FDA Compliance services
Covex can work with your senior staff to develop a Compliance Program that includes high level policies for Quality Management and System Development Life Cycle as well as more detailed procedures for the areas listed below. We can design a custom program specific for you or work within any of the industry standards such as GaMP, IEEE, etc.
- Sarbanes Oxley Act Assessment and Remediation Work
- Change Management
- Configuration Management
- Good Documentation Practices
- Testing and Qualification Standards
- Contingency Planning and Disaster Recovery
- Systems Administration
- Periodic Reviews and Performance Monitoring
- Incident Reporting
- Preventative Maintenance
- Backup and Restore / Archiving
- Risk Assessments
- 21 CFR Part 11 Electronic Records/Electronic Signatures
Covex can also audit existing programs and develop a gap analysis and remediation report outlining any deficiencies and/or risks within those programs and recommend remediation activities to eliminate those risks.
Covex offers classroom training on all of the policies and procedures listed above. We also offer computer based training programs designed specifically for you through our partner Systems Engineering Inc.
Covex maintains a staff of qualified auditors who perform both supplier audits and internal program audits/gap analysis. Our auditors are certified by the American Society for Quality (ASQ) and have received their Certified Quality Auditor status (CQA). We have currently completed audits around the globe including Japan, Germany, Ireland, England, Belguim, France, and Puerto Rico.