Migrating design controls and quality records into an electronic quality management system (eQMS) is a controlled records and system change—not a bulk file upload. A sound migration preserves each record’s content, meaning, status, relationships and retrievability, then documents risk-based assurance, reconciliation, exceptions and approval. For U.S. medical-device manufacturers, FDA’s Quality Management System Regulation (QMSR) took effect February 2, 2026; it incorporates ISO 13485:2016, while the records needed to demonstrate compliance remain necessary even though FDA no longer uses separate DHF, DMR and DHR requirements.
What the migration must preserve under the current U.S. FDA framework
The QMSR became effective on February 2, 2026, and incorporates ISO 13485:2016 by reference. FDA no longer retains separate requirements named Design History File (DHF), Device Master Record (DMR) or Device History Record (DHR). That change in terminology does not mean the underlying evidence can be discarded: design and development records and the current procedures and specifications used in manufacturing still need to be documented and available in the applicable records and processes. See FDA’s QMSR information and final rule.
FDA describes required record content, but does not prescribe a particular eQMS data model or universal migration method. Keep the old index or file structure as a controlled crosswalk during transition. For each legacy category, show the current process or file it supports, its identifiers and revisions, its relationships to other records, and how an authorized user can retrieve it in the new system.
The precise inventory and retention duties depend on the organization’s products, markets and applicable requirements. The FDA sources discussed here address the U.S. framework; they do not establish international obligations or organization-specific retention periods.
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Which records and context to inventory
Start with the records and locations in scope: paper files, shared drives, legacy databases and existing QMS repositories. Identify affected product families, markets, systems and record owners, then confirm applicable retention rules. The inventory is an operational starting point, not a substitute for determining the organization’s governing obligations.
Where applicable, include design and development records, approvals, change history, risk records, verification and validation evidence, transfer records and linked quality records. For each item, capture the information needed to interpret and retrieve it:
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- Identifier, title, product or project association, revision, and effective or approval status.
- Dates and available author, reviewer and approver information.
- Source location and retention status.
- Links to related inputs, outputs, reviews, verification, validation, transfer, changes, risk evidence and approvals.
Flag superseded, duplicate, incomplete, damaged or unreadable material for documented disposition. Do not silently omit it or assume a duplicate is disposable; resolve each case under the organization’s approved process.
How to plan and execute a controlled migration
The following sequence is a practical implementation framework inferred from FDA’s risk and record-preservation principles. It is not a regulator-prescribed procedure. Assign owners and retain evidence appropriate to the organization’s intended use, risks and obligations.
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- Inventory and classify. Capture identifiers, revisions, status, dates, available authorship and approval information, source location and retention status. Route questionable or exceptional records for documented review and disposition.
- Map records and relationships. Create a controlled crosswalk from source record types and metadata to destination objects and fields. Preserve relevant relationships, not just files. The goal is for a reviewer to understand what a record means and how it supports design and quality history.
- Assess risk and set acceptance criteria. Document the eQMS and migration functions’ intended use, the records and activities that depend on them, and potential effects on product quality, patient safety and record integrity. Set objective checks proportionate to risk. Examples include completeness, accurate rendering, metadata, relationships, approval state, signatures, version history, search and retrieval, and exception handling. These are practical examples, not a checklist quoted from FDA.
- Transfer under control and reconcile. Use an approved process with access controls and change control. Establish source counts or other reconciliation baselines; inspect representative high-risk records and verify destination files and linked metadata. Record failed transfers, transformations and ambiguous mappings, along with their approved resolutions. Scale assurance evidence to intended use and risk.
- Approve cutover and preserve retrieval. Obtain approvals required by the organization’s quality and system-owner procedures. Confirm users can retrieve records in readable form and that copies preserve content and meaning. Set source-system access, archiving and decommissioning only after checking retention and access obligations.
- Control post-migration changes. Manage corrections, remapping, configuration changes and software upgrades through change control. Assess their effect on assured or validated functions and reconfirm evidence where needed.
How much assurance and validation evidence is appropriate?
FDA’s February 2026 Computer Software Assurance guidance describes a risk-based approach for software used in medical-device production or the quality management system. It supersedes the September 2025 final guidance. For migration work, the practical implication is to define intended use, identify relied-on functions and records, assess potential impact, and retain assurance evidence commensurate with that risk. FDA does not prescribe one fixed package or number of test scripts for every eQMS migration. See FDA’s Computer Software Assurance guidance.
FDA’s Part 11 Scope and Application guidance recommends a justified, documented risk assessment that considers product quality and safety and the integrity, accuracy, reliability, availability and authenticity of required records and signatures. FDA states: “We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity.” See Part 11, Electronic Records; Electronic Signatures—Scope and Application.
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That guidance describes enforcement discretion for specified Part 11 validation, audit-trail, copying and retention provisions. It is not permission to disregard applicable predicate-rule duties or weaken controls without a documented assessment. The older General Principles of Software Validation guidance remains useful supporting context: validation effort should reflect intended use and the consequences of relying on software output, and changes or upgrades should be assessed for their effect on used functions. Use it alongside the current 2026 assurance guidance, not as a migration-specific rule.
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Migration is not complete merely because files open in the destination. FDA’s Part 11 guidance discusses copies that preserve record content and meaning, as well as reasonable and useful access for inspection. Accordingly, define how records will be retrieved and presented, and verify that the migrated representation retains the context needed to interpret them. Applicable predicate-rule duties remain relevant even where FDA describes enforcement discretion for certain Part 11 provisions. See the FDA guidance on Part 11 scope and application.
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Do not decommission a source repository until retention, access and retrieval obligations have been assessed and an approved archive or access arrangement is in place. Record reconciliation results, exception dispositions, approvals and retrieval checks in a way that is appropriate to the migration’s risks and the organization’s requirements.
Questions for evaluating an eQMS or migration approach
FDA does not compare vendors or certify a particular eQMS as compliant. Use the following as evaluation questions derived from record-preservation and risk principles, not as evidence that a product is FDA-approved:
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- Can the system represent the organization’s intended uses, record types and required relationships?
- How are content, meaning, signatures, approvals, revisions and history preserved during import and export?
- Can users search for and retrieve records in a readable, inspection-useful form?
- What auditability, access control and change-control evidence is available?
- How can the organization document risk-based assurance for the functions it will rely on?
- How are failed transfers, ambiguous mappings and other exceptions surfaced and resolved?
- Can the organization meet its own retention rules, including when records must be archived or exported?
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