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.

Curriculum for this course:
Overview 1 min 10 secs
Learning Objectives 1 min 31 secs
Who Should Take This Course? 1 min 18 secs
Course Modules 1 min 15 secs
Module 1: Background
Where is Software Used? 1 min 42 secs
Validation Is More Than Testing 2 min 10 secs
Scope Of This Course 1 min 38 secs
Why Validate – Part 1 1 min 42 secs
Why Validate – Part 2 1 min 50 secs
Hope Through Validation 1 min 33 secs
Regulations, Standards and Guidance 1 min 58 secs
Module 10: Supplier Provided Software
Internal or External Suppliers 1 min 12 secs
Supplier Selection & Management – What To Look Out For! 1 mins 29 secs
Supplier Controls – What to Expect From a Quality Agreement 1 min 21 secs
Specify Your Requirements 1 min 25 secs
Controls Throughout The Life Cycle 1 min 10 secs
Development Methods or Models 1 min 09 secs
Risk Management 1 min 30 secs
Traceability 1 min 11 secs
Design Reviews 1 min 14 secs
Programming Standards 1 min 01 secs
Code Reviews 58 secs
Testing 1 min 15 secs
Data Migration 1 min 09 secs
Document Management 1 min 18 secs
Change Control 1 min 18 secs
Configuration Management 58 secs
Issue Management 38 secs
Leveraging Supplier Involvement 48 secs
Quality Management System (QMS) 58 secs
Establishing Requirements 47 secs
Design Reviews 1 min 18 secs
System Testing 39 secs
Release Documentation 1 min 30 secs
User Documentation and Training 1 min 02 secs
Support and Maintenance 1 min 01 secs
Final Assessment

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