IT system validation skills matrix template

Overview Copied

With our free IT system validation skills matrix template, you will receive a clear overview of the skills that are present in your organization, as well as those that are missing. Using this information, you can develop and implement a plan to ensure that your employees’ skills are up to date, comprehensive, compliant, and ready for the future.

Regulatory compliance and standards

• Certified Information Systems Auditor (CISA)
• Certified Information Security Manager (CISM)
• Good Automated Manufacturing Practice (GAMP)
• FDA 21 CFR Part 11 Compliance
• ISO/IEC 27001 Certification
• Data Integrity in IT Systems
• Computer System Validation (CSV) Guidelines

Validation planning and documentation

• Validation Master Plan (VMP) Creation
• User Requirements Specification (URS)
• Functional Requirements Specification (FRS)
• Design Specification (DS)
• Traceability Matrix (TM)
• Certified Software Quality Engineer (CSQE)
• Certified Professional in Requirements Engineering (CPRE)
• Certified Quality Engineer (CQE)

Testing and execution

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• System Testing
• User Acceptance Testing (UAT)
• Certified Software Tester (CSTE)
• ISTQB Certified Tester (Foundation Level)
• Certified DevOps Professional (CDP)

Data management and security

• Data Migration Validation
• Data Backup and Recovery Procedures
• Cybersecurity Controls for Validated Systems
• Data Encryption and Integrity Checks
• Certified Information Security Manager (CISM)

Related skills Copied

Technical Proficiency: A solid understanding of IT systems, software development lifecycle, and the technological aspects of the systems being validated. This skill ensures the ability to comprehensively assess and validate complex software and hardware configurations.

Regulatory Compliance: Proficiency in interpreting and applying relevant regulatory guidelines, to ensure that validated IT systems meet compliance requirements.

Validation Strategy Development: Skill in designing an effective validation strategy, including defining validation deliverables, determining the scope of validation, and establishing risk-based approaches.

Test Scripting and Execution: Ability to create detailed test scripts, conduct validation testing, and document test results to ensure that the IT system functions as intended and meets user and regulatory requirements.

Documentation and Traceability: Strong documentation skills to create comprehensive validation documentation, including validation plans, protocols, reports, and traceability matrices. This ensures a clear and auditable record of the validation process.

Benefits Copied

Proficient IT validation, facilitated by skills management software, involves skilled professionals, ensuring rigorous testing, documentation, and regulatory compliance.

Download the free Excel IT system validation skills matrix template Copied

We also have a free Excel template available that you can download if you are not ready to get started with AG5. To download it, please complete this form here.

Author Copied

Wais

With a decade of experience, Wais leads our Customer Success team, providing exceptional customer experiences at AG5. Find him cooking a feast or hosting his podcasts in his spare time.

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