OrientSciences traceability guide

For traceability education only. This is not a product release, authorisation, safety claim or recommendation for human or animal use.

How a research record
should connect.

Traceability means being able to follow how a source, batch, test, document and technical decision relate to one another, while keeping claims distinct from evidence.

See the record trail

How it works

Keep the evidence
connected.

A traceable record lets a reviewer work backwards from a result to the material and process it represents. Good documentation controls revisions, preserves a record’s relationship to the batch and supports later retrieval. [1]

For computerized laboratory systems, printed output alone may not include the full electronic record used to produce a result. Secure, reliable and reviewable records matter when interpreting technical evidence. [2]

Five parts of a traceable record

A connected record,
from source to decision.

This guide is for document review and record design. It does not mean that any current catalogue record has completed these steps.

Source

Record the supplier, source reference, item identity and receipt context without overstating what the source alone proves.

Batch

Assign or retain a stable batch or lot identifier that can connect the physical material, label, analytical records and any later review.

Test

Associate each analytical result with the method, sample, acceptance criterion, date and the responsible testing context.

Document

Keep certificates, chromatograms, reports, specifications and revisions in a retrievable record with their relationship to the batch intact.

Decision

Record the technical review outcome, rationale, reviewer and boundary: a release decision is distinct from a marketing statement or authorisation claim.

Questions this guide answers

What should stay
connected and ready for review.

Why is a supplier document not enough by itself?

A document needs a clear relationship to the identified material and batch. The value lies in the chain: source, item, batch, method, result, document version and review decision.

Why preserve original data where possible?

A summary value or printed chart may not contain the full method, sequence, integration or audit context used to generate it. Reviewability depends on retaining records that are secure, reliable and retrievable.

Does traceability establish a clinical or regulatory claim?

No. Traceability is a way of organising records. It helps a reviewer see which material and records are connected; it does not authorise a product or prove a medical, safety or performance outcome.

Record checklist

Keep records
ready for review.

01
Source and item identification are recorded without unsupported quality claims.
02
The physical material and its batch or lot identifier can be matched.
03
Methods, samples, results and acceptance criteria remain connected.
04
Original records or reliable, retrievable copies are retained with revision control.
05
A review decision records the evidence used, boundary and responsible reviewer.