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How We Connected Market Complaints, Closed Lots and Retention Samples in LabWare 8

Market complaints often arrive after a pharmaceutical batch has closed. A hospital or pharmacist may report particles, an unusual odor, or a color change.

In this case, a global pharmaceutical company already used LabWare 8. The laboratory tracked retention samples in a dedicated workflow, while market complaints remained in a separate QMS.

For critical complaints, the laboratory needed to test retention samples and connect each investigation to the closed batch, product, and test results. Auditors had also requested a stronger system-driven link between these records.

The first idea was to use Project Manager. However, it could not support the required closed-lot traceability.

Our team therefore shifted the design to LabWare 8 Investigation Workflow and introduced product-linked investigation samples.

Challenges Faced

A detailed GAP analysis in Quality Management Systems is essential for identifying process deficiencies effectively.
  • Separate complaint and laboratory records: Complaints remained in the QMS, while retention samples and QC data stayed in LabWare.
  • Closed lots were difficult to link: Project Manager could not connect complaints to closed lots.
  • Project Manager lacked the right traceability: It could not provide a robust link between the complaint, closed lot, and retention sample.
  • Manual workarounds created risk:Excel, email, and free-text references were hard to validate and defend.
  • Investigation samples lacked product references: Initially, investigation samples did not have a robust link to the product master.
  • Specifications required manual handling: LabWare could not apply them automatically.
  • Release and investigation data were not fully aligned: The missing product reference limited QC comparison.

Zamann Pharma Support’s Approach

  • Used Investigation Workflow as the backbone: The team replaced the Project Manager concept with LabWare’s Investigation Workflow.
  • Linked closed lots directly: The investigation record could reference the actual closed lot related to the complaint.
  • Connected retention samples: Existing retention samples could be linked directly to the investigation.
  • Kept investigation activities controlled: The workflow supported status, responsibilities, root cause, conclusions, reporting, and audit history.
  • Created investigation samples within the workflow: Additional complaint-related testing remained inside the controlled investigation process.
  • Added product-linked investigation samples: The team introduced a product reference for newly created investigation samples.
  • Triggered the correct specifications: The product reference activated the existing LabWare specification logic.
  • Aligned retention and release testing: Retention results could then be compared directly with the original QC release results.
  • Connected the workflow to the wider PQS: The design supported complaint investigation, CAPA, change management, and pharmaceutical quality processes. The source also identifies 21 CFR 211.198, 21 CFR 211.192, ICH Q10, and GAMP 5 as relevant regulatory and computerized-system references.

Results Achieved

  • Closed lots became traceable: Complaint investigations could directly reference the relevant closed batch.
  • Retention samples became connected: The investigation linked the closed lot with its existing retention sample.
  • Specifications transferred automatically: Product-linked investigation samples received the appropriate specifications.
  • Manual specification handling decreased: Analysts no longer needed manual limits or ad-hoc test definitions for these samples.
  • Testing became directly comparable: Retention results could be compared with original QC release results.
  • The investigation gained end-to-end traceability: The workflow connected the complaint, lot, retention sample, testing, conclusion, and CAPA.
  • QA and QC gained a clearer inspection trail: QA and QC could present one structured record from complaint to CAPA.
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FAQ

The LabWare 8 Investigation Workflow can reference closed lots and existing retention samples. It can also manage investigation samples, responsibilities, conclusions, reporting, and audit history within one controlled workflow.

 

2. Why did Project Manager not work for closed-lot complaint investigations?

Project Manager could not link closed lots in the required way. Because market complaints usually arrived after lot closure, the design would have required manual or free-text workarounds.

3. How do product-linked investigation samples improve retention testing in LabWare 8?

The product reference triggers LabWare’s existing specification logic. Therefore, investigation samples receive the correct specifications and can be compared directly with original QC release results.