Sustaining Compliance for Validated Systems – Client Support and Program Development

Our clients commit substantial time and money into validating systems and ensuring that they are released into production in both a reliable and predictable state. The validation effort is a small segment of the actual life of a system. The majority of a systems life is in the operational phase, where the system is used for its actual intended purpose.

With companies making such substantial investments in the developmental and testing phases of a system spent by companies, it is imperative that a rigid well-defined program be in place to ensure that these systems can be maintained in a “compliant” state. This is a term that includes more than just validation; "compliance" is a collective term that can generally be defined as “the ability of a system to adhere to the regulatory and internal / company guidelines and regulations which apply to it and to operate within the specified limits pre-defined for that system.”

COVEX offers a multitude of experience in the areas of sustaining compliance after the development and validation phases. Although this concept is not new, few companies have actually been successful in tying all these concepts together. Our staff has been at the forefront of developing complete compliance programs for clients. Our staff has also activity presented to the industry regarding the specific topics identified as crucial elements of sustaining compliance at both the corporate and the system level.

Covex Experience

System Inventory Structure and Definition (specifically, solving the “computer system versus 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 (i.e. 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 the core expertise of COVEX, which puts us in an excellent position to offer these compliance services. Rest assured that COVEX staff are trained in the principles of sustaining compliance; these principles are implemented for all clients during our validation work on a daily basis.