Can you still retrieve and explain GxP records from a retired application?

GxP is an umbrella term for regulated Good Practice environments, including Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).

Retiring a GxP application does not end the retention obligations for its records. Your eArchiving approach may need to preserve the records together with relevant metadata, audit trails, signatures, retention information and other context required for later review.

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Review one archive scenario

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Application retirement

Inspection readiness

Long-term GxP eArchiving

Legacy instrument data

Audit trail preservation

Archive gaps often become visible after system retirement

Shutdown plans usually cover hosting, licences, interfaces and data export.

They may give less attention to how authorised users will retrieve complete records, interpret audit trails or identify the applicable record version after the source application is unavailable.

Those questions are easier to resolve before decommissioning than after the project team has moved on.

What the guide helps you check

The guide helps your team assess whether a GxP eArchiving approach covers the questions that should be resolved before the source application is decommissioned.

Can you retrieve the full record bundle, not just isolated files?

Is the audit trail preserved with enough context to explain the record?

Are completeness checks defined for ingested records, attachments and metadata, and is the resulting evidence retained?

Will proprietary instrument data remain readable throughout its required retention period?

Can authorised reviewers retrieve the required information without receiving access to unrelated or restricted records?

Is retention still enforceable after the source application is switched off?

Before the source application is switched off

Use this self-assessment to identify evidence gaps before shutdown. Record the in-scope record classes and retention owners. Reconcile what moved and document exceptions. Test whether intended users can retrieve and interpret representative records without depending on the source application, and record the organisation’s validation, governance and shutdown decisions. The scope and retention requirements depend on the record class, jurisdiction, quality system and intended use.

See the GxP eArchiving Requirements checklist for detailed archive criteria. For the wider retirement process, see Application Retirement.

For teams preparing, reviewing or recovering from regulated system retirement

Quality and regulatory

QA, Quality Systems, Regulatory Operations, Data Integrity and Records Management teams.

IT quality and validation

IT Quality, CSV/CSA, validation leads and application owners for legacy platforms.

Typical systems

LIMS, ELN, eTMF, QMS, laboratory instruments, clinical trial systems and GxP-relevant workflow platforms.

Identify archive gaps before system shutdown

Use the guide to review whether your GxP eArchiving approach covers retrieval, readability, metadata, audit trails, retention responsibilities and evidence of ingestion. It supports an initial assessment and does not determine GxP compliance. For a broader framework, see the GxP eArchiving Requirements checklist.