Cost and Time savings through ValGenesis -Validation Software Solution

PDA awarded ValGenesis the New Innovative Technology award for Paperless Validation Lifecycle Management Technology

Benefits of an Electronic Validation Lifecycle Management System

in the Corporate Validation Process – Validation Cycle Time and Cost Perspective

EVLMbenefits.indd 1 2/16/11 9:23 AM

Regulated Pharmaceutical, Biotech and Medical Device companies are challenged to develop manufacturing capabilities quickly and cost-effectively, while 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 the manual approach to validation. Over time the traditional validation activities have become centered on documentation, which has increased 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 using 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-to-market and introduce product quality problems that 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%

Benefits of an electronic Validation lifecycle ManageMent systeM in the corporate Validation process


# Current Process Impact of ValGenesis Efficiency Gain

1.1 Creating, reviewing and approving Validation plan and projects – 5% of the effort in the Validation Lifecycle Process

1.1.1 Validation Plans and projects are created manually and routed for review and approvals through inter-office mail.

Approved validation plans are available as reference but 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 are enforced in the process and eliminate the risk of noncompliance

Given these advantages of creating validation plans and projects in ValGenesis, it is expected to achieve a 20-30% efficiency gain in this area.

1.2 Authoring, reviewing and approving Validation protocols – 25% of the effort in the Validation Lifecycle Process

1.2.1 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 for, or replacing documents.

Furthermore, routing documents from one location to the next, adds additional delays. There will be a number of reviewers and approvers. Documents have to be routed to each reviewer, or approver, in a serial flow.

In ValGenesis authored documents are routed electronically and are available for review and approval in real time. ValGenesis supports routing in parallel, serial and a combination of parallel and serial (hybrid) reviews and approvals, to expedite the final approval process. Every document, its history and current status are available electronically ensuring solid and secure document control.

Parallel Review - Documents can be reviewed in parallel, whereby all reviewers can review documents at the same time.

Combination of Parallel and Serial 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 for example).

ValGenesis supports the reuse of requirements and developed protocols, through a binding process, for entities to be validated.

Given these advantages of authoring, reviewing and approving validation documents in ValGenesis, it is expected to achieve a 20-30% efficiency gain in this area.

1.2.2 In the current process, there is no method available to alert reviewers and approvers regarding target dates, or any delay in the process.

It is difficult to transfer the tasks to other reviewers and approvers, in the event of delay.

Alert Notification - Reviewers are alerted, in real time, of any waiting review or approval task, through corporate email.

1.2.3 Physical access to the document is required for review, or approval of the document.

Review or approval is delayed if the reviewer or approver is not available.

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 the Validation Lifecycle Process

1.3.1 Creating and maintaining a traceability matrix through a manual process is extremely time consuming. The traces between requirements and test cases are generally buried in the paper and cannot provide any real time information, or impact assessment.

Traceability Matrices can be created dynamically within few mouse clicks in ValGenesis. The Traceability Matrix function within ValGenesis improves change management by providing an 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 trace between requirements, design elements and test cases.

Given these advantages of creating and maintaining requirements and traceability matrices in ValGenesis, it is expected to achieve a 40-50% efficiency gain in this area.

1.3.2 Developing requirements takes significant effort and coordination between all users.

Requirements are subject to frequent changes and version control should be adopted. It is time-consuming and difficult to maintain requirements in the paper-based process

ValGenesis provides a collaborative approach to effectively communicate with all users, through a requirements bulletin board, reducing the time to complete the requirement gathering process.

ValGenesis provides the functionality to maintain the requirements, with version control. This approach provides much more control and significantly reduces the time to maintain the requirements.




1.4 Executing, reviewing and approving Validation protocols – 25% of the effort in the Validation Lifecycle Process

1.4.1 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 also be attachments to the executed document.

Documents are executed electronically and screen shots are attached at the test case row level. Files can also be attached at the row level.

Given these advantages of executing, revising and approving validation documents in ValGenesis, it is expected to achieve a 40-50% efficiency gain in this area.

1.4.2 Deviations or exceptions are handled manually through paper-based documents. Each deviation will be handled through a separate time-consuming paper-based workflow.

Deviations are handled electronically and the deviation workflows are concurrent for any number of deviations, this will expedite the execution process.

1.4.3 Hand-writing can be difficult to read and may contain typographical errors

ValGenesis provides spell-checking and all content is electronic and easy to read.

1.4.5 Once the document has been executed it must be physically sent to the reviewers or approvers, through inter-office mail, or other delivery options.

Furthermore, routing documents from one location to the next adds additional delays. There will be a number of reviewers and approvers. The documents have to be routed to one reviewer or approver in a serial flow.

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 (hybrid) review and approval, to expedite the process.

Parallel Review – Executed documents can be reviewed in parallel; whereby all reviewers can review the document at the same time.

Combination of Parallel and Serial 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 for example).

ValGenesis supports the reuse of requirements and developed protocols, through a binding process with other entities, to be validated.

1.4.6 There is no automated method to alert reviewers and approvers regarding target dates, or delays in the process.

It is difficult to transfer the tasks to other reviewers or approvers, in the event of a delay.

Alert Notification - Reviewers are alerted in real time of any review or approval task, through corporate email.

Tasks may be transferred to other reviewers and approvers automatically should there be a delay

Management is notified of delays and can take any necessary action.

1.4.7 Physical access to the executed document is required for review, or approval.. Review or approval is delayed if a reviewer or approver is not available.

No physical access is required; documents can be approved through secure corporate networks.

1.4.8 There is great potential to misplace or lose executed document during transfers

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 the Validation Lifecycle Process

1.5.1 Risk assessment is manual and again generally paper-based; this requires information from a number of different systems, or departments. This is a time-consuming and error-prone process.

ValGenesis brings together all the impacts associated with the validated systems/entities for assessment. For example, the associated change requests, upcoming revalidation/periodic review etc. are pulled together. This means all the impacts can be brought together in fewer documents electronically.

Given these advantages of managing the risks in ValGenesis, it is expected to achieve a 40-50% efficiency gain in this area.

1.5.2 Approval of risk assessment is generally managed through manual and paper-based processes, it is extremely time-consuming.

ValGenesis provides comprehensive workflow capabilities to manage the risk assessment.

1.5.3 There are no automated alerts for SMEs should there be any impact on the validation status of systems/entities.

ValGenesis automatically alerts SMEs if there is any impact.




1.6 Create and maintain periodic review and revalidation schedules – 5% of the effort in the Validation Lifecycle Process

1.6.1 Periodic review and revalidation schedules are maintained in paper. It is very time-consuming and error-prone.

ValGenesis provides a dynamic validation calendar for upcoming and delayed periodic reviews and revalidations

Given these advantages of maintaining periodic review and revalidation schedules in ValGenesis, it is expected to achieve a 40-50% efficiency gain in this area.

1.6.2 Periodic review and revalidation schedules are generally approved through a paper-based process.

Workflow-driven review and approval for Periodic review and revalidation schedules.

1.6.3 No automatic alerts for upcoming, or delayed, revalidation or periodic review schedules.

ValGenesis provides automatic alerts for upcoming and delayed periodic reviews and revalidations; this helps to eliminate the possibility of missing a validation task due to human-error.

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 the validation lifecycle.

2.1 Tracking the validation status for decision-making 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%


2.1. Tracking the validation status for decision-making

2.1.1 In a paper-based system, tracking is difficult at best, as it often requires e-mails, or phone calls, to prospective reviewers, approvers, and document specialists.

ValGenesis is equipped with built-in tracking functions, designed to enable 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.

Given these advantages of real time tracking functions in ValGenesis, it is expected to achieve a 70-80% efficiency gain in this area.

2.2 Audit preparation for internal and external audits

2.2.1 With paper-based systems, audit preparation is much more cumbersome, given that documents must be located in a physical document repository. Furthermore, when documents are not available, there is additional delay in 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 users can be prepared for audits with very little effort finding documents in a few mouse clicks.

Given these advantages of audit readiness through ValGenesis, it is expected to achieve a 80-90% efficiency gain in this area.

2.3 Document retrieval

2.3.1 Documents have to be searched and retrieved from a physical document storage location. This method has a high cost of maintenance and needs extra resources.

Documents can be retrieved in real time. Documents are available electronically in real time. There is no need for physical document storage and the resources to manage them.

Given these advantages of ValGenesis, in terms of document availability and retrieval, it is expected to achieve a 70-80% efficiency gain in this area.



Contact Information:

47102 Mission Falls Court | Ste 218, Fremont, CA 94539Phone: 1-888-825-4363 & (510) 445-0505 | Fax: (510) 991-9901

www.valgenesis.com | Email: [email protected]

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 cycle for any entity. In fact, the costs associated with traditional paper-based validation, represent approximately one-third of the total resources required for overall implementation. With the traditional manual validation processes, the costs also include significant amounts of review and approval time, for developed and executed documents, as well as the time to manage results and track the validation status and protocols. Unfortunately, these high costs can stifle innovation in life science companies, and compromise the ability to bring new products to market efficiently.

ValGenesis is designed to manage the entire Validation life cycle electronically and remove the inefficiencies that plague paper-based processes; ValGenesis helps to reduce the cost of validation, allowing optimization and stabilization of existing processes, plus electronic management (document authoring, test execution, review and approval) of validation processes and procedures. This reduces the cost of the validation process by eliminating much of the paper-based documentation and process/procedure approvals. ValGenesis is expected to reduce the cost and time of Validation Lifecycle process by 30-40%, when the system is configured to meet specific validation process flows and adequate training for users.


2.4 Validation metrics for resource and budget planning

2.4.1 No metrics available in the paper-based system, difficult to control costs and estimate budgets.

ValGenesis provides metrics for budgeted vs. actual results, allowing efficient planning and cost control.

Given these advantages of the real time metrics functionality in ValGenesis, it is expected to achieve a 50-60 % efficiency gain in this area.

2.4.2 No mechanism to track the performance of the individuals involved in the validation process, based on their contribution.

ValGenesis can track the performance of individual users within the system.


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.
