Eliminates Data Integrity issues found in paper based process validation.

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ValGenesis, Inc.
Fremont, CA | Tampa, FL | Chennai, IND
info@valgenesis.com www.valgenesis.com

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info@valgenesis.com www.valgenesis.com
Agenda
Challenges with Paper Based Process Validation
Benefits of Managing the Process Validation Lifecycle in ValGenesis

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Background

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Background

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Challenges with Paper-Based Process Validation

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Challenges with Paper-Based Process Validation
Process design/development stage is not
integrated with validation stage
Misalignment with new process validation
guidance
Product lifecycle data found in disparate systems

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Challenges with Paper-Based Process Validation

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Benefits: ValGenesis Paperless Process Validation
Ability to have a central repository for all data and documentation
related to product design, development and validation
Lifecycle data resides in one location instead of binders and paper
documents that are not integrated in one single repository
ValGenesis is a web-based system that manages the entire validation
lifecycle process including electronic execution
Integration between the 3 stages of the process validation lifecycle
enables efficient issue resolution and investigations

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Benefits: ValGenesis Paperless Process Validation
Continuous Process Verification stage is integrated with Design and
Qualification stages
Paperless lifecycle management enables efficiency and cost
reduction
Data integration throughout the entire process validation lifecycle
Global visibility to data and process validation status of product
across the manufacturing network

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info@valgenesis.com www.valgenesis.com
Benefits: ValGenesis Paperless Process Validation
Integrated knowledge management across the
Lifecycle stages
Paperless lifecycle management enables
efficiency and cost reduction
Data integration throughout the entire process
validation lifecycle

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info@valgenesis.com www.valgenesis.com
Benefits: ValGenesis Paperless Process Validation
Global visibility to data and process
validation status of product across the
manufacturing network
Eliminates Data Integrity issues found in
paper based process validation.
Compliance with current data integrity
regulatory requirements

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info@valgenesis.com www.valgenesis.com
Benefits: ValGenesis Paperless Process Validation

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info@valgenesis.com www.valgenesis.com
Summary
Challenges with Paper Based Process Validation
Benefits of Managing the Process Validation Lifecycle in ValGenesis
During this session, we covered the following concepts:

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ValGenesis Inc
Ph: 510 445 0505
Email: info@valgenesis.com
www.valgenesis.com
Thank You