Regulatory and Validation / GxP Document Migration

Validation produces a lot of documentation over time

Validation plans, specifications, test scripts, executed test records, summary reports, change control records, periodic reviews. Those documents are the evidence that a system is compliant, and they have to be retained, retrievable, and intact for as long as the regulation requires — which can be well past the life of the system they describe.

Moving those records from a legacy system, file share, or paper archive is itself a controlled activity.

Why migration needs care

These documents are records, not ordinary working files. Losing one, corrupting one, or breaking the link between a document and its approval history is a data integrity failure.

If metadata, signatures, dates, or approval history are lost or changed, the evidence has been compromised.

ALCOA plus
Attributable Legible Contemporaneous Original Accurate Complete Consistent Enduring Available

The principles that define data integrity all apply to the migrated records.

The destination system matters as well. If the destination holds GxP records, it needs Part 11 controls: audit trails, access control, and electronic signatures where signatures are used. Migrating compliant records into a non compliant system does not preserve compliance.

Migration as validation

We plan, carry out, and verify a GxP document migration as a controlled process.

Migration plan

Defines what moves, how, and what constitutes success.

Data mapping

Documents how each field and attribute in the source maps to the target.

Verification

Confirms that what arrived matches what left — by full comparison for critical records, by statistical sampling where volume makes full comparison impractical.

Migration report

Records the outcome and any deviations. The old system is retained or decommissioned under change control.

Making the archive useful

A migration can also make the archive easier to use. Legacy validation documents are frequently scanned PDFs nobody can search, spread across systems nobody fully knows. A migration into a structured, searchable platform turns a compliance archive into a working asset.

If the team can find a periodic review or the test evidence for a specific function in seconds, preparing the next validation is much easier.

SequoiaAT's work

SequoiaAT provides GxP document migration and validation support as part of its life sciences work, moving legacy validation documentation into systems that keep it current, searchable, and auditable.

GxPForge, the platform side of that capability →
Public work
10,000+

Regulated documents moved from AODocs to Veeva Vault for a biotech running clinical studies, with a trial migration first, every file hash checked and zero data loss.

Read the case study →