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Short Course

Course Information
Course Title: Computer Systems Validation (CSV) Script Writing Course / Workshop
Categories: 1 - Laboratory Information and Management
2 - Pharmaceutical Sciences
3 - Quality/Regulatory/Compliance
4 - Electronic Laboratory
5 - Technical Writing
6 - Validation
Instructor(s): Kurt Robak Course Number: 86
Affiliation: CSols, Inc.
Course Date: 03/09/2016 - Wednesday Course Length: 1/2 Day Course
Start Time: 08:30 AM End Time: 12:30 PM
Fee: $300 ($400 after 2/12/16) Textbook Fee:

Course Description
In this course, participants will get instruction on the overall Computer Systems Validation (CSV) process with an emphasis on writing test scripts. Discussions for each test type (e.g. IQ, OQ, PQ, Functional, Requirements, Integration, Acceptance, etc.) will be presented. Participants will also learn how to write negative tests, boundary tests and stress tests, and questions such as the following will be discussed: • How many steps do you put in a test case? • How do you plan and design a test case? • How much detail is needed? • What is appropriate to put in the Expected Results column? • Is it OK to put images in your test steps? • Should test cases be generic or written with a specific set of data in mind? The course then covers script execution, the final validation report and the traceability matrix. Finally, release of the system to production use will be discussed. After each topic, students will be given a chance to either practice the course content via hands-on workshops or review actual case studies of the subject matter presented.

Target Audience
• Informatics Project Participants • Quality Control and Quality Assurance Personnel • Laboratory Analysts • Technical Writers • Associates tasked with Validation Script Writing • Associates tasked with Validation Script Execution

Course Outline
• Overview of validation
• Predecessor documents to test scripts
o Validation Protocol/Plan
o User Requirements Specification (URS)
o Functional Requirements Specification (FRS)
o Configuration Specification (CS)
o Design Specification (DS)
• Validation terminology
• Types of tests:
o Positive
o Negative
o Boundary
o Stress
o Performance
o Regression
• How much detail?
• How to design a test case
• Writing an IQ script
• Writing an OQ script
• Writing a PQ script
• Executing scripts and dealing with script failures
• The Validation Report
• The Trace Matrix
• System release to production
o SOPs
o Change Control

Course Instructor's Biography
Kurt Robak is a Senior Consultant with CSols, Inc. and has been involved in various laboratory informatics implementation projects since 1992. He has 24 years of experience in CDS, ELN, LIMS and instrument systems and has been a PMP (Project Management Professional) since 2002.