Solutions / Archiving
Standard21 CFR Part 11
RecordsAuditable
RetentionControlled

Inspection-ready imaging archiving for clinical trials.

A complete, controlled archive of every image, measurement and decision — structured so that it can be reconstructed and defended years after the study closes.

Regulatory Archiving

An archive built to survive inspection.

Regulators do not just ask for results; they ask how you reached them. Our archiving keeps the full imaging record — source images, reads, queries and audit trails — in a structured, retrievable form that reconstructs exactly what happened and when.

Built around 21 CFR Part 11 and GxP expectations, WIDEN maintains validated electronic records, controlled access and complete traceability. When an inspection comes, the evidence is already organised — not reassembled under pressure.

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What it covers

What the archive preserves.

Every artefact a sponsor needs to demonstrate the integrity of an imaging endpoint, retained under controlled conditions.

Complete imaging record

Source images, derived measurements and reviewer decisions retained together as a single coherent dataset.

Completeness

Validated audit trail

Time-stamped, attributable records of every action, compliant with 21 CFR Part 11 electronic-record requirements.

Traceability

Controlled access & retention

Role-based access and defined retention policies govern who can reach the archive and for how long.

Control

Inspection retrieval

Structured indexing means specific images and decisions can be located and produced quickly on request.

Retrieval

Keep your imaging record inspection-ready.

We will archive your study so the full imaging evidence chain is retrievable and defensible whenever it is needed.

Office
Via Agostino da Montefeltro 2
10134 Torino, Italy