Software systems validation is a mandatory requirement for companies regulated by the Food and Drug Administration (FDA). The process of validating an enterprise software system involves running test scripts at the installation level (IQ), operational level (OQ) and the process level (PQ). These scripts are often long and time-consuming, and can take months, if not a whole year, to compile and run. Recognizing this incredibly difficult task of validation, ValGenesis has released a tool to validate these software systems, in an automated way.
ValGenesis has developed an Automation Framework called VATS, using this framework software validation life cycle process can be automated, including dynamic traceability matrix generation, dynamic test case generation and automated execution. Generated and executed test cases contents will be routed for review and approval through the controlled workflows available in ValGenesis.
Streamlining the validation process can have a tremendous effect on both a company's implementation time and personnel resources. Using ValGenesis VATS to automate the validation process of any Software system, will eliminate the effort and time requirement by as much as 90% - a 3-4 months validation project can be completed in less than two weeks. Furthermore, the ValGenesis VATS can be run by a single employee, and can eliminate the extensive resources dedicated to a typical validation project. Finally, ValGenesis VATS can compile the executed test cases into a single file in PDF format, with all the screenshots appended, in the same document. When audited by the FDA, or other governing body, the validation reports are immediately available for review.
Dynamic Traceability Matrix
ValGenesis dynamically builds Traceability Matrices that support forward and backward traceability and many-to-one and one-to-many relationships between test cases and requirements. Dynamically generated traceability matrices can be updated manually based on the requirements. During the automated test case execution, the Traceability Matrix is dynamically updated, based on the test case results.
Test cases will be dynamically generated from the automation framework, based on the specific requirements. The auto generated test cases will be reviewed and approved through controlled workflows available in ValGenesis.
Automated Execution of Test Cases
ValGenesis leverages the power of automated test engines such as QuickTest Professional (QTP) for validation automation requirements. The integrated system provides automated software validation that is fully compliant for the Life Sciences industry. In addition, critical phases of the validation process, including planning, risk assessment, requirement management, traceability, periodic review and change control can be harmonized through the use of an automated validation process. The automation test engine populates the test results on the MS Word templates managed by ValGenesis. These results include the User ID and Time Stamps, which are captured at the test case row level, meeting compliance requirements. The deviations observed in a test case can be tracked and traced back to the associated design elements and requirements.
ValGenesis enforces accountability during the entire execution process, from task assignment to approvals. ValGenesis can even capture screen shots at the test case row level and append as hyperlinks during the approval process, simplifying the review and approval process. The test results populated on the MS Word template in ValGenesis will be routed for review and approval, through configurable workflows. Electronic signatures available within ValGenesis can be configured to follow the corporate specific chain of custody requirements for the validation test cases executed through automated function.
The approved executed documents are securely stored in the ValGenesis library module, or can be pushed into any Document Management Systems (DMS) including Documentum, SharePoint portal etc. This allows clients to extend corporate DMS access control and audit capabilities to validation documents and data generated through an automated validation process.
Versions are maintained for content generated from the automation framework. All versions are securely stored in the Library module. ValGenesis is configurable to meet the specific document version management policy.
ValGenesis creates documented evidence for validation planning, requirements, risk assessment, periodic review schedules, traceability matrices and change requests, as well as the automated validation data, to provide lifecycle documentation in a single repository. Users can author, peer review, review and approve these lifecycle documents in a collaborative manner. Approved validation lifecycle documents are stored in the Library module in ValGenesis, or corporate Document Management Systems, with all the necessary security to ensure the integrity of the documents.