Streamline Your Validation Process with GoVal - Features and Benefits
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Discover how GoVal can help you streamline your validation process with its powerful features and benefits. Our presentation will cover topics such as URS, risk assessment, test case management, and more. With GoVal, you can achieve faster validation, better collaboration, and improved compliance. Check out our presentation now and learn more about the benefits of using GoVal for your validation needs
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The document outlines the 6 phases of a project implementation process:
1. Project planning phase involves defining objectives, timelines, risks and organizing project teams.
2. Project design phase involves reviewing requirements, creating system designs and test plans.
3. Build and unit test phase involves developing applications, installing systems and executing unit tests.
4. Integrated test phase involves creating test plans, executing tests and providing test status reports.
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1. Project planning phase involves defining objectives, timelines, risks and organizing project teams.
2. Project design phase involves reviewing requirements, creating system designs and test plans.
3. Build and unit test phase involves developing applications, installing systems and executing unit tests.
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The NASA Program/Project Life Cycle Process Flow diagram shows the key phases and gates of a typical NASA program from initial concept through operations and disposal.
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Validation provides evidence that a model or process is strong, powerful, and designed for its intended task. The objectives of validation include ensuring product quality, manufacturing consistency, process reproducibility, and demonstrating process robustness. Successful validations require comprehensive training programs, validation protocols, batch sheets, critical cGMP programs, and validation master plans approved by all departments including regulatory affairs. Major challenges in validation include ensuring sterility, critical cGMP programs, instrument calibration, preventive maintenance, cleaning procedures, supplier audits, and environmental and process monitoring programs. Types of validation include prospective, concurrent, and retrospective validation. Steps involve facility acceptance testing, IQ/OQ/PQ qualification, identifying critical parameters, validating the process, and documenting validation records including critical
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validationmasterplan-180918073044 (3).pdf
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Definition of done
This document defines a "Definition of Done" checklist that must be met for a software feature to be accepted and released. The checklist includes items related to code quality, testing, documentation, collaboration, and updating relevant system records. Meeting the Definition of Done ensures expectations are shared between the engineering team and product team regarding what constitutes a completed feature.
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Streamline Your Validation Process with GoVal - Features and Benefits
- 1. 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 www.govalidation.com Vendor Assessment & Impact Assessment Result Status ?
- 2. 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 www.govalidation.com