Quality Services

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
  • 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