidence for the proposed version and configuration; category labels and demonstrations alone do not establish compliant operation.
Request the supplier’s available evidence and map it to the system you intend to use. Identify the proposed configuration, interfaces, procedures, and remaining verification. Ask who prepares each item and who approves its adequacy.
Supplier documentation supports your assurance work. It does not transfer accountability for fitness for intended use away from the regulated firm.
When a supplier describes a product as purpose-built, ask what that means in the proposed configuration. Which work-order fields, calibration workflows, review steps, and record-history functions are already available? Which require configuration? Which need an interface or additional development?
Record the answer with the version and configuration demonstrated. Treat demonstrated, configuration-dependent, and unresolved as evidence states. Attach each result to the specific product, configuration, and intended use.
Plan how the approved system will enter ordinary use. Confirm asset data, work instructions, user responsibilities, training, and record-retention arrangements. Ask which dependencies could delay the transition and who owns them.
A useful demonstration follows a representative asset from setup through scheduled work, execution, review, and retrieval. Document what the example actually proves. Use that evidence to identify the work still needed before rollout.
Where offline work forms part of your intended use, include it in the evaluation. Follow a test record through capture, correction, reconnection, and any conflict resolution. Examine identity, timing, record history, and signature linkage where signatures are used.
For records in Part 11 scope, evaluate the relevant controls against §§11.10(e), 11.50, and 11.70. Record the mobile behavior shown in the proposed configuration.
Ask the supplier to demonstrate the review rules your organization intends to use. Examine a proposed schedule change, a controlled workflow change, or a parts-substitution case relevant to your process. Determine who authorizes it and what evidence remains.
For EU GMP computerized systems, Annex 11 §10 addresses change and configuration management, and §11 periodic evaluation. The product demonstration should support the process you have defined.
Examine how maintenance and calibration information relates to the same asset. Can the team distinguish the recorded result, equipment status, outstanding work, and decision about use? If records reside in separate systems, demonstrate how their relationship is maintained.
Define how the approved process handles maintenance work, calibration status, and any restrictions on equipment use. Use ICH Q9(R1) to frame the risk-based assessment.
Identify the purpose of each connection and the system that owns each record. Ask how a rejected, delayed, or conflicting update is recognized and resolved. Record the supplier’s support responsibilities and your organization’s remaining work.
Part 11 §11.10(e) specifies audit-trail controls for records in scope. EU Annex 11 §9 addresses audit trails of GMP-relevant changes and deletions on a risk basis. Applied to an interface, the relevant record history must remain accountable across the handoff. Evaluate the proposed connector against the record and its intended use.
A standard connector still needs evaluation for its intended use and configuration. Assign the configuration, verification, and support work for each interface.
Use the same scope for every option. Document implementation, asset-data work, configuration, interfaces, assurance, training, support, upgrades, and any planned expansion. Distinguish a supplier commitment from an estimate or unresolved dependency.
| Cost Area | Question to Resolve |
|---|---|
| Implementation | What work is included, and what remains with your team? |
| Assurance | Which evidence is supplied, and what remains to be assessed or produced? |
| Interfaces | What must be configured, tested, supported, and changed over time? |
| Ongoing use | Who maintains procedures, training, permissions, and master data? |
| Releases and expansion | What responsibilities repeat, and which assumptions need rechecking? |
Use measured local costs where available. Where you estimate, record the owner and test how the estimate changes the decision. Make the assumptions and remaining work visible before choosing.
Bring the demonstrated workflows, remaining work, responsibilities, and cost assumptions into one decision. Ask what would need to be true for each option to meet your intended use. Keep unresolved questions visible until the accountable owner answers them.
If your evaluation includes Maximo support and migration decisions, continue to the Maximo End of Support guide. For the broader evaluation, use the Compliance Feature Checklist.
Updated September 2026 to clarify evaluation questions, evidence, and lifecycle responsibilities.
