Areas of Expertise
Innovative and Cost Effective Technology Solutions for Life Sciences
GxP Systems Implementation and Compliance
Pharmacovigilance (PV) Systems, Adverse Event and Drug Coding Systems, Clinical Data Management/Electronic Data Capture Systems, Systems Implementation (Installation, Configuration, Validation, Data Migration).
Internal Audits, Inspection Readiness Audits, Computer Systems Periodic Reviews, and Vendor Audits.
Over 30 years of experience implementing Product Safety and PV Systems for organizations of all sizes. Extensive knowledge of Oracle Argus Safety™ and Aris Global ARISg™/LifeSphere MultiVigilance™.
Computer System Validation
Modern and Flexible Systems Validation and Software/Systems Development Life Cycles for in-house and hosted/cloud systems that meet regulatory requirements.