Expertise
Laboratory Compliance & Data Integrity
Laboratory data supports nearly every regulated decision a company makes. We help analytical, QC and GLP laboratories build systems where the data is complete, attributable and defensible — and where the people generating it understand why that matters.
Laboratory quality and compliance
- GMP and GLP laboratory quality system assessment and build-out
- Out-of-specification and out-of-trend investigation systems
- Analytical method lifecycle, transfer and stability program compliance
- Sample management, reference standards, reagents and equipment control
- Laboratory documentation practices and contemporaneous recording
- Chromatographic data system configuration, audit trail review and user access control
- Laboratory investigations, remediation and analyst retraining programs
Data integrity
Data integrity findings rarely begin as misconduct. They begin with unreviewed audit trails, shared logins, unofficial spreadsheets and a workload that makes shortcuts feel necessary. We assess data flows end to end — paper and electronic — and design controls and review practices that fit laboratory throughput.
- ALCOA+ gap assessment across paper and electronic records
- Audit trail review procedures that are practical to sustain
- System access, privilege and configuration controls
- Data integrity training grounded in real laboratory scenarios
- Remediation programs following a data integrity finding
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