COMPLIANCE TRAINING

Training program structure, refine training matrix to configure new learning management systems (LMS) & training support for employees.

COMPUTER SYSTEM VALIDATION

Aligned with GAMP 5 methodology, assisted computerized systems validation focused on medical devices, clinical research, pharma & laboratory work.

SYSTEM GAP ASSESSMENTS

Evaluation of enterprise resource planning (ERP) and quality management systems (QMS). Internal system appraisal and regulatory assessments.

INFRASTRUCTURE QUALIFICATIONS

Ensuring an adequate qualified GXP cloud-based or on-premises applications, infrastructure verification & technology stack control systems.

IT POLICIES & PROCESS DEFINITIONS

Develop & implement procedural controls
for establishing proper governance of
your technological assets.