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Sample management software — from registration to released CoA.

Sample management software in Swat iQua Suite tracks every QC sample through registration, testing, second-person review, approval and Certificate of Analysis, with locked results and a complete audit trail.

  • Specification version frozen at registration
  • Reviewer and approver can never be the analyst
  • Controlled Excel/CSV result import
  • Reagent and standard inventory built in
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Analysts working at benches in a pharmaceutical QC laboratory

Sample lifecycle

Five stages. One locked record.

Every sample moves through the same controlled stages — Pending, Ongoing, In Review, In Approval and Completed — and the screen shows exactly which of the ten working steps it has reached.

  1. PendingRegistered

    Sample registered

    Entered manually or converted from an approved client request. The specification version is frozen for this sample.

    Spec frozen

  2. OngoingWorksheet · labels

    Testing and result entry

    Worksheets and sample labels printed, results entered or imported. Submitted results lock.

    In testing

  3. In ReviewSecond person

    Results reviewed

    A reviewer who is not the analyst checks the results — or sends the sample back to result entry.

    Reviewed

  4. CompletedCoA

    Approved and released

    An approver independent of analyst and reviewer signs off; the CoA is printed and released.

    Released

A completed sample can be reopened when needed — the reopening and its reason are kept in the audit trail.

Key capabilities

LIMS sample tracking built for GMP evidence.

  • Enforced segregation of duties

    The reviewer cannot be the analyst; the approver cannot be the analyst or the reviewer. Checked on the server with no admin bypass, with optional e-signature on send-for-approval and approval.

  • Controlled result import

    Excel/CSV and instrument export files enter only through approved import profiles: template, preview with nothing saved, then commit with a reason — or reject.

    Integrations

  • Raw data kept intact

    Source files are stored with a SHA-256 fingerprint, can be superseded but not overwritten, and every download is controlled and logged.

  • CoA, worksheets and labels

    Certificate of Analysis, analyst worksheet and sample label printing — each switched on separately for your process.

  • Reagents and standards

    Per-site inventory of reagents, standards, columns and consumables with expiry status, server-issued reference numbers and logged, controlled labels.

  • GMP location routing

    Samples route automatically to the right lab area by drug class — microbiology, controlled or routine — with working-day turnaround metrics.

How it works

The core of the Swat iQua Suite LIMS.

Sample and testing management is where every other lab module meets. Specifications, stability pulls, client requests and lab materials all flow into the same sample record.

Registration fixes the rules

A sample is registered by hand or by converting an approved client sample request. The conversion is atomic, so one request can never create two samples. At registration Swat iQua Suite freezes the specification version the sample will be tested against, and the specification is locked while samples against it are open — a later edit cannot quietly change the limits for work in progress.

Results that cannot drift

Analysts enter results on screen or bring them in through an approved import profile. The import shows a preview before anything is saved, and the commit needs a reason. Once results are submitted they lock; if the reviewer finds a problem, send-back returns the sample to result entry with the history intact. The original instrument or spreadsheet file is kept alongside as raw data, so an inspector can trace each value to its source.

Instruments and materials checked

You can choose to block testing on instruments that are out of calibration, using the register kept in Instrument Calibration & Maintenance. Reagents and standards come from the lab inventory, whose definitions are copied from the material master so their identity always matches. Consumed stock cannot be returned to stock by mistake.

Release and reminders

After approval the CoA is printed, and a send-to-client gate controls when results leave the lab. For contract labs, portal users can download the CoA only after release. Overdue samples appear in the suite’s daily overdue digest, so ageing work is visible before it becomes a turnaround complaint.

Regulations

Designed to support lab data integrity rules.

  • 21 CFR Part 11

    Optional password re-authentication at review and approval, an audit trail with a reason for every change, and locked submitted results.

    21 CFR Part 11

  • ALCOA+

    Original files kept unaltered, attributable imports and controlled downloads keep raw data original, complete, enduring and available.

    ALCOA+

  • MHRA data integrity

    Independent second-person review and approval, enforced by the system rather than by procedure alone.

    MHRA data integrity

Keep exploring

Related LIMS pages

FAQ

Frequently asked questions

Can’t find your answer? Talk to our team — we reply within one business day.

What is sample management software in a pharma LIMS?

It is the part of a LIMS that records each sample from registration to release: which specification applies, who tested it, the results, the review and approval, and the CoA. In Swat iQua Suite every one of those steps is in one audit-trailed record.

Can results be imported from instruments?

Yes, through controlled import. Excel/CSV and instrument export files are accepted only through approved import profiles, previewed before saving and committed with a reason. The original file is kept as raw data. We do not sell bespoke instrument interfacing.

Can the same person test and approve a sample?

No. The reviewer must be different from the analyst, and the approver different from both. This is checked on the server and there is no administrator bypass.

What happens if a specification changes while samples are open?

Nothing changes for those samples. The specification version is frozen at registration and the specification is locked while samples against it are open.

Does it manage reagents and standards?

Yes. Reagents, standards, columns and consumables are tracked per site with expiry status, server-issued reference numbers and controlled, logged labels.

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