Validation Package | SOLABS | 21CFR Part 11 Validation

Validation Package

Validation Package
and SOLABS QM Life Cycle

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.

SOLABS QM System Lifecycle Approach

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.

Optionally the following may take place:

    • APPS are deployed and tested.
    • System interfaces are designed, deployed and tested.
    • Data migration activities are carried out and verified.
    • Reports supporting compliance decisions are deployed and tested.

Changes requiring change control
(this is not an exhaustive list)

    • System updates (fixes, minor updates, upgrades)
    • Deployment of new Processes
    • Design and deployment of new system interfaces
    • Data archival activities

1. SOLABS QM Core Software Validation Strategy

The following validation components support the system throughout its life cycle:

    • SOLABS QM Core Software Functional Specifications
    • SOLABS QM Core Software Configuration and Design Specifications
    • Client Environment Compatibility Assessment
    • SOLABS QM Core Software Configuration
    • SOLABS QM Core Software Installation Qualification
    • SOLABS QM Core Software Operational Qualification (and Test Scripts)
    • SOLABS QM Core Software Traceability Matrix
    • SOLABS QM Performance Qualification
    • Verification of Data Migration exercises
    • Verification of SOLABS QM reports

2. SOLABS QM APPS Validation Strategy

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.