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Migrating design controls and quality records into an eQMS is a controlled records and system change—not simply a bulk file upload. The objective is to preserve each record’s content, meaning, relationships, approvals, and retrievability, then document that the new system handles them as intended.
For US-regulated manufacturers, the FDA’s Quality Management System Regulation (QMSR) took effect on February 2, 2026, and incorporates ISO 13485:2016 by reference. Although QMSR no longer uses separate requirements named Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR), the underlying evidence still needs to be documented and findable. The exact inventory and retention duties depend on the organization’s products, markets, and applicable requirements.
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What must a migration preserve?
A migrated record needs to remain understandable and usable as evidence—not merely present as a file. Preserve its content and meaning along with the context a reviewer needs to interpret it: identifiers, titles, product or project association, revision, approval or effective status, dates, authorship and approvals where recorded, and links to related records.
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Outbyte PC Repair FREERepair Windows errors before they cause bigger problemsFix Now →Outbyte Driver Updater FREEScan for outdated or missing drivers - takes under a minuteDriver Scan →FDA explains that QMSR’s design and development file contains or references records needed to establish compliance with design and development requirements. The medical device file contains or references current procedures and specifications used on the manufacturing floor. These descriptions do not prescribe an eQMS schema or a universal migration method. A practical way to maintain continuity is to keep the legacy index as a controlled crosswalk to the new records and their locations. FDA QMSR FAQ
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Depending on the organization’s products and requirements, the migration scope may include design inputs and outputs, reviews, verification and validation evidence, transfer records, design changes, risk records, and approvals, as well as linked quality records. Do not discard records simply because a legacy file name is no longer used.
How to plan and execute the migration
The sequence below is a practical framework derived from FDA’s risk, record-integrity, access, and retention principles. It is not a regulator-prescribed migration sequence.
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Set scope and ownership
Identify source systems and paper locations, product families, markets, record owners, and applicable retention requirements. Assign responsibility for the inventory, mapping, exceptions, acceptance decision, and ongoing access. Confirm the actual obligations for the organization rather than assuming one retention period or record set applies to every product or market.
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Inventory and classify the records
For each record, capture available identifiers, title, product or project association, revision, approval or effective status, dates, author, reviewer and approver information, source location, and retention status. Flag duplicates, superseded records, missing items, damage, and unreadable content for documented review and disposition. Do not silently omit them.
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Map record meaning and relationships
Create a controlled crosswalk from each source record type and its metadata to the destination objects and fields. Preserve relationships among inputs, outputs, reviews, verification, validation, transfer, design changes, risk evidence, and approvals where they exist. A reviewer should be able to determine what a record means, what it supports, and where to retrieve it in the eQMS. FDA’s guidance on electronic-record copies emphasizes preserving both content and meaning. FDA Part 11 Scope and Application
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Assess risk and define acceptance criteria
Document the intended use of the eQMS and migration functions, the records and activities that depend on them, and the consequences of failure. Assess potential impact on product quality, patient safety, and record integrity. Then define objective acceptance checks appropriate to that risk—for example, completeness, rendering, metadata, relationships, approval state, signatures, version history, search, retrieval, and exception handling. These are practical examples, not an FDA-mandated checklist.
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FDA recommends a justified, documented risk assessment: “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.” The agency’s February 2026 Computer Software Assurance guidance describes a risk-based approach for software used in medical-device production or the QMS; it does not prescribe one fixed set or number of test scripts for every migration. FDA Computer Software Assurance guidance
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Transfer records under controlled conditions and reconcile
Use an approved process with suitable access controls and change control. Establish source counts or other reconciliation baselines before transfer. After transfer, check records and linked metadata in the destination, including representative high-risk records, and document failed transfers, transformations, ambiguous mappings, and approved resolutions. Scale the depth of checks to intended use and assessed risk rather than relying on an arbitrary script count.
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Approve cutover and maintain retrieval
Obtain the organization’s required quality and system-owner approval. Confirm that users can retrieve records in readable form and that copies retain their meaning. Set archive, source-system access, and decommissioning arrangements only after confirming retention and inspection-access obligations. FDA discusses reasonable and useful inspection access and the preservation of records under applicable predicate rules in its Part 11 guidance.
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Control changes after migration
Manage corrections, remapping, configuration changes, and software upgrades through change control. Assess whether a change affects functions or records on which the organization relies, and reconfirm assurance or validation evidence where needed. FDA’s older General Principles of Software Validation guidance supports risk-proportionate effort based on intended use and the consequences of relying on software output; use it alongside the current 2026 Computer Software Assurance guidance, not as a migration-specific rule.
How much assurance evidence is appropriate?
Choose assurance activities based on what the eQMS and migration functions are intended to do, which records and processes rely on them, and the consequences if they fail. The system’s label alone does not determine the evidence required. A migration affecting approval state, record relationships, or retrieval may warrant different checks from a low-impact transfer, but the rationale should be documented and tied to intended use and risk.
FDA’s Part 11 Scope and Application guidance describes enforcement discretion for specified Part 11 validation, audit-trail, copying, and retention provisions. That policy is not permission to ignore applicable records requirements or weaken controls without a documented assessment: predicate-rule duties remain. The FDA guidance also calls for considering product quality and safety and the integrity, accuracy, reliability, availability, and authenticity of required records and signatures. Whether particular electronic-record controls apply depends on the organization’s records and circumstances.
What should the migration evidence show?
A defensible migration record should let the organization explain what it moved, how it mapped the records, what it checked, and how it handled exceptions. The evidence should be proportionate to the risks and obligations identified for the system and records.
- Approved scope, ownership, and applicable retention considerations.
- Source inventory and the crosswalk between legacy categories, metadata, and destination records.
- Documented risk assessment, intended use, and acceptance criteria.
- Transfer and reconciliation results, including counts or other baselines and checks performed.
- Exceptions, their disposition, and approvals for any accepted resolution.
- Evidence that records remain readable, meaningful, and retrievable, plus cutover approval and arrangements for retained source access or archives.
- Change-control records and reassessment of affected functions after relevant changes or upgrades.
How to evaluate an eQMS for migration needs
FDA does not compare eQMS vendors or certify a particular platform as suitable for a manufacturer. When assessing a system or implementation approach, ask whether it can support the organization’s intended use and demonstrate the controls it needs.
Quick Recap
- Can it preserve content, meaning, signatures, approvals, revision history, and relationships?
- Can users search for and retrieve records in a useful, readable form, including for inspection?
- Can the organization export or archive records while maintaining their context and access?
- Are migration activities, configuration changes, and relevant system events auditable and controlled?
- Can the organization document risk-based assurance evidence and handle exceptions?
- Can retention rules and the organization’s record obligations be supported without assuming one universal schedule?
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