Post graduate Diploma/Executive Diploma in Computer System Validation (PGDCSV/EDCSV)

Computer System Validation (CSV) is no longer viewed merely as a regulatory compliance requirement in the pharmaceutical and life sciences industry. In today’s digital and highly regulated environment, CSV plays a critical role in ensuring data integrity, patient safety, product quality, and operational excellence across computerized systems.

An effective validation approach not only minimizes regulatory and compliance risks but also enhances system understanding during implementation and throughout the system lifecycle. Modern CSV practices, aligned with current FDA guidance, GAMP 5 (2nd Edition), Data Integrity principles, and Computer Software Assurance (CSA) concepts, promote a risk-based, efficient, and scientifically driven validation strategy.

Computer System Validation provides organizations with a valuable opportunity to evaluate and optimize computerized systems for improved efficiency, reliability, compliance, and business performance. A well-executed CSV programme can significantly reduce operational errors, improve audit readiness, strengthen electronic records management, and save both time and cost through structured project execution.

Subject Matter Experts (SMEs) in CSV play a vital role in implementing compliant and sustainable digital systems by bridging quality, regulatory, technical, and business requirements. Their expertise is essential in validating systems such as LIMS, QMS, ERP, MES, eQMS, SCADA, cloud-based applications, AI-enabled systems, and other GxP-regulated platforms used across the pharmaceutical industry.

This programme is designed to benefit professionals involved in FDA, MHRA, EU GMP, WHO, and global regulatory inspections and Computer System Validation activities on both domestic and international levels. It is highly relevant for professionals working in Quality Assurance, Quality Control, Regulatory Affairs, Validation, IT, Informatics, Manufacturing, Engineering, Clinical Research, Pharmacovigilance, Procurement, R&D, and Compliance functions.

The programme is particularly valuable for individuals interfacing with software vendors, auditors, regulatory agencies, and cross-functional project teams responsible for implementing, managing, and maintaining validated computerized systems in GxP environments.

 Programme Module

Module 1: Quality, Quality Assurance and Quality Control in Pharmaceutical Industries

• Basics of Quality
• GMP Regulations: USFDA, EU, TGA, ICH, WHO
• Need of Quality
• Introduction to QA and QC

Module 2: Foundations of CSV

• Introduction to Computer System Validation
• Importance of Computer System Validation (CSV) in Pharma GMP & Quality
• Qualification & Validation
• Overview of regulated industries (Pharma, Biotech, Medical Devices)
• Key terminologies in CSV
• Evolution of validation practices
• Lifecycle approach in validation
• Introduction to GxP concepts
• Roles and responsibilities in CSV
• Overview of validation deliverables

Module 3: Regulatory Framework & Compliance

• Regulatory requirements for software validation – 21 CFR Part 11
• EU Annex 11 overview
• Comparison: US FDA vs EU regulations
• Quality certifications, Government regulations, ICH guidelines and ISO 9000
• Data integrity regulatory expectations (ALCOA++)
• FDA guidance on validation
• MHRA data integrity guidelines
• WHO validation guidance
• Regulatory inspection readiness
• Common regulatory observations (483s, warning letters)

Module 4: Software Development Life Cycle (SDLC)

• Software Development Life Cycle (SDLC)
• SDLC models (Waterfall, Agile, V-model)
• Validation in Agile environments
• Requirement gathering and analysis
• Functional and Design specifications
• Configuration management
• Change control in SDLC
• TestingstrategiesinSDLC
• Traceabilitymatrix
• SDLCdocumentation 

Module 5: GAMP 5&Documentation

• GAMP5 and documentation
• GAMP5 principles and framework
• GAMP categories of software
• V-model in GAMP5
• Supplier assessment and vendor audits
• Documentation lifecycle
• User Requirement Specification (URS)
• Functional Specification (FS)
• Design Qualification (DQ)
• Validation Master Plan (VMP) 

Module 6: Risk-Based Validation

• Risk based approach to software quality and Validation
• Introduction to risk management (ICH Q9)
• Risk assessment methodologies (FMEA, HACCP)
• Risk ranking and filtering
• Risk control strategies
• Risk review and monitoring
• Critical vs non-critical systems
• Impact assessment
• Risk-based testing approach
• Risk documentation 

Module 7: Testing & Qualification

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Test planning and protocols
• Test case design
• Test execution and deviation handling
• Regression testing
• User Acceptance Testing (UAT)
• Validation reporting
• Revalidation strategies
• Validation Master Plan
• Qualification Protocols: DQ, IQ, OQ, PQ, Calibration and Maintenance

Module 8: Data Integrity & Governance

• DataGovernance&Risk ManagementinDataIntegrity
• Datalifecycle management
• Dataintegrityprinciples (ALCOA++)
• Audittrailsandtheirimportance
• Digitalrecordmanagement,audittrails,andprocessmapping
• Electronicsignatures
• Datasecurityandaccesscontrols
• Backupanddisaster recovery
• Dataarchivalandretention
• Dataintegrityriskassessments 

Module 9: Audits & Inspection Readiness

• Software Quality Audit
• Types of audits (internal, external, regulatory)
• Audit planning and execution
• Audit trails review techniques
• Handling audit observations
• CAPA (Corrective and Preventive Actions)
• Inspection readiness strategies
• Mock audits and best practices
• Digital record management, audit trails, and process mapping

Module 10: Emerging Technologies & Digital Transformation

• DigitalTransformationwithAdvanced&EmergingTechnologies:AI/ML,dataintegrity by design
• IntroductiontoAI/ML inregulatedenvironments
• ValidationchallengesinAI/ML systems
• Dataintegritybydesignprinciples
• Cloud computing in CSV
• SaaS,PaaS,IaaSvalidationconsiderations
• Cybersecurityinvalidatedsystems
• Blockchainindataintegrity
• Industry4.0 andPharma4.0
• Digitaltwins in validation 

Module 11: Computer Software Assurance (CSA)

• New Approach to CSV – Computer Software Assurance (CSA)
• FDA CSA guidance overview
• Differences between CSV and CSA
• Critical thinking in CSA
• Risk-based assurance approach
• Documentation simplification in CSA 

Module 12: Automation & Advanced Systems

• Intelligent Automation & Robotic Systems
• Robotic Process Automation (RPA) in CSV
• Validation of automated workflows
• SCADA and PLC validation basics
• Laboratory Information Management Systems (LIMS) validation
• ERP systems validation (e.g., SAP)

Module 13: Industry based Case studies

• IndustrybasedCasestudiesinCSV(DataIntegrity,AuditTrails,etc.)
• Casestudy: FDAwarning letter analysis
• Casestudy: Data integrity breach
• Casestudy:Audittrail failure
• End-to-endvalidationproject walkthrough
• FuturetrendsinCSVandcareerpathways

Module 14: Capstone Project

Eligibility

Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma and Professional Certifications Programmes. 10+2 pass-outs are eligible for our Under Graduate Diploma and Diploma holders of two to three years course duration are also eligible for the PG Diploma.

Programme Duration

The minimum duration to complete the PG diploma programme is 12 months and maximum is 24 months. The minimum duration to complete the executive diploma programme is 6 months and maximum is 12 months.

Programme Mode

Registrations are currently open for regular and Part-time (Online Live Classes) both modes.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

• Assignments for all the programme modules for continuous evaluation and guidance.
• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• Part-time (Online Live Classes) for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
• All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• All learning and training delivery initiatives shall be conducted in English.

Examination & Certification

All the participants are obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will be awarded Post graduate Diploma/Executive Diploma in Computer System Validation by IGMPI. For all the above-mentioned modules, Part-time (Online Live Classes) or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. Details get updated on the webpage as well.

Discipline in Classes and Examination

Every student is required to observe a disciplined behaviour during her/his classes, assessments & examinations and to follow instructions from the Professors. Any act of indiscipline may result into discredit & it will be mentioned in her/his academic report.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionalsworking with global pharmaceutical like Cognizant, Accenture, Deloitte, Gland Pharma, Novo Nordisk, Pfizer, IQVIA, Baxter, Novartis India, Jubilant Generics Limited, Sun Pharmaceutical Industry, Merck Group, Bayer, Torrent Pharmaceutical Ltd., Eli Lilly & Co., GlaxoSmithKline, IPCA Laboratories, Tata Consultancy Services, Johnson & Johnson, Cipla Limited, etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future career prospects of Computer System Validation

Companies, particularly the life science industries must validate their information technologies (such as computer systems, software that run on them and infrastructure components) to ensure they meet the intended business needs. Computer System Validations involve activities primarily around generating requirements and specification documents, testing the systems against those specifications, documenting test results and writing final reports. There is definitely a bright career path if one is willing to learn about personnel process and technologies.
Computer System Validation field had enjoyed an explosive growth since the early 90’s. IT professionals, software vendors and developers, research, development and manufacturing associates and scientists, healthcare and clinical professionals, quality management professionals and technical project managers are dedicated to this field and the need is steadily growing as technology evolves and regulations increase. After completion of this programme, professionals can work as computer system validation specialist, validation engineer, validation consultant/analyst, QA consultant, IT validation analyst.

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Apply Online

Last date for submitting completed Application Form: 29^th May 2026.

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in