QA Audit Preparation and Response
- Assist QA Department with preparation for an audit conducted by clientele or an inspection being conducted by a regulatory body
- Document and Data Review
- Conduct internal process audits to detect and correct non-compliance
- SOP writing
- Assist QA and operations staff in resolving Quality issues and develop action plans to correct deficiencies
- Assist QA with Audit Responses
- Assist with Part 11 Remediation and Compliance
- Qualify Excel Spreadsheets: Microsoft Excel is not Part 11 compliant. However, there are security and protective measures that can be implemented to decrease risk.
- Conduct Vendor Qualification and Maintenance Audits