Clinical Research & Trials Pharma & Biotech

CSV: GxP Compliance, Cloud, AI and Continuous Validation

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End-to-end Computerized System Validation—from GAMP 5 and risk-based validation to cloud, AI, go-live and continuous compliance.

By HUKSA

Last updated September 17, 2026

This three-day program equips pharmaceutical, biotechnology and life-sciences professionals with the knowledge, frameworks and practical tools required to execute, document and manage Computerized System Validation in GxP-regulated environments. It covers the complete CSV lifecycle—from system categorisation, URS and risk assessment through IQ, OQ, PQ, go-live and periodic review—while addressing 21 CFR Part 11, EU Annex 11, GAMP 5, cloud, SaaS, AI/ML and Agile validation. Practitioner cases, template walkthroughs and validation exercises connect regulatory expectations with real project execution.

Who Should Attend

Validation Engineers and CSV Consultants
QA, Compliance and Regulatory Affairs professionals
IT Project Managers, System Owners and Business Analysts
Clinical, Pharmacovigilance, LIMS, CTMS and Veeva System Owners
IT Infrastructure, Cloud and Digital Transformation teams

Business Outcomes

Develop inspection-ready CSV strategies aligned with GAMP 5 and GxP requirements.
Apply risk-based validation without creating compliance gaps or over-validation.
Produce traceable lifecycle documentation from URS through PQ and system release.
Validate SaaS, cloud and AI-enabled systems using appropriate modern approaches.
Sustain the validated state through change control, periodic review and continuous monitoring.

Course Content

Foundations of CSV and the Regulatory Landscape

Lesson Content

0% Complete 0/5 Steps

What Computerized System Validation is and why it matters in GxP environments

Regulatory landscape: FDA 21 CFR Part 11, EU Annex 11, ICH Q10 and PIC/S

Key definitions: validated state, qualified system and lifecycle approach

Consequences of non-compliance, including warning letters, Form 483 observations and recalls

Regulatory Case Discussion: Identify CSV and data-integrity gaps in a regulated-system scenario

Lesson Content

0% Complete 0/5 Steps

GAMP 5 and the risk-based approach to CSV

Software Categories 1–5: infrastructure, non-configured, configured and bespoke systems

Selecting the appropriate validation strategy for each system category

GAMP 4 versus GAMP 5: evolution and practical differences

System-Categorisation Exercise: Classify representative GxP systems and define their validation approach

Lesson Content

0% Complete 0/5 Steps

Understanding the CSV V-Model from URS through PQ

Mapping User, Functional and Design Specifications

IQ, OQ and PQ: definitions, acceptance criteria and execution

Traceability matrices linking requirements with test evidence

Traceability Lab: Connect sample URS requirements with specifications and qualification evidence

Lesson Content

0% Complete 0/5 Steps

Synchronising IT project delivery with GxP validation requirements

Roles of the business owner, system owner, QA and IT

Governance structures for enterprise validation programmes

Integrating change control with the CSV lifecycle

Governance Simulation: Resolve accountability gaps within a cross-functional validation programme

Documentation, Risk and Compliance Practice

Lesson Content

0% Complete 0/5 Steps

Structuring a CSV Plan: scope, approach, resources and timeline

Master Validation Plan for enterprise-level validation governance

Document control and version management in GxP environments

Walkthrough of real-world CSVP examples

Documentation Lab: Develop the structure of a Computer System Validation Plan

Lesson Content

0% Complete 0/5 Steps

Risk identification across process, GxP impact and data integrity

Conducting a System Impact Assessment and GAMP risk assessment

Calibrating test depth to risk level and avoiding over-validation

Risk-register format, ownership and lifecycle management

Risk Assessment Workshop: Build a system risk register and determine validation depth

Lesson Content

0% Complete 0/5 Steps

Challenges of validating cloud-hosted and SaaS systems such as Veeva and Azure-hosted platforms

Vendor audits and evaluation of SOC 2 and ISAE 3402 reports

Shared responsibility model: vendor versus sponsor obligations

Cloud IQ without physical access to infrastructure

Cloud IQ Case: Define an infrastructure-qualification strategy for a SaaS-based GxP system

Lesson Content

0% Complete 0/5 Steps

Designing OQ scripts with positive, negative and boundary scenarios

PQ using real business data, user acceptance and sign-off protocols

Managing deviations and qualification failures through impact assessment

PQ summary reports and release for intended use

Qualification Lab: Develop OQ/PQ scenarios, expected results and deviation responses

Advanced CSV, Cloud, AI and Go-Live

Lesson Content

0% Complete 0/5 Steps

Regulatory expectations for AI/ML tools used in GxP decision-making

AI-driven CSV risk assessment to optimise validation scope

Data-integrity considerations for AI outputs in regulated workflows

AI-assisted validation in a global pharmaceutical environment

AI Validation Case: Assess intended use, risk, data integrity and human oversight for a GxP AI tool

Lesson Content

0% Complete 0/5 Steps

Moving from project validation to continuous compliance monitoring

Periodic review, revalidation triggers and change-driven requalification

Integrating CSV with IT Service Management tools such as ServiceNow and Jira

Metrics and KPIs for compliance-programme health

Continuous-Validation Lab: Design a monitoring and periodic-review framework

Lesson Content

0% Complete 0/5 Steps

Applying Agile and Hybrid methodologies in a GxP-regulated environment

Sprint planning for validation deliverables while maintaining compliance pace

Mapping user stories to URS and FRS

Regulatory acceptance of Agile under GAMP 5 Second Edition guidance

Agile CSV Exercise: Build validation deliverables into a representative sprint plan

Lesson Content

0% Complete 0/5 Steps

Validating Azure, AWS and Google Cloud platforms in a GxP context

Hybrid-cloud validation and data-residency compliance

Emerging AI validation frameworks from FDA and EMA guidance

Practical lessons from a global GxP archival platform on Azure

Architecture Review: Evaluate a cloud-validation model across infrastructure, platform and application layers

Lesson Content

0% Complete 0/5 Steps

Go-live readiness: completed validation and closure of open deviations

Cutover planning, data-migration validation and data-integrity checks

Post-go-live monitoring and hypercare validation support

Validation Summary Report and system-release memo

Go-Live Readiness Review: Conduct a validation gate review for a regulated-system launch

Lesson Content

0% Complete 0/6 Steps

Building a sustainable CSV programme beyond initial project validation

Change-control SOPs for minor and major changes

Revalidation thresholds and change-driven qualification

Annual product review integration with the CSV lifecycle

Regulatory-inspection readiness, mock audits and response management

Final Capstone: Develop an end-to-end CSV strategy for a selected GxP computerized system

Meet Your Instructor

Deep-domain, High Precision L&D - delivered directly by Renowned Industry Practitioners HUKSA

299 Course

290 Student

Offered by Huksa, this L&D program is led by elite industry veterans—CXOs and Functional Heads with 25+ years of deep-domain expertise. You have the flexibility to customize the curriculum, select your preferred expert, and align the program to your organization’s specific objectives. Connect with the Huksa team to explore our array of top-tier trainers available for this course!

₹240,000

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This course includes:

Lessons 14
Topics 71
Duration 3 Days
Quizzes 0
Language English

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CSV: GxP Compliance, Cloud, AI and Continuous Validation

Who Should Attend

Business Outcomes

Course Content

Meet Your Instructor

Deep-domain, High Precision L&D - delivered directly by Renowned Industry Practitioners HUKSA

This course includes:

Validation Principles and Practices for Pharmaceutical Quality

Vaccine Procurement and Tender Management under UIP for Procurement in Pharmaceutical

US FDA Audit Preparedness for Quality & Compliance in Pharma

Sustainable Waste Management in Pharma

Strategic Publication Planning for Pharmaceutical Organizations

Strategic Pharma Costing & Pricing Excellence

Strategic Execution for Pharmaceutical Sales and Marketing

Statistical Process Control (SPC) for Pharmaceutical Manufacturing

Stability Operations for Pharmaceutical Quality

CSV: GxP Compliance, Cloud, AI and Continuous Validation

Who Should Attend

Business Outcomes

Course Content

Meet Your Instructor

Deep-domain, High Precision L&D - delivered directly by Renowned Industry Practitioners HUKSA

This course includes:

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