Short Course Listings
 
Short Course

Course Information
Course Title: (CANCELED) Computer Systems Validation (CSV) Script Writing Course/Workshop
Categories: 1 - Data Management
2 - Electronic Laboratory
3 - Laboratory Information and Management
4 - Quality/Regulatory/Compliance
5 - Technical Writing
6 - Validation
Instructor(s): Kurt Robak Course Number: 54
Affiliation: Csols, Inc
Course Date: 03/06/2017 - Monday Course Length: 1/2 Day Course
Start Time: 01:00 PM End Time: 05:00 PM
Fee: $325 ($425 after 2/18/17) Textbook Fee:

Course Description
Note: This is not a scripting language course. 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
Validation Plan / Protocol
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
Target Audience (360 Character Max.):
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 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 25 years of experience in CDS, ELN, LIMS and instrument systems and has been a PMP (Project Management Professional) since 2002.