Project Execution

Example of potential projects that could be recommended and facilitated by CRSC:

Capability Assessment and Gap Analysis.
Standard Operating Procedures (SOPs) Writing and Implementation.
Risk-based Audit Planning and Conduct.
Governance and Vendor Oversight.
Inspection Readiness (IR) Program (Training, Mock Inspection, Response Writing).
Computerized System and Technology Assessment.
Quality Metrics and Dashboard Development.
Trial Master File (TMF) Assessment and Remediation.

Global Client Support

Customized support and advice for clients regarding:

Quality Management System (QMS) development and enhancement.
Proactive Quality by Design Principles.
Risk Management strategy plan.
Quality Expertise to augment your organization as you build your team.
Inspection Readiness/Inspection Preparation.

Are you Prepared for an Upcoming Inspection?

Mock Inspections

CRSC Supports Creating and Maintaining an Ongoing State of Inspection Readiness (IR) Across your Organization Through Risk Management:

Help to identify, document, and evaluate risks.
Take practical and feasible steps to control, mitigate, and remediate risks.
Risk-based Audit Planning and Conduct.
Governance and Vendor Oversight.
Inspection Readiness (IR) Program (Training, Audits, Support, Response Writing).
TMF Assessment and Remediation.
Quality Metrics and Dashboard Development.

CRSC Provides Services and tools in the Following Areas of Inspection Readiness:

Inspection Readiness Training for selected Subject Matter Experts (SMEs) or your entire organization.
Inspection Interview Coaching for practice responding to inspector/investigator questions and inspection scenarios.
Mock Inspections across GxP operations (GCP, GCLP, GLP, GVP, GDP, and GMP).
Remediation Support to quickly address compliance gaps, such as TMF and monitoring deficiencies.

Contact CRSC to get started

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