In a paper based validation lifecycle process, there are many challenges and compliance risks related to executing validation protocols: illegible handwriting, spelling mistakes, missing signatures and associated evidences like attachments and/or screenshots. A much more troubling issue with paper- based execution is the potential for lost documents. In addition to the issues mentioned, – as with any paper document that requires approval – the processing time to review and approve a document can be inefficient and constrained by faxing, printing, scanning, and mailing validation documents and the associated speed which documents can be routed.
With ValGenesis the problems associated with paper based execution are completely eliminated. Through the electronic execution functionality available within the system, illegible handwriting is no longer an issue since content is entered electronically on the document being executed. In addition, spell check capabilities allow users to verify spelling prior to submission and adding screenshots or file attachments to any executed row can be achieved with a few mouse clicks. The system automatically adds the electronic signature of the user executing the test case with a date-time stamp to each row of the test case. Manually executed documents are often misplaced or lost during the transit, whereas losing documents is impossible with centrally managed electronic system. Furthermore, review and approval processes are accelerated, since documents are routed to reviewers and approvers in real time regardless of geographic location.
- ValGenesis provides users with the ability to add a screenshot or a file attachment to any test row being executed with a single mouse click.
- Once an executed document has been approved, it will be generated into a PDF format whereby the associated screenshots and files are appended to the same document.
- ValGenesis displays the full user name and date/time stamps for any test that is executed in the system. ValGenesis also quantifies the test results at the row and document levels with the required audit trail to meet compliance requirements.
- The system allows the splitting of protocol at the table level for execution. This function enables more than one user to execute the same document at the same time to expedite the process.
Validation Exception Management
Managing validation exceptions and discrepancies in a paper-based validation lifecycle process is very challenging and inefficient. There is also a compliance risk related when not creating validation exceptions and discrepancies on time during execution. In ValGenesis whenever there are failures during an execution, users have the ability to bundle one-to-many failures together to create exceptions (deviations). Exceptions within ValGenesis are managed electronically; therefore the exception handling process is much more efficient than paper. Once an exception is created, it is routed to a user for assessment. The assessment process is where the assigned user will determine the next course of action to be taken in order to resolve the execution failures. The system supports several different decisions and workflows that the assessor of the exception can take, with each decision maintaining its own unique workflow. For each exception ValGenesis also provides users with the ability to route the exception for review and approval before it is closed. Reports can be easily generated in the system to obtain metrics for exceptions and executions.
- Configurable Deviation/Exception Form – System provides users with the ability to design the exception/deviation forms to mirror current processes and terminology.
- Decisions on Deviation/Exception – There are several different decisions that can be made with each exception; each decision results in a different workflow. Any decision that is made during the assessment is subject to approval before the exception can be closed.
- Enables Collaboration – The system maintains a collaborative approach with regards to assessing and reviewing exceptions that occur. Through the collaborative capabilities you can be assured that exceptions are handled appropriately and in a timely manner.
- Full Visibility and Control for any Deviation/Exception – Transparency throughout the exception management process is assured. Users with the appropriate permissions are able to track exceptions, run reports to obtain execution metrics and view the real-time status with regards to the exceptions in the form of an audit trail