Situation

A manufacturer of specialty chemicals for beauty product additives discovered a LIMS compliance gap during an audit. The client engaged CSols Inc. to support SampleManager LIMS™ validation efforts related to closing the compliance gap.

Objectives

The client sought to respond to an FDA warning letter and required a full validation package to bring their laboratory into compliance.

Challenges

  1. Lack of internal validation resources and expertise: no single team member fully understood computer system validation (CSV) requirements for an FDA regulated environment
  2. Limited budget: the SampleManager LIMS validation project budget was too tight to bring on the recommended number of outside experts
  3. Configuration inconsistencies: the existing Thermo Scientific™ validation documentation did not apply to the site that required CSV, and additional test scripts were required

CSols’s Role in the Solution

  • Conducted on-site requirements gathering sessions
  • Trained client resources in validation execution principles
  • Assessed and documented as-built SampleManager workflows
  • Developed SampleManager LIMS validation plan
  • Developed user requirements specifications (URS)
  • Tailored Thermo Scientific documentation to client’s as-built SampleManager LIMS
  • Executed installation qualification (IQ) and operational qualification (OQ) protocols
  • Developed performance qualification (PQ) test cases and managed client resources during testing
  • Developed and maintained the traceability matrix
  • Developed the validation summary report

Benefits

  • Reduced regulatory compliance risk
  • Improved client knowledge and understanding of CSV regulations
  • Increased user satisfaction with SampleManager LIMS

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