Product and material history
Link products, components, operations and measured attributes so investigations are based on a coherent record.
Regulated manufacturing
Keep the manufacturing evidence with the product.
For medical-device manufacturing, it matters who did the work, which recipe or specification applied, what measurements were recorded and whether the finished unit met the configured conditions.
Practical areas to evaluate
Controlled production
Apply configured recipe, routing, BOM and quality checks. Review how the machine interface responds to each result.
Reviewable actions
Assess role controls, electronic signatures, audit trails and disposition workflows against your internal quality procedures.
Validation still belongs to your quality organization
IntelliTrack™ provides a version-specific validation document library and coverage information. Optional AI-assisted tooling can help assemble draft IQ, OQ, PQ, FAT or SAT packages from approved library material and requirements.
Those packages are drafts. Your validation team must define the intended use, review the documents, execute the tests, investigate failures and approve the resulting evidence.
Regulatory fit is not automatic. Your implementation, electronic records, signatures, IT controls and procedures must be evaluated and validated for your intended use. Software functionality alone does not establish FDA or other regulatory compliance.
How we would assess fit
- Review the production recordDefine identities, operations, limits, approvals and retention needs.
- Map the interfacesIdentify equipment, ERP, inspection systems and authoritative data sources.
- Plan validationReview available documentation, specific test coverage, configuration and remaining gaps.
See how it fits your equipment and process.
Bring the controller, product or quality requirement you need to evaluate. We can review the workflow, interfaces and limits.