Industry
Laboratories
GMP/GLP laboratory audits, data-integrity remediation and CSV for QC and contract testing laboratories.
Overview
Quality-control and contract testing laboratories are a primary focus of data-integrity scrutiny, with chromatography and LIMS systems under particular regulatory attention.
PharmExpert supports laboratories with data-integrity audits and remediation, CSV of laboratory systems, and quality-system strengthening that withstands inspection.
Regulatory challenges
- Data integrity in chromatography and LIMS systems
- Audit-trail review and access control
- OOS/OOT investigation rigor
- Method validation and transfer
- Laboratory computer system validation
How we help
- Laboratory data-integrity audits and remediation
- CSV of CDS, LIMS and laboratory systems
- OOS/OOT and investigation improvement
- Quality-system and SOP support
- GMP/GLP laboratory audits
Relevant Services
Data Integrity Assessment & Remediation
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Data Integrity Solutions
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Computer System Validation (CSV) / Computer Software Assurance (CSA)
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CAPA Development & Effectiveness Verification
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Quality & compliance support for laboratories
Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.