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LabWare REST vs Web Services: A Pharma QC Integration Case for CSV and Data Integrity

Pharmaceutical QC labs often connect LabWare with TrackWise, SAP/ERP, ELN, MES, and other systems.

However, these integrations create more than technical challenges. Teams must choose between REST APIs and SOAP Web Services while protecting data integrity, traceability, security, and CSV requirements.

Neither REST nor SOAP is automatically more GMP-compliant. Instead, compliance depends on how teams design, document, validate, secure, and monitor the interface.

Our team’s approach focused on a controlled integration strategy covering governance, documentation, testing, monitoring, and access control.

Challenges Faced

A detailed GAP analysis in Quality Management Systems is essential for identifying process deficiencies effectively.
  • Choosing REST or SOAP:SOAP is rigid and controlled; REST is flexible but needs strong governance.
  • Maintaining TrackWise Traceability: LabWare and TrackWise may exchange OOS, deviation, investigation, and CAPA information. The main requirement is clear traceability:
  • Sample → Result → Deviation → CAPA: REST provides flexibility, while SOAP provides more rigid transaction definitions.
  • Protecting SAP and ERP Data: Accurate mapping and transfer controls protect LabWare–ERP data.
  • Controlling ELN Access
    ELN permissions must clearly define whether the system can create or modify GMP-relevant LabWare data.
  • Preventing Hidden Interface Failures: Weak controls can cause duplicate records, wrong values, and excessive access.
     

Zamann Pharma Support’s Approach

  • Define an Integration Strategy: Set clear rules for when to use REST or Web Services. Then align those standards with IT, QA, and CSV requirements.
  • Create an API Catalogue: Document each LabWare interface, connected system, purpose, data object, endpoint type, and GxP impact.
  • Standardize CSV Documentation: Use common templates for URS, FS, risk assessments, and testing. Include positive, negative, error-handling, and security scenarios.
  • Strengthen Monitoring: Use central logging for REST and SOAP. In addition, monitor critical SAP, TrackWise, and ELN data flows and perform periodic reconciliation.
  • Control API Access: Define which systems and roles can access each API. Furthermore, include authentication, authorization, audit trails, and cross-system changes within CSV controls.

Results Achieved

  • Duplicate Deviations Identified: A LabWare REST retry created two TrackWise deviations for one event. The investigation identified missing idempotency and insufficient negative PQ testing.
  • 1,000-Fold ERP Error Detected: A unit-conversion factor was applied twice during SOAP data transfer. Consequently, the ERP result was wrong by a factor of 1,000, although LabWare displayed the correct value.
  • ELN Access Was Recontrolled: An ELN gained more LabWare write access than documented. The issue resulted in a major deviation, role redefinition, and interface revalidation.
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FAQ

1. How can a LabWare REST API create duplicate TrackWise deviations?

A retry can create duplicate records when the API lacks idempotency controls. In the source example, a network timeout triggered a second request and created two deviations for one LabWare event.

2. How can unit mapping cause incorrect LabWare-to-SAP results?

Incorrect conversion logic can alter transferred values. In the documented case, ERP expected mg/L while LabWare stored µg/mL. A double conversion caused a 1,000-fold error.

3. What controls are needed for ELN write access to LabWare?

Teams should define GxP status, read/write permissions, documentation, versioning, testing, and monitoring. They must also control which GMP-relevant records the ELN can modify.