Steps should be executed for performing CSV



In Earlier post we understand what is 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.

Data Integrity App








Steps which never missed in computer system validation.

 

GxP Assessment & System Categorization

 

System Level Risk Assessment

 

User Requirement Specifications (URS)

Electronic Records & Electronic Signatures Checklist (ERES)

 

Functional Specifications (FS)

 

Design Specification (DS)

 

Project Validation Plan (PVP)

 

Configuration Specification (CS)

 

Requirement Traceability Matrix (RTM)

 

Software Code Review

 

Qualification Protocol (IQ/OQ/PQP)

 

Generate Test Script

 

Qualification Report (IQ/OQ/PQR)

Data Migration Protocol 

Data Migration Report

 

Discrepancy Form (DS)

 

Discrepancy Log ( DL)

 

Validation Summary Report (VSR)

 

System Release Certificate (SRC)

 

Signature Log (SIL)

 

GAP Assessment

 

Screen Print Attachment

 

Validation Document Log (VDL)

 

Validation Master Plan

 

System Deliverable Matrix

 

Impact Assessment

 

CSV Document Preparation, Review & Approval Matrix

 

Project Change Management Form

 

Project Change Management Log

 

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

 “Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App

 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


Data Integrity App Link:


https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.


 

 

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