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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.
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VALIDATION LIFECYCLE MANAGEMENT
ENFORCE CONSISTENCY IN THE VALIDATION PROCESS
REDUCE THE VALIDATION CYCLE TIME
STAY IN COMPLIANCE
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
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)
Top1 Reasons to Implement ValGenesis
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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Isn’t it time you went electronic?
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]
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
CONTROLValGenesis 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.
