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
- Lack of internal validation resources and expertise: no single team member fully understood computer system validation (CSV) requirements for an FDA regulated environment
- Limited budget: the SampleManager LIMS validation project budget was too tight to bring on the recommended number of outside experts
- 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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