Computer System Validation – Supplier Provided Software
Description:
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:
Introduction
| 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 |
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 |
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-166B -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: V1.1 -
Effective Date: 16/08/2021
Reviews:
Assessing software vendors before purchasing is a critical aspect of working in a GMP environment. This course goes through all of the various aspects in way that is easy to understand and implement.
Loved the section on supplier controls, this course is a great refresher for anyone working in software procurement.
Related courses:
Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5
Computer System Validation – The Regulated Software Life Cycle
Computer System Validation – Requirements: The Basis for Validation
Computer System Validation – Risk Management
Computer System Validation – The Master Validation Plan (MVP)
Computer System Validation – Application of the Validation Plan
Computer System Validation (CSV) – Validation Testing Part 1
Computer System Validation (CSV): Validation Testing – Part 2
21 CFR Part 11 – An Introduction
21 CFR Part 11 – Electronic Records
21 CFR Part 11 – Electronic Signatures
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