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Challenges with Traditional Cleaning Validation
Silo approach where design and development are not integrated with
validation
Paper based which lead to significant inefficiencies and cost
Islands of information in paper, databases and file folders
Lack of visibility to data and cleaning validation status of equipment
Paper based execution creates delays and errors
3. 3
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ValGenesis Cleaning Validation Lifecycle
Design and development
is integrated with
validation
Paperless lifecycle
management enables
efficiency and cost
reduction
Data integrations
throughout the entire
cleaning validation
lifecycle
Global visibility to data
and cleaning validation
status of equipment
across multiple sites
Paperless execution
eliminates challenges
created with paper based
validation
6. 6
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Stage 1 & 2 Design, Development & Validation
Stage 1 typically includes the following example activities and deliverables
Cleaning study protocols – coupon, swab, recovery,
Cleaning study reports
Stage 2 typically include the following example activities and deliverables
Cleaning Validation Plan
Cleaning Validation Protocols – Visual inspection, TOC, Conductivity, Endotoxin,
Product Residue testing
Validation Summary Reports
7. 7
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Stage 1 & 2 in ValGenesis
ValGenesis framework function provide the ability to manage the requirements for
stage 1 & 2
The framework can be used to define the requirements to consider cleaning validation
complete
Cleaning Validation projects can be created to enforce quality checks against process
deliverables
Stage 1 & 2 ValGenesis framework can have the following deliverable requirements
Cleaning Study Summary Report (complete & approved)
Cleaning Validation Protocols (complete & approved)
Validation Summary Reports (complete & approved)
8. 8
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Stage 3 Continued Process Verification (CPV)
ValGenesis provide electronic equipment logs
that can be used to monitor and manage the
performance of validated cleaning cycles
Cleaning process parameter failures can be
managed in ValGenesis using electronic
deviations
Periodic review and revalidation protocols can be
created, reviewed, approved and executed in
ValGenesis
Revalidation summary reports can be created,
reviewed and approved in ValGenesis
9. 9
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Benefits: ValGenesis Paperless Cleaning Validation
Ability to have a central repository for all data and documentation
related to cleaning cycle design, development and validation
Cleaning 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
10. 10
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Benefits: ValGenesis Paperless Cleaning Validation
Continuous Cleaning Process Verification stage is
integrated with Design and Qualification stages
Paperless Cleaning Validation lifecycle management
enables efficiency and cost reduction
Cleaning Validation data integration throughout the
entire process validation lifecycle
Global visibility to data and cleaning validation
status across the manufacturing network
11. 11
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Benefits: ValGenesis Paperless Cleaning Validation
Integrated knowledge
management across the
Cleaning Validation Lifecycle
stages
Paperless Cleaning Validation
Lifecycle Management enables
efficiency and cost reduction
12. 12
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Benefits: ValGenesis Paperless Cleaning Validation
•ValGenesis enables the following functionality:
Decision trees can be defined based on the process validation standard
operating procedures and policies
Decision trees auto generates the Process Validation protocols based on
responses from the users
Supports creation of Process Validation plan to enforce the deliverable
requirements and periodic review schedules
Workflow based system manages the entire Process Validation lifecycle
along with required supporting data and documents
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Benefits: ValGenesis Paperless Cleaning Validation
•ValGenesis enables the following functionality:
Supports a risk based approach at the individual critical parameter and
attribute level
Decision trees, protocols, templates and processes can be shared and
reused across multiple sites globally
Provides real-time process validation status through a KPI
Electronic execution
