Steps should be executed for performing Computer System Validation

In Earlier post we understand what is Computer System Validation (CSV), Why CSV Required, Purpose of CSV & Benefits of CSV.

Now in this article we are going to understand steps which should be executed during computer system Validation activity. These steps will helpful to understand how CSV will be performed.

Each & every steps having its own importance. So, Never miss any steps while performing validation activity.

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Steps which never missed in computer system validation.

1	GxP Assessment & System Categorization
2	System Level Risk Assessment
3	User Requirement Specifications (URS)
4	Functional Specifications (FS)
5	Design Specification (DS)
6	Project Validation Plan (PVP)
7	Configuration Specification (CS)
8	Requirement Traceability Matrix (RTM)
9	Software Code Review
10	Qualification Protocol (IQ/OQ/PQ/IFQP)
11	Generate Test Script
12	Qualification Report (IQ/OQ/PQ/IFQP)
13	Discrepancy Form (DS)
14	Discrepancy Log ( DL)
15	Validation Summary Report (VSR)
16	System Release Certificate (SRC)
17	Signature Log (SIL)
18	GAP Assessment
19	Screen Print Attachment
20	Validation Document Log (VDL)
21	Validation Master Plan
22	System Deliverable Matrix
23	Impact Assessment
24	CSV Document Preparation, Review & Approval Matrix
25	Project Change Management Form
26	Project Change Management Log

All these above steps are need to be performed during successful computer system validation. Let’s break down each part a little bit further in next article.

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