GAMP5 models and methodologies for upgrades and implementations.
21 CFR Part 11 technical and procedural evaluation and testing.
Computer System Validation (CSV).
Laboratory Systems Validation Chromatography, LIMS, and Electronic Laboratory Notebook (ELN).
QSR 820 / ISO13485 compliance assessments and remediation.
CAPA Systems Workflows and Validation.
Current Good Manufacturing Practices consulting including: Gap Analysis and Risk Asessments.
Project Management and Metrics,
Supply Chain Management and Audits.
Quality Documentation: Plans/Reports, SOPs, IQ,OQ and PQ.
Cloud-based Systems Validation for GMP relevant applications.
Requirements gathering and traceability to Test Plan.