Track Validation Status in Real Time 
In the current paper-based validation process, tracking validation status of any system, equipment or instrument is time consuming and very often submerged in a sea of paper. Overall, validation managers and supervisors spend an inordinate amount of time searching out both validation status and documents during the process. ValGenesis is designed to provide real time, corporate wide validation status in just a few mouse clicks, providing a holistic view of a company’s validation status and easily identifying bottlenecks, which expedite the validation process. To ensure its efficiency, ValGenesis offers three intuitive ways of tracking the real time validation status of any entity (system, instrument, equipment etc.) corporate wide.
1. Tracking Validation Status with Inventory Report Manager
ValGenesis is designed with a drill down Inventory Report Manager that allows for the tracking real time validation status on any system, equipment, instrument etc. that is registered in the system. The Inventory Report Manager stores entities in a user-friendly tree hierarchy for simplified navigation. The Inventory Report Manager saves a significant amount of time that would otherwise be spent tracking the validation status of an entity.
2. Tracking Validation Status with Dashboard
ValGenesis also provides a dashboard that furnishes instant access to the validation status of any validation document currently in the development or execution phase of the validation life cycle including documents awaiting assignment, under process, or pending approval. Upon logging into ValGenesis, users with an appropriate role can view the validation document status of any entity registered in the system in real time.
This provides a valuable decision support tool for allocating human resources, maximizing validation team efforts, and locating the cause of any delays.
3. Tracking Validation Status with Barcode
The bar code feature is a tremendous aide for a number of reasons. When scanning an entity on the production floor, users can determine the real time validation status of any systems, equipment, instrument etc. This significantly reduces the time currently spent on retrieving documents from a document repository and provides assurance to withstand scrutiny by any internal, regulatory or other external audits. In short, a tremendous amount of time is saved through the bar code feature as it allows entity specific validation information in real time on the production floor.
Enforce Consistency in the Validation Process
One of the primary challenges in the paper based validation process is maintaining the consistency of the validation documents. In fact, validation consultants and engineers may use different templates for the validation document development, which may lead to inconsistencies in the validation process. But the end user—who is ultimately responsible for the compliance—might not want several consultants and engineers adopting several different validation templates, each with different courses of actions, vocabularies, and document structures. To that end, the corporate validation procedure requires the incorporating of certain system, equipment, instrument related information such as model numbers, version numbers, etc., in the validation documents. Often these requirements are overlooked and may lead to non-compliance.
In ValGenesis validation consistency is enforced through the use of validation document templates. This leads to validation document consistency and enforces compliance in the validation process. During the development and execution, the protocols will be populated with entity related information such as a model number, version number, etc., from the database. Consistency in the validation process can be enforced across the site/company for use with the same template for the specific validation task.
Reduced Validation Cycle Time
During the manual validation process, the review and approval cycles are time consuming and uncontrolled by the initiator. In ValGenesis, the validation document development workflow is fully controlled by the application thereby improving the quality of validation documents produced. When a document development task is assigned, the validation engineer assigned to the task will be alerted by the application. Once the document is developed and submitted, reviewers and approvers are notified through the application. Essentially, ValGenesis improves the communication between assigners, developers, reviewers and approvers resulting in a more efficient validation process.
Time Bound Review Workflow
The review function provides the user 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, permitting comments by all those involved. By routing the document for review in tandem, the length of time for review is reduced dramatically. Moreover, granting reviewers and approvers the ability to view all comments pertaining to the document allows true collaboration as well as increased document quality.
Approval Workflow with Proxy Approvers
ValGenesis is equipped with controlled and configurable approval workflows with a proxy approval option, the proxy approval option eliminates delays associated with paper-based approval workflows, which include approvers failing to complete approval tasks on time. With the proxy approval option, once the allotted time has passed without response from the principal approver, the approval task is routed to the proxy approver for approval.
The approval workflow in ValGenesis also eliminates delays caused by lost or misplaced validation documents. Since the approval is completed electronically, the possibility of losing or misplacing a document is eliminated entirely. Electronic signatures available with ValGenesis can be configured to follow the corporate specific chain of custody requirements and to enforce validation procedures and requirements.
Stay in Compliance
Recent warning letters and citations from the FDA indicate that missing validation documents, inconsistent documentation, disobedience to Validation Procedures and/or Master Validation plans etc., are contributing factors for non-compliance. The cost of non-compliance can be exorbitant and includes a range of penalties from the relatively minor--such as additional inspections, lost production time, or un-sellable products--to more severe costs--such as recalls, plant shut downs and company fines. Another difficult and significant cost can be related to public relations. The media may decide to feature non-compliance issues, without regard to how serious a problem may actually be to an organization. The financial affects of non-compliance on a mid-market business could come close to catastrophic, causing the small manufacturer to go out of business.
ValGenesis can be configured to enforce the consistency in the validation documentation through templates. As engineers and consultants are compelled to use the preconfigured template for specific validation document types, ValGenesis takes care of populating the required information including model numbers, version numbers, etc., on the validation documents as configured to meet the compliance requirements. Document review and approval workflows follow the Good Document Practice (GDP). The revalidation schedule module with revalidation calendar and task alert feature eliminates the possibility of missing the revalidation task of GxP entity. All deviations are handled through controlled workflows. The developed and executed documents are available in the electronic format with read only access and with print controls. In brief, ValGenesis can be configured to impose compliance and consistency in the corporate validation process.
Reduced Cost of Validation
One of the greatest challenges facing regulated companies is the high cost associated with the initial validation, subsequent change management and revalidation to maintain the validation status throughout the life of the entities. In fact, costs associated with traditional paper based validation can represent approximately one-third of the total resources required for an overall implementation. With traditional manual validation processes, the hard costs also include significant amounts of time for reviews and approvals of developed and executed documents, as well as time to manage the results and track the validation status and protocols. Unfortunately, these high costs can also discourage life science companies from new innovation, and compromise the ability to bring new products to market.
ValGenesis reduces the validation cycle time and costs by 40-50% by proving the following features and functions:
- Real time Validation Status: Eliminates the time requirement to track the validation status and documents
- Proxy Approvals: Designated alternate approvers to expedite the approvals
- Task Reminder: Email alerts for the validation tasks
- Time bound Review and Approvals: Enforced time limits for the review and approval tasks.
- Web Access for Validation Tasks: Documents can be reviewed and approved virtually from anywhere.
- Electronic Storage: Electronic Storage removes the storage document space requirement.
- Instant release to production: Validated systems can be released in to production quickly by accessing the real time validation status.
- Eliminates the resource requirements for revalidation scheduling process by proving revalidation task alerts and collaborative calendar.
- Intangible Benefits: Intangible benefits of ValGenesis include consistent, compliant and efficient corporate validation process. Overall, ValGenesis reduces the risk of warning letters and recalls by FDA.
As an out-of-the-box solution, ValGenesis requires less overall implementation and validation time, and allows the information technology and validation experts within an organization to manage other projects simultaneously. By combining pre-configured ValGenesis application software with user requirements, templates and rapid implementation methodology, implementation of ValGenesis can be achieved in a very short period of time. The rapid implementation methodology not only provides faster service but it also affords a quicker return on investment (ROI), lesser total costs of ownership (TCO) for clients as well as gaining a critical competitive advantage.
Great Audit Trail Tool
The audit trail and Meta data associated with developed and executed documents in ValGenesis are designed to display in the form of reports for all the steps during the validation life cycle with associated electronic signatures, date and time stamps. Based on the corporate wide real time validation tracking, ValGenesis reduces the audit duration from a few days to a few hours. ValGenesis has several built in features designed to meet regulatory compliance requirements that withstand audit inspections. These features include audit trails for validation lifecycle, administrator audit trails for changes, security settings and user access permissions, compliant electronic signatures with date and time stamps, and a secured database to store documents and other validation related information.
Workflow Driven Revalidation Scheduler
In the current paper based manual system, managing an effective revalidation program to ensure that all critical GxP entities are revalidated on time is complex and difficult to maintain. Failing to revalidate critical GxP entities could result in FDA issued warning letters and citations.
With ValGenesis, complex revalidation schedules are managed by the application. The revalidation scheduler module is designed to alert user groups of any upcoming or delayed revalidation tasks ensuring that critical GxP entities are revalidated on time.
Revalidation scheduler in ValGenesis improves the lines of communication between the various departments through a configurable approval workflow and the revalidation schedule calendar. Approval of revalidation schedules with different groups helps to minimize the impact of the revalidation schedules on other regular activities including production.
Electronic Validation
In a paper-based process, document security is often challenged and quality often compromised. As a result, developed and executed documents can be misplaced or lost during the review and approval process. The nature of paper data ties it to one physical location, and distributing copies of data can be hard to track and secure. FDA encourages companies to move into an electronic system so as to improve the process and to enforce the consistency and quality. The Good Automated Manufacturing Practice Guide (GAMP), for testing of GxP systems states, “Computerized test management tools can significantly reduce the amount of paper used during testing and can provide helpful test management support. This includes the ability to report on the status of test activities and facilitate test activities by the use of workflow. In most large testing projects, the use of such a tool can reduce testing time scales.”
ValGenesis is the first product available in the market capable of conducting a test script execution electronically, achieving a 100% paperless validation process. Issues related to paper-based validation processes such as physically storing documents, manipulating executed documents, losing or misplacing executed test scripts, and scanning executed validation documents to an electronic format are completely eliminated with electronic execution. Executed test scripts are stored electronically in a secured central location for easy retrieval. In addition, ValGenesis improves communication between executors, reviewers and approvers of validation documents, plus spelling mistakes and illegible data entries during the execution are totally eliminated.
One of the most important features of ValGenesis and the executing of validation documents electronically is the fact that it is fully compliant with FDA regulations since the User ID and Time Stamps are captured for each test case row. ValGenesis enforces accountability during the entire execution process from task assignment to approvals. During the execution, screen shots or any supporting documents can be attached as hyperlinks at the test case row level. Plus, any number of files can be attached with each test case row. These attachments are available during the review and approval process as hyperlinks.
In addition, during the execution, the Witness function gives users the ability to ‘witness’ during the validation execution and can be enforced based on qualification requirements. Because the witness functionality is built into the ValGenesis system, it closely follows a paper-based process and allows for a second user to sign off, verifying the execution. The ability to adapt the witness requirement is completely configurable by the ValGenesis system administrator at the protocol level and can be adapted for specific GxP entities and/or qualifications.
Because ValGenesis provides end-to-end validation automation, from validation document number generation all the way to execution and deviation management, it turns the validation process into a 100% paperless and electronic system. The developed and executed documents are available with Meta data appended in the PDF format with 128-bit encryption.
Validation Deviations Workflow
During the electronic execution of a validation document, ValGenesis tracks all deviations that have occurred. Once a deviation is detected by the system, the deviation template will appear whereby the executor will assess and assign a severity level to the occurrence. The Initiator can review the deviations and route the deviations through a configurable workflow to approvers thereby allowing remedial action to be taken. When the deviation is initiated and routed for review and approval, the reviewers and approvers are notified as required through the Task Alert Feature and corporate email system. Essentially, ValGenesis greatly improves communication between the initiator, reviewers and approvers resulting in a more efficient execution process. |
