Regulations you must know before selecting an ERP system
identifies GCP, GMP and Med Devices regs you must consider when devising an ERP validation strategy.
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.
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