Observations
1. Inadequate integration parameters (e.g., threshold, slope)
2. Insufficient chromatogram review and verification
3. Failure to document integration adjustments
4. Lack of training on chromatography software
5. Inadequate validation of chromatography systems
Company-Specific
1. Pfizer: Failure to validate chromatography data acquisition and integration software (2018)
2. Merck: Inadequate review and verification of chromatograms (2019)
3. GSK: Insufficient training on chromatography software for analysts (2020)
4. Novartis: Failure to document integration adjustments and re-integration of chromatograms (2018)
5. Johnson & Johnson: Lack of validation for chromatography systems and software (2019)
Recommendations
1. Develop and implement standardized integration procedures
2. Provide regular training on chromatography software and integration
3. Validate chromatography systems and software
4. Conduct regular audits of chromatography data and integration
5. Document all integration adjustments and re-integration of chromatograms
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