As a pioneer in the development of automated validation software solutions, ValGenesis, Inc. leads the way with a unique paperless validation process that tracks the validation status of any GxP system in real time. With years of development and refinement in place, ValGenesis is the first to offer users real-time paperless validation via electronic execution thereby minimizing ineffectiveness and maximizing efficiency. ValGenesis automates and manages the validation life cycle and provides real time validation status of any system corporate wide.

1. V
ALIDATIONLIFECYCLE MANAGEMENT
ENFORCE CONSISTENCY IN THEVALIDATIONPROCESS
REDUCE THE VALIDATIONCYCLETIM
E
STAYINCOMPLIANCE
PDA awarded ValGenesis the New Innovative Technology award for
Paperless Validation Lifecycle Management Technology
ValGenesis
offers the first, fully integrated, paperless
Validation Lifecycle Management Software
system that will greatly improve compliance, consistency and reduce
the validation costs.
Computer System Validation I Instrument and Equipment Validation I Process Validation I Cleaning Validation

2. ValGenesis is an Enterprise Validation Lifecycle
Management System (VLMS) that manages
the entire validation lifecycle from validation
planning, risk assessment, requirements
management, document authoring, electronic
execution, developing interactive traceability
matrices, change management and on to
periodic review.
A recent study on correlating validation related
issues cited in FDA’s 483s and warning letters,
issued from Jan 2007 - March 2009, with
the functionality of ValGenesis, reveals that
implementing a VLMS can avoid these cited
validation issues by at least 95%. In addition,
ValGenesis helps to enforce consistency
and enhance compliance in the validation
process across the company and removes
the inefficiencies that plague paper-based, or
hybrid, validation systems.
ValGenesis can be configured to enforce risk-
based validation approaches (ASTM E2500
and GAMP 5.0) and is fully compliant with 21
CFR Part 11 requirements. ValGenesis can be
implemented at the site level and is completely
scalable to a corporate-wide roll-out for all
types of validation requirements.
Validation systems are still almost entirely
manual or consist of a number of disparate,
uncoordinated systems. Inefficiencies caused
by human error cost manufacturers millions
of dollars annually, increase product time-to-
market, and introduce quality problems that can
result in regulatory actions including stringent
penalties. Validation deficiencies are still the
number one reason for the issuance of FDA
warning letters. Regulatory agencies are calling
for more “state-of-the-art” systems to replace
older manual systems.
Microsoft
.NET and
XML Technology
100% Web based
and Global Access
Rapid
Implementation
Web Services to
interface with
Deviation, ERP etc.
Supports SQL
Server and Oracle
ROI - Less than
a Year
Connector for
Documentum
Connector for
SharePoint Portal
Connector for QTP
(Test Automation
tool from HP)

3. Top
1 Reasonsto
ImplementValGenesis
Track The Validation Status In Real Time
Through Kpi Dashboards
Always Ready For Internal And
Regulatory Audits
Use Our Integrated Change Management
Process Or Interface With Your Corporate
Change Control System
Reduce The Cost Of
Validation Process By 30-40%
Enables A 100% Paperless
Validation Process
Enforce Consistency In The
Validation Process
Electronic Validation Process Meeting
FDA 21 Cfr Part 11 Compliance Requirements
Reduce The
Validation Cycle Time By 40-50%
Enables Lifecycle Approach In The Corporate
Validation Process With Integrated Modules
Harmonize And Globalize The
Validation Process
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4. Isn’t it time you went electronic?
Contact Information:
47102 Mission Falls Court | Ste 218, Fremont, CA 94539
Phone: 1-888-825-4363 & (510) 445-0505 | Fax: (510) 991-9901
www.valgenesis.com | Email: info@valgenesis.com
COST
SAVINGS
Save 30% or more on your current validation costs and
reduce your cycle time by 40%. These savings generally
provide payback in less than a year and means greatly
improved time-to-market for your products.
CONFIGURATION
CONTROL ValGenesis tracks validation status in real time,
securely stores, retrieves documents and reports
any project delay instantaneously.
ValGenesis is fully configurable giving
the flexibility to meet your corporate
needs. The ready-for-service time is
reduced and return-on-investment
starts immediately. Our open
architecture can be configured to work
with existing systems.
COMPLIANCE
In keeping with the FDA’s push for more advanced systems,
ValGenesis will greatly reduce the errors caused by manual,
paper based methods, guarantee data integrity, provide full
audit trails and ensure accountability. And, of course, the
system is fully compliant with FDA’s 21 CFR Part 11.
CONSISTENCY
From site to site, or even department to
department, ValGenesis will create standard
templates and workflows that provide a disciplined
approach to validation.