AI-powered data migration for regulated systems—
audit-defensible, every step.
MAiGRATE — part of CLAiRE AI Agentic Platform — automates the most complex and risky part of any platform transition: moving regulated data from legacy systems to modern platforms. Automated ingestion, intelligent mapping, data cleanup, validation, and loading — with a complete audit trail that satisfies FDA and EU GMP requirements.
Every regulated data migration carries the same risk: data arrives in the new system with integrity questions that surface during the first audit. MAiGRATE documents every decision — because 'the vendor did it' is not a defensible answer to an FDA inspector. Every transformation, every mapping decision, every cleanup action — documented, traceable, and governed under ISO/IEC 42001.
Legacy data migration is broken — and it's putting your implementations at risk.
Tribal knowledge dependency
Current migration approaches rely on institutional knowledge held by individuals who may leave. When the person who "knows the system" is gone, your migration stalls — or worse, fails an audit.
Manual, consultant-driven processes
Traditional migrations require armies of consultants manually mapping fields, cleaning data, and documenting decisions. Expensive, slow, and inconsistently documented.
No audit trail for migration decisions
When an FDA inspector asks why a field was mapped a certain way or what happened to a particular record, "the vendor did it" is not an acceptable answer. Most migration tools leave no defensible evidence trail.
Timelines measured in quarters, not weeks
Manual data migration in regulated environments routinely takes 6–18 months. Platform modernization stalls. Compliance programs stay on legacy systems far longer than planned.
What a regulated data migration looks like when every decision is documented.
Every migration decision is documented and traceable
Field mapping rationale, data cleanup decisions, validation approach — all documented in an audit trail that satisfies FDA and EU GMP data integrity requirements. Governed under ISO/IEC 42001.
Data arrives clean, mapped, and validated
Automated cleanup algorithms address messy legacy data structures — and document every transformation with CLAiRE AI Agentic Platform governance.
Migration timelines measured in weeks, not quarters
MAiGRATE's automated pipeline — ingestion, mapping, cleanup, validation, loading — compresses migration timelines dramatically versus manual approaches.
Legacy data is available and usable in the new system
Searchable, linked, and appropriately structured — not dumped as an archive. Historical compliance records support ongoing programs from day one in the new platform.
From legacy data to audit-ready modern platform in weeks.
MAiGRATE's automated pipeline handles every step of the regulated migration — with documentation generated at each stage that satisfies FDA data integrity requirements and EU GMP Annex 11. Governed under ISO/IEC 42001.
- Automated ingestion — structured extraction from Jama, DOORS, Codebeamer, Word, Excel, and legacy QMS platforms
- Intelligent mapping — AI-assisted field mapping with documented rationale for every mapping decision
- Data cleanup — automated cleanup algorithms with decision documentation for every transformation
- Validation — systematic source-to-target comparison at record level, not sample
- Loading — structured load into target platform with relationship preservation
- Audit trail — complete migration audit trail formatted for FDA and EU GMP review
MAiGRATE is frequently used to migrate legacy validation documentation into iQuality — enabling organizations to adopt the AI-native QMS without losing historical compliance records. And to Siemens Polarion for Design Control migrations from Word/Excel-based DHFs.
Book a Free Assessment.
45 minutes with a senior expert—not a sales rep. Written risk brief included. No commitment. You walk away knowing exactly where your biggest regulatory exposure sits.
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