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Quality, safety and regulatory · OOS

“We have an OOS result, the batch is on hold, and the investigation hasn't reached a conclusion for weeks.”

Close OOS investigations faster and audit-ready

A result outside specification stops the batch, and every week without a root cause costs supply. CovaSyn puts the result in the context of the batch and comparable batches, checks the raw data for signs of lab error and delivers justified root cause hypotheses. Your QA decides on a basis that holds up in an audit.

Starting point

When you need this

  • An assay, impurity or dissolution result is out of specification, and the phase I lab investigation finds no clear error.
  • A peak appears in the chromatogram that was not there before, and nobody knows where it comes from.
  • The investigation has to move to phase II, and a structured list of possible causes is missing.
  • An auditor criticised investigations without a demonstrated root cause, and the next one should be properly documented.

If nothing changes

What it costs when the case stays open

  • The batch stays blocked while the investigation is open, and delivery to your customers is delayed.
  • An investigation without a demonstrated root cause becomes an audit finding.
  • Without an effective root cause, the same OOS comes back with the next batch.

Result

What you get

  • Result put in context

    The OOS result compared with its own batch, earlier batches and control charts, so it is clear whether this is a single event or a trend.

  • Raw data review

    System suitability, integration, calibration and chromatograms checked for typical signs of lab error, with the points where something stands out.

  • Root cause hypotheses with justification

    A list of possible causes from lab, material and process, weighted by the data, with the experiment that confirms or rejects each hypothesis.

  • Building blocks for the investigation report

    Data, evaluation and conclusions prepared so that your QA can take them into the investigation report and sign off.

How it works

From an open case to a signed-off report

  • 1. Describe the case

    In the initial call, 30 minutes on Microsoft Teams. We tell you honestly whether we can solve your problem.

  • 2. Send the data

    Confidential from the start. We run the evaluation, typically within 5 working days once we have your data.

  • 3. Sign off the report

    You receive the result with reasoning and input data. Your expert reviews and approves it.

CovaSyn

What we evaluate for this

Every number is calculated, not estimated. Every evaluation is documented with its input data and reasoning, so your expert can review and sign it off.

  • OOS and OOT recognised in context

    Detection of results outside specification and trend across all batches, with control charts for context.

  • Chromatograms reviewed traceably

    Review of integration and system suitability, so unusual evaluations become visible.

  • New peaks identified

    Molecular formula and structure proposals for unknown peaks from LC-MS data, classified as process impurity or degradation product.

Audience

Who it is for

For QC, analytical and QA teams at contract labs, CDMOs and API and drug product manufacturers who run OOS investigations and have to defend them to auditors and authorities.

What the computation does not replace

  • Whether a result is invalidated and whether a retest takes place is decided by your QA under your SOP. We deliver the basis, not the decision.
  • A root cause hypothesis is only confirmed once an experiment in your lab or plant supports it.
  • Measures and CAPA are set by you. The evaluation does not replace your QP's responsibility for release.

Insights

Read on

Questions

Common questions

How does an OOS investigation work?

First, in phase I, the lab checks whether there is an obvious lab error. If none is found, phase II follows with an investigation of manufacturing, material and process. Both must be documented, and a result may only be invalidated with a demonstrated root cause.

What to do when phase I finds no cause?

Then you need a structured list of possible causes and the data that supports or refutes each one. CovaSyn puts the result in context, reviews the raw data and weights the hypotheses, so your investigation continues in a targeted way.

Can I simply retest after an OOS?

Not without a reason. Testing repeatedly until a passing result appears counts as testing into compliance and is a frequent audit finding. A retest needs a documented justification and must be covered by your SOP.

How does an OOS investigation become audit-ready?

Every conclusion has to trace back to data an auditor can follow. CovaSyn delivers evaluation and justification together with the input data, so your QA can check and sign off every step.

Who can support us during an ongoing OOS investigation?

CovaSyn does this as Done-for-You: you describe the result and the state of the investigation in the initial call, we agree on scope, and you typically receive the evaluation within 5 working days once we have your data. Handled confidentially from the start.

Quality, safety and regulatory

Related problems we solve

Next step

Tell us about your OOS result.

30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.