04/07/2022
What is CSV in pharma industry?
According to both American FDA and UK MHRA, computer system validation is defined as
“Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”
Purpose of CSV:
The purpose of the validation process is to provide a high degree of assurance that a specific process (or in this case computer system) will consistently produce a product
(control information or data) which meets predetermined specifications and quality attributes
Need of CSV:
FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of law.
Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.
CSV Processes:
Let’s look V-Model step-by-step breakdown
1 Master Planning
2 User Requirement Specifications
3 Functional Specification
4 Design Specifications
5 Configuring a system build
6 IQ tests
7 OQ test
8 PQ tests
9 Reporting.
Link:
https://lnkd.in/fgBUpki
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