Computer System Validation

ABOUT CISPACT TRAININGS

‘Cispact Trainings’ is an online education platform providing rigorous industry-relevant training programs designed and delivered in collaboration with world-class faculty and industry. Merging the latest technology, pedagogy, and services, Cispact is creating an immersive learning experience – anytime and anywhere.

We provide high-end professional education for aspiring and experienced professionals in Pharmaceutical and IT domains. Our hybrid platform delivers unique online experience that helps to build cutting-edge expertise, for today and tomorrow.

In Pharmaceutical sector, we provide trainings in Pharmacovigilance (Case Processing and Aggregate Report writing), Medical Writing, Management, Regulatory Affairs, Clinical Research Operations, Computer System Validation, Oracle Argus Configuration and Administrator, Clinical SAS (Base and Advanced) and Intellectual Property Rights.

Course Curriculum

  • Why validation is needed
  •  Definition of CSV
  •  Example Warning letters on CSV
  •  Challenges in CSV
  •  Benefits of Validation
  •  Which systems need to be validated
  • Validation Deliverables
  • GxP Assessment (IRA)
  •  Validation Plan
  •  URS
  •  FRS
  •  Configuration Documents
  •  IQ, OQ and PQ protocols and Reports
  • Traceability
  •  Validation Summary Report
  •  System Release Memo
  •  Roles and Responsibilities
  •  Types of Validation
  •  Introduction about GAMP 5
  •  Key Concepts
  •  V – Model
  •  Life cycle phases
  • Vendor Assessment
  • GAMP 5 Categories (Software and Hardware)
  • Risk Assessment methodology
  • Basic understanding of Risk Assessment
    • Risk Assessment Process
  • Performing Risk Assessment and calculating Risks
  • Risk Mitigation Approaches
  • Risk assessment benefits
  • Introduction and need of 21 CFR Part 11
  • Open systems
  • Closed Systems
  • Electronic Records and Signatures
  • Audit Trails
  • Controls for Open systems and Closed systems
  • Controls for Electronic Signatures and Identification codes and passwords
  • Benefits of 21 CFR Part 11
  • What is maintenance phase
  • Required SOPs during operation
  • Change Management
  • Configuration Management
  • Backup and Restoration
  • Periodic Review
  • System Retirement
    • System SOPs for Governance
    • System Retirement
  • General software implementation methods
    o On premise
    o Cloud bases (SaaS)
    o Cloud Computing models
    o SaaS
    o IaaS
    o PaaS
    • Implementation and Validation of Cloud based systems and compliance with regulatory requirements
  • Basic understanding
  • Importance of Data integrity in regulated environments
  • ALCOA + principles
  • Types of Vendor assessment methods
  • Performing vendor assessment
  • Preparing Vendor Assessment Reports

Writing Effective Qualification Documents

Good documentation practices

  • Mock Interview 1
  • Mock Interview 2
  • Mock Interview 3

FINAL ASSESSMENTS

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