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Quality Assurance for CDMO and CRO

Vendor Selection and Qualification

Conduct thorough research on potential CDMO/CRO vendors

Verify vendor's regulatory compliance and certifications

Assess vendor's track record and reputation within the industry

Evaluate vendor's expertise in the specific area of property management

Review vendor's financial stability and capabilities

Contract Negotiation and Documentation

Draft and negotiate comprehensive contracts with clearly defined terms and deliverables

Ensure contracts include provisions for quality assurance and adherence to regulatory requirements

Clearly outline responsibilities and expectations of both parties in the contract

Obtain necessary legal review and sign-off on the contracts

Initial Vendor Assessment

Conduct an on-site visit to the vendor's facility

Verify the vendor's infrastructure, equipment, and technology capabilities

Assess the vendor's organizational structure and quality assurance processes

Evaluate the vendor's capacity and ability to handle the scope of work

Quality Management System

Ensure the vendor has a documented quality management system in place

Review the vendor's standard operating procedures (SOPs) and protocols

Assess the vendor's training programs and qualifications of their personnel

Validate the vendor's change control and deviation management processes

Project Planning and Communication

Establish clear communication channels and points of contact with the vendor

Develop a project plan with defined milestones and deliverables

Regularly communicate project updates and progress with the vendor

Address any concerns or issues promptly and effectively

Performance Monitoring and Reporting

Implement a system for monitoring vendor performance against agreed-upon metrics

Conduct periodic audits or inspections of the vendor's operations

Review vendor-provided reports and documentation for accuracy and completeness

Address any non-compliance or performance issues through corrective actions

Risk Management

Identify potential risks associated with the vendor's services

Develop risk mitigation strategies and contingency plans

Regularly assess and update risk management plans as needed

Monitor and manage any identified risks throughout the partnership

Continuous Improvement

Encourage feedback from internal stakeholders and teams working with the vendor

Conduct regular reviews and evaluations of the vendor's performance

Identify areas for improvement and implement necessary changes

Foster a culture of continuous improvement and innovation with the vendor

Note: This checklist provides a comprehensive overview of the quality assurance process for property management organizations working with CDMO and CRO vendors. It is advisable to tailor the checklist to fit the specific needs and requirements of your organization.

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