Our Services

Risk & Gap Audits

Conduct GxP audits and Gap assessment
Identify Compliance gaps, risks, and process weakness
Develop and Track CAPA plans
Support Inspection Readiness
Area included: GLP, GCP, GDP, data integrity, computerized systems, validation, documentation, training, and QMS

QMS Development

Design and implement GxP Compliant Quality Management System
Establish key quality processes and controls
Define quality governance, roles, responsibilities, and workflows
Integrate risk management and data integrity principle into QMS processes
Develop QMS metrics and dashboards

Inspection & Training

Support Inspection readiness and execution
Conduct mock Sponsor-CRO and Clinical Investigator Site Inspections
Provide inspection preparation training for employees
Develop and deliver GxP and regulatory compliance training
Maintain training effectiveness and compliance

System Validation

Plan and execute Software validation
Develop and maintain validation deliverables
Ensure data integrity, system security, audit trails, electronic record/signature and controlled access
Provide post-implementation management
Manage system upgrade, configuration changes and enhancement though Risk base impact assessment
Maintain validated state