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' 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
Click here to check out more project case studies that CSols has worked on.
Comments