Top Ten Reasons to

Implement ValGenesis
Significant Functions and
Features of ValGenesis

ValGenesis White Paper

January 2007
Table of Contents

Overview .......................................................................................................................................3

Benefit 1: Track the Validation Status in Real Time....................................................................... 4

Benefit 2: Enforce Consistency in the Validation Process.............................................................. 6
Benefit 3: Reduce the Validation Cycle Time.................................................................................. 6
Benefit 4: Electronic Execution of Test Cases................................................................................ 7
Benefit 5: Manage Test Case Deviations through Controlled Workflow........................................ 8
Benefit 6: Great Audit Trail Tool for Internal and FDA Audits........................................................ 9
Benefit 7: Workflow Driven Periodic Review/Revalidation Schedules.......................................... 9
Benefit 8: Availability of Electronic Validation Data and Documents........................................... 9
Benefit 9: Stay in Compliance...................................................................................................... 10
Benefit 10: Reduce the Cost of Validation Process...................................................................... 10

Conclusion.................................................................................................................................. 12
Overview
Top Ten Reasons That ValGenesis Ensures Success!
Making a Strong Impact on the Corporate Validation Process

It has been said that without change there is no progress nor are there incentives for improvement. For that reason, change is
a necessary component in the business world as it generally inspires greater efficiency and more advanced business ideas.

Validation has been an essential part of FDA-regulated industries for over 20 years, yet as the field has evolved, little has
changed about the business process of validation. 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. By and large, predominantly paper
and manual based validation processes stifle innovation, cause compliance risk and compromise a life science firm’s ability
to bring products to the market on time. Plus, with the increased use of computers along with the progression of evolving
software technology, a more advanced validation solution has become essential to the life sciences industry.

Evolving Software Technology from ValGenesis

In reality, bringing products to market in a timely fashion using paper-based validation is nearly impossible. And since paper
based validation process has become outdated, inefficient, time consuming, resource intensive and costly to manage, Val-
Genesis is an innovation that replaces inefficient paper based documentation with a more advanced electronic based system.
In short, ValGenesis is a far more effective software solution that enhances corporate validation processes and assures the
removal of any deficiencies inherent to paper based documents.

Unique Tool Automates Corporate Validation Process

As a core resource for compliance-based validation in regulated companies, ValGenesis is in the forefront of innovative soft-
ware platforms with far-reaching results that provide end-to-end validation automation. Seeing that ValGenesis expedites
the validation process and removes the inefficiencies that plague paper-based processes, implementing ValGenesis, is a
wise business choice. In that it allows companies to save up to 30-40% in time and money, ValGenesis not only removes the
physical secured document storage space requirement, but it also eliminates the time requirement for tracking the validation
status. In brief, ValGenesis reduces the audit duration from a few days to just a few hours, improves the efficiency of the
entire validation process, enhances quality and consistency, provides a line of defense against internal or FDA audits and
reduces the costs of validating entities.

Ensures and Enforces Compliance and Consistency

ValGenesis’s unique technology automates the validation process, dynamically tracking validation status in real time, stream-
lining the process, improving communication across the board between all stakeholders, and ensuring/enforcing compliance
and consistency throughout the entire corporate validation process. Fully modularized with elements for tracking, devel-
opment, execution, revalidation schedules and content management, ValGenesis compliments any existing framework and
closely matches the well-established paper process. In brief, ValGenesis does it all, except that it does it electronically with
a reduction in the validation cycle time frame along with less cost for validation.

Top Ten Reasons ValGenesis Assures Success

The benefits associated with the implementation of the ValGenesis system are many and results are quickly obvious. To dem-
onstrate the advantages of ValGenesis, the following explains in detail the top ten benefits associated with ValGenesis and
explains how ValGenesis makes a strong impact on the validation process.

3
 Benefit 1: Track the 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 valida-
tion status of any entity (system, instrument, equipment etc.) corporate wide.

• Tracking the Validation Status with Inventory Report Manager

ValGenesis is designed with a drill down Inventory Report Manager that allows for the tracking of the validation status on any
entity that is registered in the system. The Inventory Report Manager stores entities in a user-friendly tree hierarchy for sim-
plified navigation. Similar entities can be grouped into sub categories, while similar sub categories can be grouped under one
category. ValGenesis does not restrict the number of categories, sub categories or entities. Below, in Figure 1 is an example
of the Inventory Report Manager.

Fig. 1: Inventory Report Manager

As demonstrated, the Inventory Report Manager saves a significant amount of time that would otherwise be spent tracking the valida-
tion status of an entity. In ValGenesis, an entity can be located in just a few mouse clicks complete with details outlining the validation
status along with User ID and Time Stamps captured for each associated activity, including development, execution review, approval
etc. Figure 2, found below is an example of the Meta data associated with the development and execution of a validation document
that is generated by ValGenesis and viewed through the Inventory Report Manager.

4
 Fig. 2: Validation Document Report

• 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, as shown in Fig.3, users with an appropriate role can view the validation document status
of any entity regis¬tered in the system in real time. The dashboard feature is designed with pie charts with each pie chart subdivided
into sections that provide a more granular look at either the development or execution stages.

The drill down dashboard provides a complete au-

dit trail with each activity captured during review
and approval workflows complete with user ID and
time stamps. This provides a valuable decision sup-
port tool for allocating human resources, maximiz-
ing validation team efforts, and locating the cause
of any delays.

Fig. 3: Dash Board

5
• Tracking Validation Status with Barcode
Another important tracking feature built into ValGenesis is the barcode feature that allows for the generating of unique bar
codes for each entity registered in the system. The bar code feature is a tremendous aide for a number of reasons. As the bar
codes are printable, they can be physically attached to the entity and used for identifying validation details of an entity simply
by scanning. When scanning an entity on the production floor, users can determine the real time validation status of the entity
during an audit. This significantly reduces the time currently spent on retrieving documents from a document repository and
provides assurance to withstand scrutiny by any internal, FDA 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.

Benefit 2: Enforce Consistency in the Validation Process

One of the primary challenges in the paper based validation process is maintaining the consistency of the validation docu-
ments. 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 compli-
ance—might not want several consultants 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 entity related information such as model numbers, version numbers, etc., in the validation documents. Often these
requirements are overlooked and may lead to non-compliance.

• Enforce Consistencies through Templates

In ValGenesis validation consistency is enforced through the use of validation document templates. Any number of valida-
tion templates can be registered in ValGenesis and bound to specific validation document types such as DQ, IQ, OQ, PQ, CQ
etc. Once a template is registered in ValGenesis and bound with specific validation document types, validation engineers or
consultants responsible for developing the validation documents must use the configured template. This leads to validation
document consistency and enforces compliance in the validation process. In addition, when creating a validation document
template, headers and footers are attached to the template with tags for version number, model number, etc. During the de-
velopment and execution, the document will be populated with entity related information such as a model number, version
number, etc., from the database. As with the template creation, header and footer templates are configurable and easy to
create. Consistency in the validation process can be enforced across the site/company for use with the same template for
the specific validation task. ValGenesis uses word templates and captures the Meta data associated with the entities, which
are populated in the header and footer of the documents.

Benefit 3: Reduce the 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 through the Task Alert Feature as well as through corporate email. Once the document is developed and
submitted, reviewers and approvers are notified through both the Task Alert Feature and corporate email system. Essentially,
ValGenesis improves the communication between assigners, developers, reviewers and approvers resulting in a more efficient
document development process.

• Time Bound Review Workflow

The review function created for document development and execution provides the user with the ability to route the docu-
ment 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 the ability to view all comments pertaining to the document
allows true collaboration as well as increased document quality. Once the review period has ended and each of the reviewers

6
has confirmed review of the document, the developer is able to assess all comments, making any required changes before
routing the document for approval.

• Approval Workflow with Proxy Approvers

Approving validation documents in ValGenesis is accomplished in a genuinely collaborative manner whereby each approver in
the approval workflow has the ability to comment on the document and reroute it to the developer for revision. As ValGenesis
is equipped with controlled and configurable approval workflows complete with a proxy approval option, the proxy approval
option eliminates delays associated with paper-based approval workflows, which include approvers failing to complete ap-
proval tasks. 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. Each time a document is routed back to the original developer
for revision, ValGenesis forces the developer to assign a new version number to the document. Once the changes have been
accepted and/or rejected, the validation document is rerouted through the approval workflow.

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. Each time an
approval task awaits a response from the designated approver, a message is sent through the Task Alert Feature as well as the
corporate email system ensuring that the approver is notified immediately of the approval task. Electronic signatures available
with ValGenesis can be configured to follow the corporate specific chain of custody requirements and to enforce validation
procedures and requirements.

Benefit 4: Electronic Execution of Test Cases

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, review-
ers 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.

Benefit 5: Manage Test Case Deviations Through Controlled Workflow

During the electronic execution of a validation document, ValGenesis tracks all deviations that have occurred. Once a devia-
tion 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 ex-
ecution process. Below, in Figure 4 is the Test Script Deviation Template.
7
 Fig. 4: Test Script Deviation Template

Benefit 6: Great Audit Trail Tool for Internal and FDA Audits
ValGenesis has several built in features designed to meet FDA compliance requirements that withstand audit inspections.
These features include audit trails for documents, administrator audit trails for changes, security settings and user access
permissions, compliant electronic signatures with date and time stamps, and a secure database to store documents and other
validation related information. The audit trails for approved and executed documents in ValGenesis are designed to display a
report of the various steps during document completion 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.

Benefit 7: Workflow Driven Periodic Review/Revalidation Schedules

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 is-
sued warning letters and citations.

With ValGenesis, complex revalidation schedules are managed by the application. The revalidation scheduler module is de-
signed to alert user groups of any upcoming or delayed revalidation tasks ensuring that critical GxP entities are revalidated on
time. Once a revalidation schedule has been defined and approved, the schedule is automatically written to the revalidation
schedule calendar and user groups are automatically alerted of any upcoming or delayed revalidation tasks through email

Revalidation scheduler in ValGenesis improves the lines of communication between the various departments through a con-
figurable 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.

8
Benefit 8: Availability of Electronic Validation Data and Documents
ValGenesis is built on an open architecture to easily integrate with other quality systems including change management,
deviation, ERP and document management systems so as to have effective bi-directional data flow. 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. 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.

The Good Automated Manufacturing Practice Guide (GAMP), for testing of GxP systems states, “Computerized test manage-
ment tools can significantly reduce the amount of paper used during testing and can provide helpful test management sup-
port. This includes the ability to report on the status of test activities and facilitate test activities by the use of work-
flow. In most large testing projects, the use of such a tool can reduce testing time scales.” Implementing ValGenesis
validation management system offers significant value, as it is easy to locate, plus different users with different roles
in different locations can be given secure and non-exclusive access with complete audit trail and traceability.

Benefit 9: 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 in-
spections, 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 entity information including model numbers, version numbers, etc., from the database as configured.
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. During
the execution, user ID and time stamps are captured at each row and screen shots on any supporting documents can be added
at each row to quantify the execution, thereby meeting the stringent compliance requirements. Spelling mistakes and typos
are also captured and can be corrected along with a reason for the change with User ID and time stamp. 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.

Benefit 10: Reduce the Time and Cost of Validation Process

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 as-
sociated 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 valida-
tion 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.
9
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 infor-
mation 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.

10
In Conclusion

As an intuitive, user-friendly application, ValGenesis is most assuredly a tool that can be configured
to enforce any specific business rules that meet and comply with the validation process. Though many
life science organizations are cautious about implementing automation technologies in FDA-regulated
environments, many others are discovering that these tools actually help to reduce compliance uncer-
tainty as well as decreasing cost of validation. As validation has become very important to the success
and survival of companies, automation has proven to greatly streamline operations. In effect, properly
deployed automation technology actually lowers compliance risk, thereby making the validation pro-
cess far more efficient. Once configured, very little training is required, therefore companies can quickly
benefit from the advantages offered by ValGenesis and immediately begin realizing a significant ROI.

11
 43136 Christy St., Suite 100 • Fremont, CA, 94538
Phone: (888) 546-7797 • Fax: (510) 991-9901
Email: info@valgenesis.com • www.valgenesis.com

Issue No.: 02 Publication

Ref.: VG/11/07
Date of Publication: January 2007

© 2004. ValGenesis Inc., All rights reserved. Microsoft Windows and Microsoft Windows, NT and 2000 are trademarks or registered trademarks of the Microsoft Corporation in the United States and/or
other countries. Oracle is a registered trademark of The Oracle Corporation