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| ValGenesis |
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An Enterprise Validation Management and Tracking System
ValGenesis is the only software solution offering 100% paperless validation management to cut validation cycle time in half, enforce consistency and compliance in the corporate validation process. ValGenesis is designed to automate, manage, and track the entire validation process – from generating validation document numbers to electronic execution of validation protocols. The solution was designed to overcome the inherent flaws associated with paper-based validation processes and to deliver the benefits of an electronic system. ValGenesis is an ideal solution to improve the efficiency of the entire validation life cycle, enhance the quality and consistency of validation protocols, provide a valuable line of defense against internal or FDA audits, and reduce the overall costs of validating entities.
Benefits of Implementing ValGenesis
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Track validation status in real time |
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Ensure data integrity and accountability, with complete audit trails capturing user ID, date, and time stamps |
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Create consistent validation documents via templates |
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Automatically generate unique, consistent validation document numbers |
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Systematically control and store documents securely for easy retrieval |
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Dynamically create audit trails for development, execution, and approval tasks for real-time retrieval during audits |
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Manage complex revalidation schedules |
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Capture spelling mistakes or typos during the execution of validation document test scripts |
The Advantage of ValGenesis
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Eliminate task and approval delays through the entire validation process |
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Enhance the quality and consistency of validation documents |
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Provide a valuable line of defense against internal or FDA audits |
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Reduce the overall costs of validation |
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Reduce the validation cycle time by 40-50%. |
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Stay in Compliance |
Highlights of ValGenesis Design
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Modular Construction |
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Web-based System (N-Tier Architecture) |
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Fully Configurable Application |
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User-friendly Graphical User Interface (GUI) |
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Role-based Security |
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Relational Database Design |
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Compliance with 21 CFR Part 11 |
Features of ValGenesis
Track Validation Status and Make Decisions in Real Time
In the current manual paper based system tracking the validation status, storing and retrieving the protocols tasks are time consuming and inefficient particularly in light of computer technologies that are capable of conducting searches in a few minutes.
ValGenesis eliminates the amount of time that is otherwise spent searching documents manually. With ValGenesis, a validation document can be stored and retrieved in real time.
Inventory Report Manager
The Inventory Report Manager allows you to attain the validation status of any entity corporate wide in real time. The inventory report manager stores entities in a tree hierarchy to simplify navigating to a specific validation document and tracking the validation status. Once the specific validation document has been found and clicked on, a report outlining all entity related information along with a complete audit trail with the user ID and date and time stamps captured for each activity that has occurred will appear.
Dashboard
Through the Dashboard Feature, users can get a quick glimpse of the validation status of any entity registered in the system in real time upon logging into ValGenesis. The drill down dashboard provides a valuable decision support tool for allocating human resources, maximizing validation team efforts, and locating the cause of any delays.
Barcode Scanning
ValGenesis creates unique barcodes for every entity registered within the system. The barcodes can be printed on an adhesive label and then physically attached to the entity. With a simple hand held scanning device, you are able to attain the validation status of any system at the production floor. In the event of FDA or internal audits, the barcode feature will expedite the audit process.
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Workflow driven Validation Protocol development and approvals
ValGenesis was designed to allow validation protocols to be developed in a collaborative manner by a group of users enhancing the quality of validation document produced. Following GDP (Good Document Practice) requirements, ValGenesis enforces the version control and sequence of approvals. Protocols will be in the loop with the developer and approvers until the protocols have been successfully approved by all approvers selected in the approval workflow.
Improve Document Consistency through Templates
You can create and register any number of validation document templates through ValGenesis to enforce document consistency throughout your organization. Configurable Headers and Footers are attached to each template pulling metadata, such as the approver and when it was approved etc., dynamically from the database. Documents under development must be completed on the predefined templates enforcing consistency across the board.
Transfer Assigned Tasks
Users that are unable to complete assigned tasks have the option of transferring the tasks. A transferred task must be routed through an approval workflow before the transfer can be completed. Allowing users to transfer the tasks ensures that human resources are maximized and that tasks are completed on time
Time Bound Review Workflow:
The review function provides the developer with the ability to route the document for review after the development and execution process. This feature allows selected reviewers access to the document simultaneously. By routing the document for review in tandem, the length of time for review is reduced dramatically. |
Electronic Execution
ValGenesis is the first product in the market that is capable of allowing you to conduct validation execution tasks online to achieve a 100% paper less validation process. ValGenesis does not mandate executing documents electronically and is equipped with a manual execution option. The electronic and manual execution options built into ValGenesis gives you tremendous flexibility in deciding how to execute documents.
Electronic Execution
Electronic execution feature in ValGenesis was designed to eliminate many of the issues currently surrounding manual execution methods. Some of these issues include physically storing executed documents, losing or misplacing executed documents, scanning documents to an electronic format once the execution has completed, illegible hand writing and data entry errors on executed documents. Execution can be quantified by attaching screen shots and supporting documents at the test case level or at the document level.
When executing a document electronically, for each test case row the user ID with date and time stamps is captured. Once the execution has completed, the executor of the document can route the executed document along with a summary report and additional supporting documents for approval.
Workflow Driven deviation management
During the execution, any test case failures will initiate the exceptional condition (deviation) template whereby the executor will assess the severity of the occurrence and assign a severity level. Each exceptional condition (deviation) will be resolved through a dedicated controlled workflow.
Manual Execution
For those instances when executing a document online is not possible, or for those firms that prefer to execute protocols following the traditional manual process, ValGenesis has a manual execution option available. Once an execution task has been assigned to a validation engineer, the validation engineer can print the test cases to execute the protocol. Once the protocol has been manually executed, the protocol can be scanned and uploaded into ValGenesis and routed through an electronic approval workflow. |
Create Revalidation Schedules for Critical GxP Entities
ValGenesis manages complex revalidation schedules to ensure that critical GxP entities are revalidated on time. When creating a revalidation schedule, selected groups of users can be alerted of any impending or delayed revalidation tasks through e-mail or through the task alert feature. Once the schedule has been created, it is routed through an approval workflow. Approved revalidation schedules are registered in ValGenesis and can be viewed through the revalidation schedule calendar. |
Be Prepared for Surprise FDA and Internal Audits
When it comes to FDA or internal audits, preparation is the key to success. Ensuring that all your ducks are lined up in a row will expedite the process and ensure that the inspection will result in a favorable outcome. In the event of an FDA or internal audit, ValGenesis generates complete audit trails with User ID and Date and Time stamps captured for every activity. |
Eliminate Time Delays in the validation process
The Task Alert Feature in ValGenesis is a valuable tool in eliminating time delays associated with assigning, accepting, and completing specific validation tasks. Once a task is routed to a user, ValGenesis will send out a hyper-linked message regarding the impending task. By clicking on the hyper-linked message, the applicable screen for the task will appear and the user can commence completing the assigned task. |
Eliminate Approval Delays with the Proxy Approval Option
Eliminate delays in the approval process by selecting the proxy approval option during approval configurations. In the event that a principal approver is unable to complete the approval task within the allotted time frame, the approval task will be routed to the proxy approver. |
Configure ValGenesis to meet your needs
ValGenesis is fully configurable giving you the most flexibility in terms of tailoring the application to meet your corporate needs specifically. A designated system administrator is capable of carrying out any required changes to mirror corporate operating procedures without any special programming skills required. The advantages of its configurable design mean that your RFS (Ready For Service) time is reduced and the ROI (Return On Investment) can commence immediatel |
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