
Instrument validation strategy, IQ, OQ, PQ qualification, risk-based approaches, execution and reporting across 21 CFR part 11, GLP, GMP, GAMP for all analytical instrument hardware platforms

Early Pharmacology, ADME, Assay Automation, PK/PD, Assay Development & Validation, Bioanalysis, Inventory Management etc. and the linked regulatory aspects of GLP and IND/NDA/BLA creation support.

ERP, Registration, Inventory, ELN, LIMS integration, laboratory instruments & robotics, project planning & lab audit tools, integration layer technology, instrument data standards (ADF, AniML, SiLA etc.), tech blueprints

CDM meeting 21CFR Part 11, EUANNEX Part 11 and GDPR, experience with numerous data analysis/review tools and processes suggested by GCDMP

"Always on", end-user support, proven scale, quality, processes and knowledge of scientific applications have a measurable impact on end-user efficiency, satisfaction and application downtime.

Assay development and validation, instrument data acquisition and integration, regulatory and QC data reporting, lab inventory and metrology, workflow automation and validation