Definition
Computer system validation (CSV) is the process of ensuring that a computer system meets its intended use and performs as expected, while computer system/software assurance (CSA) is the process of ensuring that a computer system is secure, reliable, and available.
Purpose
The purpose of CSV is to ensure that a computer system meets regulatory requirements and industry standards, while the purpose of CSA is to ensure that a computer system is protected from security threats and operates reliably.
Scope
CSV focuses on the validation of software applications and hardware components, while CSA focuses on the overall security and reliability of the entire computer system.
Methodology
CSV uses a structured approach to testing and documentation to ensure that a computer system meets its intended use, while CSA uses risk assessment and mitigation strategies to protect against security threats.
Compliance
CSV ensures compliance with regulatory requirements such as FDA regulations for medical devices, while CSA ensures compliance with regulatory requirements + risk baised.
Testing
CSV involves testing software applications and hardware components to ensure they meet their intended use, while CSA involves testing the overall security and reliability of the entire computer system.
Documentation
CSV requires detailed documentation of all testing activities and results, while CSA requires documentation of risk assessments and mitigation strategies.
Timeframe
CSV typically occurs during the development phase of a computer system or software application, while CSA occurs throughout the entire lifecycle of a computer system.
Responsibility
CSV is typically performed by quality assurance or validation teams within an organization, while CSA may be performed by IT security teams or external consultants.
Outcome (CSV vs CSA)
CSV
- Focus on regulatory
- Less testing-More Documentation
- More chances of script level and manual errors
- More chances of bugs and configuration errors in maintenance phase
- Supplier and resources utilization on documents
- Longer validation cycle
CSA
- Focus on regulatory + Risk based
- More Testing- Less Documentation
- Less chances of script level and manual errors
- More chances of smooth functioning during maintenance phase
- Excellent utilization of supplier and resources on quality improvement
- Reduced validation cycle time
FDA CSA Approach
- Identify Intended Use
- Determine Risk-Based Approach
- Determine Appropriate Assurance Activities
- Establish Appropriate Record
Read also: Frequently Asked Questions on Data Integrity