Select Validation
plan, Add System
Information
Perform GxP
assessment
Setup document
workflow for review
and approval process
Review Validation
plan & Deliverables
Create
System/Project
Create Test case
with required steps
and protocols
(IQ/OQ/PQ)
Test execution
Update test steps
with actual result
Result
Status
Submit for approval
Discrepancy Form
Discrepancy
Workflow
Re execution (If
needed)
Fail
Pass
Approval /Esign
DMS with approved
documents
Validation summary
report
System release
certifictae
Set Project Plan
Upload
Specifications &
Configurations
Perform Risk
Assessment /Risk
Scoring
Upload required
forms and
documents based
on
recommendations
Periodic review & Schedules
Invite Users upload
requirements
Draft Requirements
Setup workflow and Route for
review and approval
Process flow of any validation project in GoVal Application
Validation Plan, GxP Assessment , Document workflow configuration
Specification, Configuration & Risk assessment
Review and
Approval process
Scripted Testing : Testing Phase with prerequisites and acceptance criteria
Choose a target
environment (Val/Prod)
Set the sequence ,
Assign the team for
Execution
Route for pre approval
Qualification Report
Update Site
inventory
Traceability Matrix
Add Documents
based on GxP
Recommendations
Reporting Phase & Conclusion
Compliance
Assessment
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Vendor
Assessment
& Impact
Assessment
Result
Status ?

Change Management
Process
Risk Rating for all
URS points
Review & Approval
Define Objective /
explore the
application and test
the low risk items
Define Test scripts
with expected
results and
prerequisites
Risk Score ?
Document testing
evidence , Result,
Deviation if any
Validation Summary
Report & System
Release certificate
High
Fail
Electronic Review & Approval
Test Result
Status
Pass
Traceability Matrix
Compliance &
Regulatory
Assessment
Defect Form &
Fixing the defects
Low
Unscripted Testing Scripted Testing
User requirement/ Intended
Use
Vendor Assessment
Initial assessment /
GxP Assessment
Adapt CSA Approach using GoVal
Driven by SOP to
define Risk Rating
Re Execution
If
Required
Review & Approval
GxP Inventory &
Periodic Review
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