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CSV Flow Chart

CSV Flow chart

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Prasad Pasupuleti
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40 views

CSV Flow Chart

CSV Flow chart

Uploaded by

Prasad Pasupuleti
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Computer System Validation Process:

The CSV process involves a series of well-defined steps:

1. Planning and Strategy: Defining the scope, objectives, and


resources required for CSV.

2. User Requirement Specification (URS): Documenting user


needs and system functionalities to guide system development.

3. Functional Specification (FS): Describing how the system will


meet user requirements.

5. System Build: This step includes unit testing and


integration testing.
The IQ tests are performed to evaluate the DS
The OQ tests are performed to evaluate the FS
The PQ tests are performed to evaluate the URS
4. Design Specification (DS): Translating functional
specifications into technical design.

6. Installation Qualification (IQ): Verifying that the system is


properly installed.

7. Operational Qualification (OQ): Demonstrating that the


system functions according to specifications.

8. Performance Qualification (PQ): Ensuring that the system


consistently performs within defined parameters.

9. Requirement Traceability Matrix: To ensure that all


requirements defined for a system are tested in the test protocols

10. Validation Summary or System Certification: Provides


confirmation that all activities specified in the validation plan
have been completed

11. System Release: System release note confirm that system is


validated and ready for its intended use.

Arvind Kumar Srivastava, Manager – Qualification & Validation, Mobile No. : 9817039581, Email ID: arvindsri82@gmail.com

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