Process Validation

CSA: Leveraging Supplier Assurance

Computer Systems Validation (CSV) offers numerous benefits when it comes to proving an assured state, but the documentation and resource requirements can be substantial. Wouldn’t it be easier if you could utilize testing that your vendors have already conducted?  Meet Chao, who is convinced that more paper equals more safety, and Cassandra, who champions the risk-based critical thinking efficiency of Computer Software Assurance (CSA). They both want a safe and effective validation, but each worries about what they’ll give up if they adopt each other’s practices.  Enter Lucy, who walks them through a strategy that meets both their needs: Leveraging Supplier Assurance (LSA).

Through Lucy’s tour of LSA,  guided practice, and real-world scenarios, you learn how to implement the central CSA principle -Trust, but Verify, Proportional to Risk -specifically for vendor-provided software. Find out how to strategically shift the assurance burden to the most knowledgeable party: the supplier.  With Lucy’s assistance,  you can make informed decisions that simplify validation, save substantial time and resources, and maintain the highest standards of patient safety, data integrity, and product quality.

CEU Credits: 0.1
Course Code: ELM-166B
Duration: 20 mins
Skill Level: Advanced
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.0
Effective Date: 12/18/2025

Curriculum for this course

Test Everything!
Chao CSV And Cassandra CSA
Lucy LSA
The Core of CSA/LSA
Supplier Assurance: The First Step in Risk Reduction
The Proportionality Principle in Action
Defining Non-Critical Software Risk Profiles and Associated Due Diligence
Defining Critical Software Risk Profiles and Associated Due Diligence
Doing Your Due Diligence!
Evaluating Supplier Development Maturity
Maturity Check
Regulations, Standards and Guidance
Establishing the Contractual Basis for LSA
Core Components of a Quality Agreement
Quality Agreement Responsibility Split
The Assured State: Beyond Initial Validation
Three Non-negotiable Supplier Life Cycle Controls
Monitoring and Auditing Supplier Controls
Control Conundrum
Informed Decisions
Test your Knowledge!
v2.0 Major Update 04/15/2026 This course has been redesigned and renamed from 'Computer System Validation – Supplier Provided Software' to 'CSA: Leveraging Supplier Assurance'. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well.
V1.1 Minor Update 12/01/2023 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.
V1.0 Course Released on 01/31/2021

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