The SOLABS QM Validation Package has been developed and is maintained with a risk-based approach to computerized system validation (CSV) GAMP5. As such, the EQMS validation package includes a complete set of documents including the Validation Plan, FDS, Test Scripts, Traceability Matrix, Qualification Protocols and 21CFR Part 11 validation assessment.
The validation package is sold as a non-recurring charge bundled with the initial implementation project costs.
The system will typically go through the following phases:
1. Initial implementation, where the core software functionalities are deployed and tested.
2. Following the system’s initial going live, a period of monitoring ensures that the system performs as intended in the production environment.
3. From that point the system is maintained in a validated state with operational procedures and formal change control to support changes.
4. Following the implementation of a change in the production environment, a period of monitoring may be necessary to ensure that the system continues to perform as intended.
The following validation components support the system throughout its life cycle:
The following validation components support the SOLABS QM Apps throughout their own independent lifecycle:
All of the above deliverables are available from SOLABS as part of our Validation Package.
Clients continue to benefit from our documentation and expertise for as long as they remain under our service, maintenance and support agreement.