System Validation Planning
With CFR Technologies expertise no steps will be missed and unwanted surprises are virtually eliminated. All validation and project requirements are pre-defined so all players are aware of their roles and expectations are clearly stated.
Deliverable: System Validation Plan
User Requirements Discovery
This is facilitated in a workshop format where all stake holders get involved to discuss how the system will be used in your environment. There is an educational portion to this engagement where an overview of available functionality and its possible applicability to your industry is explained. This ensures that all desired functionality is included in your project and that end users are aware of the full capabilities of virtualization.
Deliverable: User Requirement Document
Functional Specifications
Based on your User Requirements the Functional Specification document will describe how the virtualization software's features (functionality) meet the requirements.
Deliverable: Functional Specification Document
Design Analysis
During this phase how the functionality will be implemented and/or configured in your environment will be defined and documented. This will ensure that your infrastructure not only meets the vendor's specifications but will also define compatible components for future growth.
Deliverable: Design Specification Document
Installation/Operational/Performance Qualification
All protocols will be generated based on the Functional/Design Specifications and the vendors recommended procedures. Clients are encouraged to execute the scripts themselves to accelerate the learning curve, test execution training can be provided and we will be available to assist in Test Review and deviation resolution. However if resources are tight we can provide all the necessary resources to complete your project.
Deliverable: IQ/OQ/PQ Documents
Traceability Matrix
The relationship between all requirements, specifications and test cases will be recorded in a separate document. This ensures that all functionality is easily traced to the corresponding test cases.
Deliverable: Traceability Matrix Document
Risk Management/Risk Assessment
The FDA has issued guidance for a risk based approach to compliance; CFR Technologies can help clients document this aspect of a project.
Deliverable: Risk Assessment
Final Validation Report
Summarizes all testing, deviations and related activities into a clear and concise synopsis of the project.
Deliverable: Final Validation Report
System Maintenance and support
A template for a system operation and maintenance SOP is included with each project. CFR Technologies can also assist you with additional support SOP's such as; Disaster Recovery, Backup, Patches, Upgrades, Change Control.
Deliverable: Standard Operating Procedure(s)
