Validation Lifecycle

Management System
(VLMS)

VALGENESIS | VALIDATION LIFECYCLE MANAGEMENT SYSTEM (VLMS) 1

Robust, end-to-end solution that manages the Once a document is authored or executed, it must
Validation Lifecyle Process be physically sent to the corresponding reviewers/
approvers through interoffice mail or other delivery
Validation programs are still almost entirely manual methods. Paper documents can easily be misplaced or
or consist of a number of separate, uncoordinated lost causing time to be spent in searching/replacing
systems. Inefficiencies caused by human error cost documents
manufacturers millions of dollars annually, increase
product time to market, and introduce quality problems Compliance of Validation execution with ALCOA and
and data integrity issues. As the industry moves FDA Part 11/EMA Annex 11 – Further compounded in a
to PHARMA 4.0, companies are looking for a total manual process that compromises data integrity
validation management solution that ensures best
practices and data integrity governance, enforcing them Offline execution – Unable to execute test cases in
across all validation processes. clean rooms and manufacturing floors without network
connectivity
The ValGenesis VLMS is a 100% paperless Validation
Lifecycle Management System that has been adopted Creating end-to-end, Models and trace matrices – Time
as a system of record for validation since 2006. An consuming manual generation and maintenance of
end-to-end modularized system, the ValGenesis VLMS trace matrices, and a lack of traceability in complex
manages all types of validation processes, including software systems
CSV, Equipment, CQV, Method, Cleaning, and Process.
It is packed with unique features yet unmatched in the Risk based validation – Conducting risk assessment at
industry. Over 50 top global life sciences companies the system and requirement level is difficult to manage
testify to its efficacy after being audited and approved in a manual process
by global regulatory bodies as a system for validation
processes across the organization Requirements Level Impact Assessment – Productivity
is impacted as many resources are required to
maintain validation status where each change may take
ValGenesis VLMS: Efficient CSV weeks/months to close
Lifecycle Management
Accessing, recording and archiving data and sample
Enforcing approved VMPs and Validation Plans test results – Manual process to capture and archive
in the corporate validation program – Lack of data from instruments/equipment during validation
standardization and enforcement in the corporate and CPV, which leads to potential data integrity issues
validation process
Multilingual support – Lack of local language support
Inefficient manual process to generate validation
in GxP systems hampering the ability to convey work
deliverables – Lack of a single collaborative
instructions and operating procedures
environment in which an author can leverage existing
validation content and data across the organization.

VALGENESIS | VALIDATION LIFECYCLE MANAGEMENT SYSTEM (VLMS) 2

Unique Features and Advantages of ValGenesis validation. Data can be collected from instruments (pH
VLMS meter, weigh balance, etc.) and directly populated in
validation protocols, batch records, and log forms
Enforce approved Validation Plans, procedures and
best practices – A decision tree driven validation Robotic validation execution support – The VLMS
assessment process helps define the validation leverages the power of test automation tools for
requirements for GxP systems and processes as per the robotic validation execution and reduces validation
approved validation plan and procedures. Real-time execution time by up to 90%. Validated connectors for
validation status of these GxP systems and processes commonly available automation testing tools including
are available in the dashboard UFT, MS Coded UI, Leapwork, Tosca, etc. are provided

 fficient process to generate validation deliverables –

E Multilingual support – At site and user level. Any
ValGenesis VLMS provides functions to reuse content language can be supported. German, French, Japanese,
across the organization. It supports parallel, serial and Portuguese, Spanish, and Chinese are currently
hybrid workflows for review and approval to expedite supported by default
the final approval process
The ValGenesis VLMS is designed to electronically
Comply with ALCOA and Part 11/Annex 11 manage the entire validation lifecycle and remove
requirements – Upon clicking the record button during the inefficiencies that plague paper-based processes.
validation execution, data and content populate ValGenesis reduces the cost of the validation process
contemporaneously across rows with exact date and by allowing the optimization and stabilization of
time stamps, along with screenshots/attachments existing processes along with electronic management
(document authoring, test execution, review and
Offline execution support through Mobile Apps – Test approval) of validation process and procedures. This
case execution is supported via tablets/ mobile, with reduces the cost of the validation process as much
or without network connectivity, objective evidence are of the paper-based documentation and process/
dynamically captured in accord with the spirit of FDA 21 procedure approvals are eliminated.
CFR Part 11 and EMA Annex 11
ValGenesis VLMS is expected to reduce the cost and
 ynamically generate many types of trace matrices
D time of the validation lifecycle process by at least 50%
with minimal effort – Create references for if it is specifically configured to meet your validation
requirements and test cases with a simple click. process requirements, with adequate training of the
Dynamically generate any type of trace matrix: users.
comprehensive end-to-end, V model, one-to-many, and
many-to-one traces of all artifacts. The VLMS supports
forward and backward traces puter
System Validatio
n LIM
S Com S
DM Eq
n ui
pm
Efficient Risk based validation – Conducting risk at
io e
lid

nt

assessment at the system and requirement level

Va

Qu

Monitor Change
g

ali
gin

becomes easy to implement. The entire process is

Manager Control
fic
ka

ati
Pac

guided by the system. Any type of risk model can be

on

Periodic System
Review Assessment

adopted to conduct the risk assessment

VALIDATION
Qualification

Testcase LIFECYCLE Validation

Requirement Level impact assessment - Reduce Execution
MANAGEMENT Planner
Process V

SYSTEM
change management effort by up to 80% as a
ng &

validation summary of all impacted artifacts is Requirement

al i d

Traceability
oni

Management
Management
dynamically generated
a ti o

ss i
n

mi

Protocol Risk
m

Authoring Assessment
Co

 ccess and archive dynamic data through IoT and

A
Cl
OPC – IoT enabled access/capture of temperature, ea
nin da
ti o
n
gV al i
al i d dV
pressure, and humidity data in clean rooms, freezers, a tio
n M et
ho

etc. The VLMS further supports shipping and cold chain

VALGENESIS | VALIDATION LIFECYCLE MANAGEMENT SYSTEM (VLMS) 3

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