CSV - Intermediate

Computer System Validation – Supplier Provided Software

Software is either developed internally or procured from a software developer (ok, yes, there could be the case that you have an internal development team that “sells” development services to other divisions – they can be considered a vendor). Software suppliers can range from commercial software providers (e.g., Microsoft or Oracle) to “garage shop” software developers (hint: probably best to avoid garage shop providers regardless of cost!). In this course we will cover what you need to look out for when dealing with software vendors in a regulated environment.

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CEU Credits: 0.1

Course Code: ELM-166B

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.1

Effective Date: 08/16/2021

Curriculum for this course

Introduction

Overview

Learning Objectives

Who Should Take This Course?

Course Modules

Module 1: Background

Where is Software Used?

Validation Is More Than Testing

Scope Of This Course

Why Validate – Part 1

Why Validate – Part 2

Hope Through Validation

Regulations, Standards and Guidance

Module 10: Supplier Provided Software

Internal or External Suppliers

Supplier Selection & Management – What To Look Out For!

Supplier Controls – What to Expect From a Quality Agreement

Specify Your Requirements

Controls Throughout The Life Cycle

Development Methods or Models

Risk Management

Traceability

Design Reviews

Programming Standards

Code Reviews

Testing

Data Migration

Document Management

Change Control

Configuration Management

Issue Management

Leveraging Supplier Involvement

Quality Management System (QMS)

Establishing Requirements

Design Reviews

System Testing

Release Documentation

User Documentation and Training

Support and Maintenance

Conclusion

Final Assessment

Certification

Revision History

Minor Update: Conclusion slide previously reflected the learning outcomes of the course titled "Computer System Validation – Maintaining the Validated State". This has been corrected and updated to reflect the learning outcomes of this course, Supplier provided software.

V1.1