Key Project Elements
- Vendor Audit
- Regulatory Knowledge
- CAPA
- Monitoring Program
- Change Management
Objective
Conduct an IT Quality Audit for a mid-sized biotech that focused on the collection, management and storage of clinical related data. Evaluate the performance and quality standards that had been implemented for the IT organization by QA.
CRO Effectiveness | Data Integration | Data Security and Protection
Solution
- Using our “Audit Practice Standards” to conduct a formal audit of the vendor.
- Using the foundational GDPR requirements to evaluate how data was managed in the organization and the security that was being implemented to transfer data to the customer.
- Developing an audit report and worked with vendor to finalize CAPA and monitoring program.
Benefits
- Created a program on continuous monitoring. This included the implementation of an improvement program, KPIs that allowed standardization of evaluation as well as securing data.
- Had to implement several SOPs (both vendor and client) to manage and secure data.
- Worked with IT organization to close gaps identified with “Open” system including data breach and protection.