In an environment of increasing stringent requirements and limited resources, risk-based approaches are the only feasible option for companies to handle data quality enabling commercial success. Stark Associates deploys risk-based strategies along with risk-based quality and compliance, in order to reap the greatest benefits through team partnering with the in-house quality team to mitigate risk from compliance gaps for continual process improvement, in alignment with business objectives.
Quality Services
- Compliance governance
- Process document maintenance
- Process improvements
- Supporting and administration of compliance management tools
- Compliance dashboard
- Business as usual reports
- Customer survey/feedbacks
- Ad-hoc reports
Quality Assurance
- Project compliance (SDLC Consultancy)
- SDLC Documentation reviews
- Risk management
- Change management
- Compliance monitoring & reporting
- Deviation management
- Compliance issues investigation
- Audit and inspection support
Audit/Assessments
- Gap analysis for self-assessment
- Risk-based assessments
- SOP assessment
- GxP assessment
- Infrastructure assessment
System Validation
- Compliance support for validated systems
- Identify & guide on GxP requirements for validated systems
- Validation planning
- Test case/script creation & review
- Test execution
- Test Case execution review
- Test result documentation as per standards
- Generate computer system validation report