LIMS Validation for Biotech Scale-up
Risk-based CSV program package (URS/FRS, RA, IQ/OQ/PQ, TR) cut validation cycle time by 30% while meeting Annex 11 expectations.
Risk-based CSV program package (URS/FRS, RA, IQ/OQ/PQ, TR) cut validation cycle time by 30% while meeting Annex 11 expectations.
QMS harmonization, SOP suite, and inspection‑readiness program reduced deviations by 22% in the first quarter.
Controlled AI tooling auto-generated test evidence and summaries, improving coverage and auditability.
Defined intended use, risk stratification, dataset governance, model versioning, and monitoring controls to operate AI under GxP with clear audit trails.
Built calibration program, uncertainty budgets, and instrument lifecycle docs (DQ/IQ/OQ/PQ) to pass third‑party accreditation.
Led target architecture, governance, and implementation of API/ETL pipelines and master data governance to eliminate manual transcription, improve data integrity, and accelerate batch release.
Implemented LIMS with audit trails and user controls; trained staff on ALCOA+; reduced transcription errors by 40%.
Established control framework, evidence collection process, and SDLC/change-control practices to support SOC 2 audit readiness without slowing delivery.
Designed target architecture and integration plan for a payments/data platform, improving traceability, reducing manual reconciliations, and enabling real-time reporting.