Validation Services
Because FDA-regulated companies must be compliant through each subsequent release of a product this means that for each hotfix, service pack, and major/minor upgrade, the portion of the system that has changed must be revalidated – often at considerable expense to the regulated organization. QUMAS significantly reduces these costs with its validation scripts created to satisfy GAMP4 and FDA guidelines. The templates eliminate the need for the clients to write their own while facilitating test and trace requirements. QUMAS support ranges from delivery of the templates and test protocols (many clients prefer to do the PQ piece themselves) to onsite support and management of the validation process. Support is flexible to meet the diverse needs of QUMAS clients and specifically structured to minimize the validation activities associated with future enhancements and configuration changes.
Services are based on the classic V-model and include QUMAS trained validation consultants to assist with any or all of the following activities:
- Validation project management
- Risk analysis
- Validation planning
- Software validation
- IQ/OQ/PQ Protocol development
- Test script authoring; execution, templates
- Creation of a Validation Summary Report
- SOP development
- Regulatory compliance assessments
- Change control
- Validation training
The project schedule, resources equipment and deliverables are presented as part of the project plan, prepared in coordination with the client.
Benefits
- Significantly reduce validation costs and expedite deployments
- Minimize the time and cost of validation activities associated with future enhancements and configuration changes
- Assures compliance with GAMP, cGMPs and the latest developments in 21 CFR 11, including the recent FDA move to a risk-based approach
If you have any questions, or wish to contact us directly, please contact services@qumas.com.