CSV Course

Service Description

Computerized System Validation Certification Computer validation is more than a compliance requirement. It not only reduces regulatory risk, but it also increases understanding of system during project implementation and enforces a structured, well-defined execution of the project. This course will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale. Additionally, this course will be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, Quality Control and other job functions which are impacted by CSV efforts. This is Online Training and Certification course for Computer System Validation (CSV) Study Modules 1: Software Validation & Infrastructure Qualification 2: Computer System Validation (CSV) - Overview, Regulatory requirements (GAMP & 21 CFR Part 11) and documentation 3: High Level Risk Assessment (GxP Assessment, ERES Assessment, Criticality Assessement, SoX, Confidentiality Assessment) 4: Categories of Software Based on GAMP-5 Guideline. 5: Supplier Assessment as per regulatory guidelines. 6: Electronic Record and Electronic Signature (ERES) Assessment as per 21 CFR part 11 and EU Annexure 11 Guideline. 7: GAMP 5 and documentation (URS, FS, DS, CS, Source Code Review Report, Validation Plan, Validation Report, Test Plan & Test Summary Report) 8: Quality Risk Management (Quantitative and Qualitative Risk Assessment, Functional Ris Assessment). 9: Testing of Computerized System (IQ, OQ, PQ, UAT, Regression Testing, Smoke Testing, Sanity Testing) 10: Penetration Testing (Threat Modeling, SAST & DAST) Module 7: Excel Sheet Validation 11: Cloud Computing (SaaS, PaaS, IaaS) 12: Software Development Life Cycle (SDLC) : Waterfall, V-Model, Agile Methodology, DevOps etc. Module 13: Back-up and Restore, Archival & Retrieval of Data 14: Business Continuity Management (Disaster Recovery Management & Business Continuity Plan) 15: System Retirement & Data Migration 16: Open System Controls and Closed System Controls. 17: Computer Software Assurance (CSA Approach), A New way of CSV Eligibility Graduation of any stream. For More Details on Computerized System Validation, visit Training and Certification Page

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