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.

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: 16/08/2021

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
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
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

Conclusion

Final Assessment

Certification

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

Author

Kevin Martin

Managing Partner at Azzur

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