The document discusses the challenges of traditional paper-based equipment validation processes, including lack of visibility, inability to track changes, and inconsistent documentation. It introduces ValGenesis Validation Lifecycle Management System (VLMS) as a 100% paperless solution that automates the entire validation process and addresses the challenges of paper-based systems. ValGenesis provides real-time transparency, access to critical data, consistency through templates, and other capabilities to improve the efficiency and management of equipment validation.

1. ValGenesis - Validation Lifecycle Management System
(VLMS) is a 100% paperless solution which provides
users the ability to fully automate an equipment
validation process including protocol execution.
ValGenesis removes the non-value added manual
activities and inefficiencies that plague paper-based
equipment validation process.
In the traditional paper based validation process there are
many challenges that directly impact the quality, consistency,
and efficiency of an organization's validation program
resulting in overall higher costs and longer cycle time. Some
of these challenges include: a lack of visibility throughout
the validation process, inability to effectively manage
changes to specifications and requirements, and
inconsistency in documentation and validation practices.
With a paper based process, there is a lack of transparency
throughout the equipment validation lifecycle. The ability to
track the status of validation deliverables in real time is not
possible. Tracking this information in real time is only
possible through direct interaction with users involved with
the document lifecycle. This includes phone calls, emails, and
at times physically walking the document from one person to
the next.
Challenges with Traditional Equipment Validation
Along with document tracking issues, in a paper based validation
process, it is extremely difficult to determine the validation state
of equipment. The reason for this is that critical data, which
impacts the validation state is scattered across different paper
records and systems. When this critical data is not readily
accessible, it is cumbersome to efficiently and effectively
determine the impact of changes to the validated state of
equipment.
In addition to the problems previously noted, managing changes
to specifications and requirements is difficult in the traditional
paper based equipment validation process. Typically, equipment
specifications and requirements are not maintained effectively
nor are they kept current. This has a direct impact with regards
to determining the validation state. When assessing the impact
of a change to specifications or requirements, key information,
which is necessary for making decisions, is not readily accessible.
Furthermore, management of change is often completed in
different quality systems, which is not integrated with the
equipment validation lifecycle
A paper based equipment validation process is inconsistent. The
problem with inconsistent documentation is that the degree of
validation and the quality of test cases will differ from one user
to the next. Furthermore, the format and general look and feel
of documents will be different.
.
Lastly, paper based equipment
validation is inefficient. Documents must be routed physically
from person to person and signed off with a wet signature. If
those involved with the reviews and approvals of any documents
Efficient Equipment Validation Lifecycle Process through ValGenesis VLMS
PAPERLESS EQUIPMENT VALIDATION
VALGENESIS

2. PAPERLESS EQUIPMENT VALIDATION
Paperless Validation Lifecycle Management with ValGenesis
2
ValGenesis is a validation lifecycle management system, which
provides organizations with the ability to fully automate the
equipment validation lifecycle process. ValGenesis manages the
validation process from the initial validation plan creation,
requirement and test script authoring, to electronic executions of test
cases, managing changes through a controlled change control process
and scheduling periodic reviews to maintain the validation status. The
system has been designed to provide organizations with the tools to
enforce standard operating procedures without any additional
overhead to the process. The solution is 100% paperless ensuring that
data is easily accessed and information can be retrieved in real time.
How Does ValGenesis Improve your Validation?
ValGenesis provides several different mechanisms within the application to improve the efficiency of an organization's validation
process. The challenges associated with paper based processes are minimized or completely eliminated through ValGenesis
VLMS. Below is a description of each issue with paper based processes and how ValGenesis VLMS is able to mitigate these issues.
Transparency
ValGenesis VLMS provides complete visibility throughout the validation lifecycle. The system provides several different
mechanisms, which enable users to quickly locate documents and view them in real-time in the current state of
validation of any equipment. ValGenesis is equipped with an Inventory dashboard, which is designed to allow users to
view the state of validation in real-time for any equipment.
The Inventory dashboard provides a comprehensive view of any equipment. The system will display all of the documents that
have been created for the equipment, change request related to the equipment, and illustrate what the validation
requirements are for the equipment to determine the validation state. Within the Inventory dashboard, users have the ability
to drilldown and view document audit trails for each document that has been created. The document audit trails provide real-
time information including where the document comes from, where it is now, and where it is going next. ValGenesis provides
users with the ability to view both the comprehensive audit trail and a flowchart that depicts the defined workflow.
Example Change Controls Associated with Equipment
are located in different locations, the problems associated to routing the documents are compounded. Also, paper based reviews
do not provide reviewers with the ability to rightly collaborate during the review process. Each reviewer will only be able to view
those comments or changes by the previous reviewers. The challenges related to a paper based equipment validation lifecycle
result in lengthier validation lifecycles and overall higher validation costs. Highly skilled technical resources spend a significant
amount of time managing non-value added activities including printing, scanning, routing, tracking and storing documents.
Example Flowchart for a WorkflowExample Inventory Manager
Mike
Manager
Eric
Engineer[er]
EQ Group
Quality
Assurance
Route
Margaret
Manager[marge]
Engineers
Quan
Quality[quan]

3. 3
Real-Time Access to Critical Data
ValGenesis provides real-time access to critical data. This in turn provides end users with the necessary information to assess the
impact of changes to specifications and requirements. Once a change has been assessed, ValGenesis provides users with the
flexibility to manage the change control process and documentation requirements within the application or just manage the
documentation. The ability to review all pertinent information in relation to any equipment sets ValGenesis VLMS apart from the
paper based process. Along with providing real-time access to critical data during a change control process, ValGenesis also
bridges the gap between change control and validation. In ValGenesis, validation deliverable requirements triggered by any
change are maintained along with the change. This means that the system can be configured to ensure that all documentation is
complete prior to the closure of any change.
Determining Validation State
ValGenesis is equipped with a unique function, which enables users to define the validation deliverable requirements for any
equipment to be considered as validated and therefore to determine the validation state. This unique function is referred to as the
validation framework. Validation frameworks provide organizations with the ability to enforce consistency in a validation process
by ensuring that the appropriate level of validation is completed for equipment. The system enforces validation consistency by
utilizing decision trees, which can be associated with the validation framework. Decision trees provide organizations with the
ability to create a series of questions, which determine document deliverable requirements. When assessing equipment, users
simply answer questions from the decision tree and ValGenesis automatically identifies the validation requirements such as
validation master plan, user requirement specifications, operational qualifications, etc. ValGenesis automatically determines the
validation state for equipment based on the deliverable requirements identified within the validation framework and approved
deliverables.
PAPERLESS EQUIPMENT VALIDATION
Example Validation Status for Equipment
Validation Status
of Entitles
Validation Status Legend
Project Details
Example Decision Tree

4. 4
Documentation Consistency
ValGenesis utilizes templates in order to enforce documentation consistency. Templates used by organizations are uploaded into
ValGenesis and serve as the starting point for authoring any document. ValGenesis VLMS is flexible and allows any number of
templates to be uploaded into the system. Consistency is then enforced by associating the uploaded templates with specific
validation activities. For example, standard qualification templates can be uploaded and associated with installation qualification,
operational qualification, and performance qualification validation activities. Whenever a user is assigned the task of authoring a
document, only those templates that have been associated with the activity are available.
Along with templates, ValGenesis also provides users with the ability to further enforce consistency by utilizing a test function
capability. Test functions are standard tests cases, which can be reused across multiple documents. Test functions are uploaded into
thetestfunctionlibraryinValGenesis.
During the document authoring process, authors can select any of the test functions from the test function library. The selected
test functions can be automatically generated in the document template. By leveraging existing tests from a test function library,
consistency is ensured. Not only do test functions provide consistency; they also contribute to the acceleration of the document
authoring process.
Along with the functions described previously, ValGenesis is equipped with many additional capabilities that are designed to
improve the equipment validation lifecycle. Listed below are some of the additional functions of the system:
ValGenesis provides the ability for users to conduct functional and system level risk assessments. ValGenesis allows users to
configure risk models in the system to match an organization's risk management process. The system will automatically
calculate the risk class and risk priority numbers based on the assessed risk levels for each risk factor within the risk model.
The flexibility to define risk models ensures that organizations are able to maintain their current risk based process in an
automated fashion. Furthermore, for each assessed risk, a process condition can be assigned, which regulates the appropriate
course of action to be taken.
PAPERLESS EQUIPMENT VALIDATION
Example Test Function Library
Additional Capabilities of ValGenesis
Functional and System Level Risk Assessment
ValGenesis provides a powerful dynamic trace matrix functionality, which allows users to easily trace between individual
requirements and test cases associated with an equipment validation. This feature allows users to traverse bi-directionally
between requirements and test steps. If there is a failure during protocol execution, users can easily identify the test steps in
the protocol that failed and the impacted requirements. Similarly, when there is a GMP change to equipment requirements,
users can easily identify records from within protocols, which are associated with these requirements. This benefits
organizations by reducing the time to implement changes.
Automated Trace Matrix Generation and Updates
Functional and System Level Risk Assessment
Automated Trace Matrix Generation and Updates
Periodic Review and Revalidation Schedule Management
Electronic Execution with Objective Evidence

5. 5
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PAPERLESS EQUIPMENT VALIDATION
Example Calendar of Scheduled Periodic Reviews and Revalidations
Example Electronic Execution with Objective Evidence
The ValGenesis electronic protocol execution functionality allows users to execute and record test results electronically using
laptops, desktops, and tablets. ValGenesis automatically captures the full name and user ID of the engineer responsible for
executing each test and the date and time the test was recorded. Objective evidence can also be easily captured in the system in
the form of screenshots or file attachments. Each objective evidence is displayed as a hyperlink within the document.
Additionally, execution failures can be handled through an electronic deviation management workflow within the system.
Example System Level Risk Assessment and Process Conditions
The ValGenesis schedule management functionality allows users to build periodic review and revalidation schedules
according to approved procedures, which can help to provide alignment with the Validation Master Plan.
The system will automatically calculate the due date for the next activity based on the last completed validation or verification
date. These schedules can also be configured to send alert notifications prior to the due date of upcoming activities, ensuring
that all tasks are completed in a timely manner.
Electronic Execution with Objective Evidence
Periodic Review and Revalidation Schedule Management

6. Support
24/5 Support as
Standard
Solution
Standardized &
Harmonized Efficient
Validation Process
Services
Consultancy
& Training
Hosting
Safe, Secure &
Validated Cloud
Global
Implementation &
Multi-lingual Capabilities
About Valgenesis
About Valgenesis
Software
Multi-System
Integration
ABOUT VALGENESIS
CONTACT
www.valgenesis.com
info@valgenesis.com
1-888-825-4363
Compliance
Designed to adapt to and comply with regulatory requirements
Facilitate industry validation standards including GAMP 5.0 and ASTM E2500
Facilitate timely collection of data in preparing for internal and external audits
Benefits of Implementing ValGenesis VLMS
Cohesive Directional Information
Once implemented, all validation processes become more manageable
Adaptable paperless validation with existing IT infrastructure and business rules
Dashboards and reports locate bottlenecks in the validation process
Provides genealogy of corporate validation in real time
Consistency
Facilitates consistency through templates and reusing documents
Manages validation procedures through best practices
Simplifies through electronic access to validation data and documents
Cycle Time
Studies indicate that ValGenesis reduces validation cycle time by 50%
Configurable to meet existing business rules for faster Ready for Service and Quicker Return on Investment
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PAPERLESS EQUIPMENT VALIDATION