Risk Based Validation

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The inventive age computer arrangement for
verification determinations

• http//valgenesis.com

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Products
CSV SAP Validation Method Validation Risk Based
Validation Equipment Log Management FDA Process
Validation Computer System Validation
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Introduction

• Enterprise Validation Lifecycle Management
  System ValGenesis 
• As a pioneer in the development of
  automated validation software solutions,
  ValGenesis, Inc. leads the way with a
  unique paperless validation processthat 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.
• ValGenesis is fully configurable giving you the
  most flexibility in terms of tailoring the
  application to meet your corporate needs
  specifically.The system administrator at your
  site is capable of carrying out required changes
  to mirror your current process flow without any
  special programming skills required. The
  advantages of its configurable design mean that
  your RFS (Ready for Service) time is reduced and
  the ROI (Return on Investment) can commence
  immediately.

Technology Overview - ValGenesis VLMS is a
web-based, modularized, configurable and
closed-loop enterprise validation lifecycle
management solution. ValGenesis VLMS is a
multi-site application whereby a single instance
of the system can be used for any validation
process across multiple sites within your
organization. Each site that is created in
ValGenesis VLMS can be configured differently
with different sets of data. Users can be given
different levels of access to the functions and
data within each site.
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CSV
There FDA Paperless Validation are the bas entity
or objects by place of meant on facts you all can
take the act or stroke powerfully
building Electronic Log Management based on part
completed as well as by basic new benefits. There
are any more which can help in completing Validati
on process management what is left and that part
is exactly in action of the work. There are
categories of how things will CSV happen in other
work nature.
System Overview - ValGenesis is a 21 CFR Part 11
compliant web-based closed-loop Validation
Lifecycle Management System that manages the
entire validation lifecycle process. Starting
from the Validation Plan, Risk Assessment,
Project Planning, Requirements Management,
Dynamic Trace Matrix generation and then moving
on to Test Case/Protocol Development, Electronic
Execution and completing the validation life
cycle with the Decommission/Retirement process.
In addition to the Validation Lifecycle
Management process, the ValGenesis system
supports Application Lifecycle Management, Change
Management, Periodic Review and GxP Log
Management within the system as closed-loop
processes.
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