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LIMS moduleICH stability

Stability study management software — every pull on time, every result trended.

Stability study management software in Swat iQua Suite computes the pull schedule from time zero, turns each internal pull into a lab sample and produces ICH Q1E regression and shelf-life reports.

  • Pull dates computed on the server
  • No pulls before protocol approval
  • Late pulls flagged automatically
  • ICH Q1E trend and shelf-life report
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Scientist pipetting a sample in a QC laboratory

Study lifecycle

From protocol to shelf-life report.

A stability study moves from Draft to Approved/Active, then completes automatically when the last pull is done — or is terminated with a recorded, optionally e-signed reason.

  1. DraftProtocol

    Study drafted

    Product, batch, time zero, storage conditions and pull points. Protocol document attached.

    Draft

  2. ApprovedReviewer · approver

    Protocol approved

    Reviewed and approved by people other than the author. Pulls unlock and the schedule is set.

    Active

  3. PullsPer condition

    Pulls and testing

    Each internal pull creates a sample in Sample & Testing Management; external pulls are marked done.

    In progress

  4. CompletedICH Q1E

    Trended and reported

    Regression trend and shelf-life report on screen, as PDF or Excel.

    Completed

Storage locations are occupied when the study starts and freed when it ends — no spreadsheet of chamber space to maintain.

Key capabilities

A stability LIMS that keeps its own schedule.

  • Server-computed pull schedule

    Pull dates are calculated from time zero for each storage condition, with pull windows — not typed in by hand.

  • Approval before pulls

    Pulls are blocked until the protocol is approved. Row locking prevents the same pull being taken twice.

  • Late pulls flagged

    A late pull is allowed but marked “LATE (deviation)”, so it is visible for investigation rather than hidden.

  • “My pulls” and reminders

    A personal worklist plus a daily reminder digest at 07:00, and due pulls on the dashboard and compliance calendar.

  • ICH Q1E trend report

    Regression trend and shelf-life estimate per study, on screen, as PDF and as Excel.

  • Escalation to CAPA

    A failing or out-of-trend result can be escalated to a CAPA straight from the study.

    CAPA Management

How it works

Stability that runs inside the LIMS.

Because stability lives in the same Swat iQua Suite as testing and specifications, there is no hand-off between a stability spreadsheet and the lab.

Built around ICH storage conditions

Four ICH storage conditions are set up out of the box, and you choose which apply to each study. The server works out each pull date from time zero and the pull points in the protocol, applying the pull window you define. Protocol documents are stored with the study, and labels and a PDF summary can be printed.

Pulls become lab work automatically

When an internal pull is taken, Swat iQua Suite creates the sample in Sample & Testing Management against the right specification, so the analyst sees it in the normal queue. Pulls can be e-signed. Testing then follows the usual review and approval with segregation of duties.

Trend, conclude, act

Results feed an ICH Q1E regression trend and shelf-life report. When the last pull is done the study completes automatically. If a result fails or trends out, the study can escalate straight to CAPA, and an out-of-specification result is investigated in the OOS & Lab Incident Investigation module.

Regulations

Designed to support stability programme requirements.

  • ICH Q1A & Q1E

    Protocols built on ICH storage conditions, and evaluation of stability data by regression as described in ICH Q1E.

  • US FDA cGMP

    A written stability testing programme with scheduled pulls, recorded results and a traceable record of every late pull.

    FDA cGMP

  • WHO GMP

    Ongoing stability data available for review, with segregation of duties and an audit trail.

    WHO GMP

Keep exploring

Related LIMS pages

FAQ

Frequently asked questions

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

How does the software calculate stability pull dates?

The server computes each pull date from the study’s time zero and the pull points for each storage condition, applying the pull window you set. Nobody types the dates in.

Can a pull be taken before the protocol is approved?

No. Pulls are blocked until the protocol is approved, and row locking prevents a pull being recorded twice.

What happens if a pull is late?

It can still be recorded, but Swat iQua Suite marks it “LATE (deviation)” so it is visible for investigation.

Does it produce shelf-life reports?

Yes. Each study has an ICH Q1E regression trend and shelf-life report, available on screen, as PDF and as Excel.

Are external stability pulls supported?

Yes. An external pull is marked as done; internal pulls create samples in the lab automatically.

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