Sustaining Compliance for Validated Systems

Client Support and Program Development

After the development and validation phases, Covex offers you a multitude of experience in the areas of sustaining compliance. Although this concept is not new, few companies have actually been successful in tying all these concepts together. Our staff has presented to the industry specific topics identified as crucial elements for sustaining compliance at both the corporate and system levels.

 

Covex Experience

  • System Inventory Structure and Definition (specifically, solving the “computer system vs. equipment” problem)
  • Corporate Quality Management System Enhancements
  • Corporate and System Level Procedures Governing In-Production Compliance
            • Change Management / Control and Configuration Management
            • Periodic Review and Performance Monitoring
            • Backup, Archiving and Restoring along with Disaster Recovery
            • Other Operational Procedures (e.g., Use, Administration, etc.)
  • Library and Infrastructure Development
  • Metrics and Reporting

 

Compliance must be built into the system during early phases of the Validation Life Cycle and through robust corporate planning. Validation is our core expertise, which puts us in an excellent position to offer you these compliance services. Rest assured that Covex consultants are trained in the principles of sustaining compliance; these standards are implemented for all our clients, on a daily basis, during our validation work.