Description
Validating Commercial Off-The-Shelf (COTS) software, Software-as-a-Service (SaaS), and cloud systems involves ensuring that these solutions meet the specific functional, security, and regulatory requirements of the organization using them. This process includes thorough risk assessments, security evaluations, and compliance checks to verify that the software operates as intended within the organization’s environment and complies with industry standards such as ISO/IEC 27001 for information security management and GDPR for data protection. It also involves continuous monitoring and regular audits to ensure ongoing compliance and performance, as these solutions are often updated by vendors. Validation efforts aim to mitigate risks associated with third-party software and ensure that the deployment aligns with the organization’s strategic goals and regulatory obligations?
This online course will teach you how to validate and maintain compliance for commercial-off-the-shelf, software-as-a-service, and cloud systems. This online course dives into this discipline required for FDA compliance. The course is organized into 7 (seven) modules:
Module 1. Computer System Validation
Module 2. Qualification Testing
Module 3. Preparation for Go-Live
Module 4. Validation Approaches
Module 5. Data Integrity
Module 6. Cloud, commercial off the shelf, and Software as a service systems
Module 7. Cybersecurity
