Computer System Validation - Training

Contact:  Enoptions Inc :  732 662 3479   or


Class starts on May 18the.


We Enoptions Inc has considerable experience in developing /deploying Pharmacutical applications to our clients. Both off the shelf and custom solutions. We have been doing consulting for many Pharmacutical and medical device companies on Computer System Validation.  We are offering Training class on Computer System Validation . If you are working in a regulated environment , this course is for you or are you looking to get into Health care industry then this is a the course you should be taking to get that special skills that put you ahead of the herd.  We provide you access to our Pharmacutical product to get you the real life experience on doing the validation.


We cover following topics:



Over view of Pharmaceutical industry and why Validation ?


21 CFR Part 11

Validation Methodologies

SLC- System Life Cycle


Introduction to Innova ADMT (Pharma application)



CSVP- Computer System Validation Plan

MP- Master Plan

CSVTP- Computer System



URS- User Requirement Specification

FRS- Functional Requirement Specification

UFRS- Combination on above.

SDS- System Design Specification.


SOP-  Standard Operating Processors.

WI- Work Instructions

Change Control Management System

GAP Analysis

RTM- Requirement Traceability Matrix


IQ- Installation Qualification

OQ- Operational Qualification

PQ- Performance Qualification



TP- Test plans

TS- Test Strategies

TC- Test Case

TSR- Test Summary Report

TR- Test Reports

TS- Test Summary

VSR- Validation Summary Report

CSVSR- Computer System Validation
Summary Report



Cots- Commercial of the selves




Water Model

Spiral Model




GMP- Good Manufacturing Practice

GCP- Good Clinical Practice

GLP- Good Laboratory Practice


Incidents/ Deviation / Discrepancies

Risk Analysis/ Assessment

Vendor Assessment

Internal /External Audits

Vendor Audits



Name Sales End Price Fee
Computer System Validation Course- Pharma Ended $600 $9.95

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