Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process Validation Cycle Time and Cost Perspective

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1 Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process Validation Cycle Time and Cost Perspective PDA awarded ValGenesis the New Innovative Technology award for Paperless Validation Lifecycle Management Technology

2 Regulated Pharmaceutical, Biotech and Medical Device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety. Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation. Over time the traditional validation activities have become centered on documentation, which has increased tremendously and led to additional quality issues. For the most part, validation still requires a high degree of manual effort for tracking and reporting, and the execution of most validation protocols takes place on paper. Traditional validation activities, with paper-based validation processes, stifle innovation, cause compliance risks and compromise a life science firm s ability to bring products to the market on time. Inefficiencies in the validation process cost regulated manufacturers millions of dollars annually, mainly attributed to the use of paper, or paper/hybrid electronic systems. These manual, or hybrid, labor-intensive systems are proven to be error prone, delay time-tomarket and introduce product quality problems that can risk stringent regulatory penalties. Validation lifecycle activities are separated into the following two major categories for efficiency estimation, 1. Core Validation activities 2. Supporting Validation activities 1.0 Core Validation activities: Core validation activities constitute 80% of the overall Validation Lifecycle. The following are the core validation constituents and the associated effort required for the validation lifecycle. 1.1 Creating, reviewing and approving Validation plans and projects 5% 1.2 Authoring, reviewing and approving Validation protocols 25% 1.3 Creating and maintaining traceability matrices and requirements 10% 1.4 Executing, reviewing and approving Validation protocols 25% 1.5 Risk assessment, review approval and maintaining the validation status -10% 1.6 Creating and maintaining periodic review and revalidation schedules 5% Validation Plan Risk Assessment Monitor and Assess Risk Factors Create Validation Plans and Projects TEST CASE Authoring Document Development Validation Scheduler Manage Periodic Review and Revalidation Schedules Manage Change Control Process Change Management TEST EXECUTION, DEVIATION MANAGEMENT Manage Requirements, Dynamic Trace Matrices Test Execution Requirements Trace Matrix

3 1.1 Creating, reviewing and approving Validation plan and projects 5% of the effort in Validation Lifecycle Process Validation Plans and projects are created manually and routed for review and approvals through inter-office mail. Approved validation plans are available as reference and cannot be enforced in the process. Validation plans and projects can be developed electronically and routed for review and approval through workflow. Approved Validation plan and requirements can be enforced in the process and eliminates the risk of noncompliance 1.2 Authoring, reviewing and approving Validation protocols 25% of the effort in Validation Lifecycle Process In a paper environment, once a document has been authored or executed it must be physically sent to the corresponding reviewers or approvers through inter-office mail or other delivery options. Paper documents can be misplaced or lost causing time to be spent searching or replacing documents. Furthermore, routing documents from one location to the next adds additional delays. There will be few reviewers and approvers. The documents have to be routed through to one reviewer or approver at any given time in a serial flow There is no way to alert the reviewers and approvers through an automated method regarding target dates or delays in the process. It is difficult to transfer the tasks to different reviewer and approver in the event of delay Physical access to the document is required to review or approve the document. Review or approval gets delayed if the reviewer or approver is actually present. In ValGenesis; authored documents are routed electronically and are available for review and approval in real time. ValGenesis supports parallel, serial and hybrid workflows for reviews and approvals to expedite the final approval process. Every document, its history and its current status are available electronically ensuring document control. Parallel Review - Documents can be reviewed in parallel, whereby all reviewers can review the document at the same time. Hybrid Review: Documents can be reviewed in parallel by the first few reviewers and approvers, the final approval can be done in serial (one QA Approver). Alert Notification - Reviewers are alerted in real time of any review or approval task through corporate . No Physical access is required; documents can be sent securely through corporate networks. 1.3 Creating and maintaining traceability matrices and requirements 10% of the effort in Validation Lifecycle Process Creating and maintaining traceability matrices through a manual process is a time consuming task. The traceability between the requirements and test cases are buried in the paper and do not provide any real time information or impact assessment Developing requirements takes significant time having to coordinate with all the users. Requirements are subject to frequent change and version control should be adopted. It is time consuming and difficult to maintain the requirements in the paper-based process The Traceability Matrix function within ValGenesis improves change management by providing accurate assessment of its impact by identifying related requirements, design elements, and test scripts. In addition, it helps to scope the regression testing clearly and accurately. During test case execution, the deviations observed in a test case can be tracked and traced back to the associated design elements in the Traceability Matrix. During audits and inspections, the Traceability Matrix provides a clear, real-time view of the required documents, in addition to observing all supporting documentation for any given operation. During audits and inspections, the Traceability Matrix provides a clear, real-time view of the required documents, in addition to observing all supporting documentation for any given operation. ValGenesis provides the collaboration function to bring all the users together through a requirements bulletin board, effectively reducing the time to complete the requirement gathering process. ValGenesis provides the collaboration function to bring all the users together through a requirements bulletin board, effectively reducing the time to complete the requirement gathering process. creating validation plans and projects in ValGenesis, it is expected to achieve a 20-30% efficiency authoring, reviewing and approving validation documents a 20-30% efficiency creating and maintaining requirements and traceability matrices

4 1.4 Executing, reviewing and approving Validation protocols 25% of the effort in Validation Lifecycle Process Documents have to be executed manually with pen and paper. Screen shots have to print through a printer and attached with the executed document as attachments. Supporting files, such as reports, will be attachments to the executed document Deviations or exceptions are handled manually through paper documents. Each deviation will be handled through a separate time consuming paper-based workflow Hand-writing can be difficult to read and may contain typographical errors Once the document has been executed it must be physically sent to the corresponding reviewers or approvers through inter-office mail or through other delivery options. Furthermore, routing documents from one location to the next adds additional delays. There will be few reviewers and approvers. The documents have to be routed through to one reviewer or approver at any given time in a serial flow There is no way to alert the reviewers and approvers through an automated method regarding target dates or delays in the process. It is difficult to transfer the tasks to different reviewer and approver in the event of delay Physical access to the executed document is required to review or approve the document. Review or approval gets delayed if the reviewer or approver is not physically present There is potential to misplace or lose the executed document during transfers Document is executed electronically and screen shots are attached at the test case row level. Files can be attached at the row level. Deviations are handled electronically and the deviation workflows are concurrent for any number of deviations, this will expedite the execution process. ValGenesis provides spell checking and all content is electronic and easy to read. In ValGenesis executed documents are routed electronically and are available for review and approval in real time. ValGenesis supports parallel, serial and combination of parallel and serial review and approvals to expedite the final approval process. Parallel Review Executed documents can be reviewed in parallel whereby all the reviewers can review the document at the same time. Hybrid Review: Executed documents can be reviewed in parallel by the first few reviewers and approvers, the final approval can be done in serial (one QA Approver). ValGenesis supports the reuse of requirements and developed protocols through a binding process to other entities to be validated. Alert Notification - Reviewers are alerted in real time of any review or approval task through corporate . Tasks may be transferred to other reviewers and approvers automatically in the event of delay Management can be notified of delays and take action to remove barriers. No Physical access is required; documents can be approved through secure corporate networks. Documents are available in electronic format and are stored centrally for easy access. 1.5 Risk assessment, review, approve and maintain the validation status - 10% of the effort in Validation Lifecycle Process Risk assessment is done manually; this requires information from various resources. This is a time consuming and error prone process Approval of risk assessment is done through manual and paper-based processes, it is time consuming There are no alerts for SMEs if there is any impact on the validation status of systems/ entities. ValGenesis brings all the impacts associated with the validated systems/entities together for assessment. For example, associated change requests, upcoming revalidation/periodic review etc. are pulled in together to develop fewer documents by bringing these impacts together. ValGenesis provides comprehensive workflow to manage the risk assessment. ValGenesis alerts the SMEs if there is any impact on the validated status of the system/entity. executing, revising and approving validation documents managing the risks

5 1.6 Create and maintain periodic review and revalidation schedules 5% of the effort in Validation Lifecycle Process Periodic review and revalidation schedules are maintained in paper. It is time consuming and error prone Periodic review and revalidation schedules are approved through paper-based process No alerts for upcoming or delayed revalidation or periodic review schedules. ValGenesis provides a dynamic validation calendar for upcoming and delayed periodic reviews and revalidations Workflow-driven review and approval for Periodic review and revalidation schedules. ValGenesis provides alerts for upcoming and delayed periodic reviews and revalidations; this helps to eliminate the possibility of missing a validation task due to human error. maintaining periodic review and revalidation schedules 2. Supporting Validation Activities: Supporting validation activities consist of 20% of the overall Validation Lifecycle. The following are the supporting validation activities and associated effort required in validation lifecycle. 2.1 Tracking the validation status - 10% 2.2 Audit preparation for internal and external audits 3% 2.3 Document retrieval 2% 2.4 Validation metrics for resource and budget planning 5% # Current Process Impact of ValGenesis Efficiency Gain 2.1. Tracking the validation status - 10% of the effort in Validation Lifecycle Process In a paper-based system, tracking is difficult at best, as it often requires s or phone calls to prospective reviewers, approvers, and document specialists. ValGenesis is equipped with built in tracking functions designed to allow users to locate an authored or executed document easily and in real time. These functions include development and execution pie charts from the dashboard, inventory manager with search capabilities, barcode scanning from the production floor, and transparent audit trails available to any user involved with developing, execution, reviewing, or approving any document. 2.2 Audit preparation for internal and external audits - 3% of the effort in Validation Lifecycle Process With paper systems, audit preparation is much more cumbersome given that documents must be located from a physical document repository. Furthermore, when documents are not available from a document repository that exists locally, there is an additional delay associated with physically routing the document to the intended receiver. All documents are generated electronically in ValGenesis and can be retrieved from the system s electronic repository (Library) in real time. This means that users are always prepared for audits with little effort required and documents are available within a few mouse clicks. 2.3 Document retrieval 2 % of the effort in Validation Lifecycle Process Documents have to be searched and retrieved from the physical document storage location. Physical document storage requires cost of maintaining the storage location and resources. Documents can be retrieved in real time. No longer required to search for documents in a document repository. There is no need to for physical document storage and resources to manage them. real time tracking functions a 70-80% efficiency audit readiness through ValGenesis, it is a 80-90% efficiency ValGenesis in terms document availability and retrieval, it is a 70-80% efficiency

6 2.4 Validation metrics for resource and budget planning - 5% of the effort in Validation Lifecycle Process No metrics available in the paper- based system, difficult to control the cost and estimate the budget There is no mechanism to track the performance of the individuals involved in the validation process based on their contribution. ValGenesis provides metrics for budgeted vs. actual results for efficient planning and cost control. ValGenesis helps to track the performance of individual users within the system. real time metrics functions in ValGenesis, it is expected to achieve a % efficiency 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 the 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 innovation, and compromise the ability to bring new products to market. ValGenesis is designed to manage the entire Validation life cycle electronically and remove the inefficiencies that plague paper-based processes; ValGenesis reduces the cost of the validation process by allowing optimization and stabilization of existing processes, plus electronic management (document authoring, test execution, review and approval) of validation process and procedures. This will reduce the cost of the validation process by eliminating much of the paperbased documentation and process/procedure approvals. ValGenesis is expected to reduce the cost and time of Validation Lifecycle process by at least 30-40%, if the system is configured to meet your specific validation process flow with adequate training for the users. Copyright 2009, ValGenesis inc.. All rights reserved. This document is provided for information purposes only and the contents hereof are subject to change without notice. This document is not warranted to be error-free, nor subject to any other warranties or conditions, whether expressed orally or implied in law, including implied warranties and conditions of merchantability or fitness for a particular purpose. We specially disclaim any liability with respect to this document and no contractual obligations are formed either directly or indirectly by this document. This document may not be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without our prior written permission. ValGenesis is a registered trademark of ValGenesis Inc. and/or its affiliates. Other names may be trademarks of their respective owners. Contact Information: Mission Falls Court Ste 218, Fremont, CA Phone: & (510) Fax: (510) info@valgenesis.com