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Postgraduate DiplomaRobotics, Automation & Control Applications open

Diploma in GxP/GAMP5 and Data Integrity

Online postgraduate diploma of 800 hours in GxP/GAMP 5 and data integrity: 8 modules covering GxP practices, the GAMP 5 approach, validation of automated systems, data integrity, technical integrity controls, change control and inspections under ISPE GAMP 5 Second Edition, FDA 21 CFR Part 11 and EudraLex Volume 4 Annex 11, with an assigned technical tutor.

Duration6–8 months
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma
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Diploma in GxP/GAMP5 and Data Integrity — studying from India

India's automation and robotics market is growing with the expansion of manufacturing, automotive and electronics production. Industrial automation firms such as ABB, Siemens, Fanuc and Bosch operate in the country, alongside domestic integrators and start-ups in Bengaluru, Pune, Chennai and Hyderabad. Research institutions including the Indian Institute of Science and several IITs contribute to robotics and control research. Standards for industrial machinery and safety draw on the Bureau of Indian Standards. Engineers in this area design control systems, robotic cells, automation solutions and programmable logic controllers for factories and warehouses.

Fees for India: ₹137,000 (Indian Rupee), with instalments and employer sponsorship available.

Relevant bodies in India

  • Bureau of Indian Standards (BIS)
  • Indian Institute of Science (IISc)
  • Indian Institute of Technology (IIT) robotics research groups
  • Automation and Robotics Industry associations

Typical roles

  • Robotics Engineer
  • Control Systems Engineer
  • Automation Engineer
  • PLC Programmer

Questions from India

Is there a professional body in India that recognises robotics and automation engineers?

Robotics in India has no separate statutory title. The Institution of Engineers (India) is the main general engineering body, and technical standards come from the Bureau of Indian Standards. SEIUM's qualification is private and not accredited by any national body, so recognition rests with employers and the relevant body.

Which employers in India hire robotics and automation engineers?

Automotive plants, electronics manufacturers, factory automation suppliers, logistics firms, and robotics startups are typical employers. Hiring focuses on skills and project experience. The qualification can support a profile, but employers decide how much it counts and no outcome is guaranteed.

Can I study robotics online from India while working, and what language?

Yes, the programme is 100% online, so you can study from anywhere in India without a student visa and fit it around work. It is taught in English, so you need a reasonable level of the language. Each student has an assigned technical tutor, fees can be paid in instalments, and employer sponsorship is possible.

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Learning outcomes

What you will be able to do

01

Explain the GxP requirements applicable to automated systems.

02

Apply the risk-based approach of GAMP 5 Second Edition.

03

Validate PLC, SCADA, MES and LIMS systems in regulated environments.

04

Interpret ALCOA+ principles and data integrity guidance.

05

Implement technical controls for audit trails, access and electronic signatures.

06

Maintain the validated state through change control and periodic review.

07

Prepare evidence for data integrity audits and inspections.

Profile

Who it's for

  • Computerised systems validation specialists.
  • Data integrity managers.
  • GxP consultants.
  • Pharmaceutical automation engineers.
  • GxP quality auditors.
  • Quality information systems managers.
  • Engineering or science graduates seeking to move into the pharmaceutical industry.
Standards & tools

What you'll work with

  • ISPE GAMP 5 Second Edition (risk-based approach to GxP computerised systems)
  • FDA 21 CFR Part 11 (electronic records and signatures)
  • EudraLex Volume 4 Annex 11 (computerised systems)
  • MHRA GxP Data Integrity Guidance 2018 (data integrity expectations)
  • PIC/S PI 041-1 (good practices for data management and integrity)
  • ISPE GAMP Good Practice Guide: Data Integrity by Design (integrity built into system design)
  • ICH Q9(R1) (quality risk management)
  • WHO TRS 1033 Annex 4 (data and records management)
  • Kneat Gx
  • ValGenesis VLMS
  • Siemens SIMATIC WinCC with Audit
  • Rockwell FactoryTalk AssetCentre
  • LabWare LIMS
Syllabus

8 modules

  1. 1.1The GxP family: GMP, GLP, GCP and GDP
  2. 1.2Origin and purpose of GxP regulations
  3. 1.3Pharmaceutical quality system
  4. 1.4Responsibilities of the qualified person
  5. 1.5Impact of automation on GxP
  6. 1.6Computerised systems with GxP impact
  7. 1.7System criticality assessment
  8. 1.8Regulatory agency expectations
  9. 1.9Consequences of non-compliance
  10. 1.10Case study: GxP inventory of a plant’s systems
  1. 2.1ISPE GAMP 5 Second Edition
  2. 2.2Critical thinking and the risk-based approach
  3. 2.3Software categories 1, 3, 4 and 5
  4. 2.4Computerised system lifecycle
  5. 2.5User, functional and design specifications
  6. 2.6Leveraging supplier documentation
  7. 2.7Agile methods in GxP environments
  8. 2.8FDA Computer Software Assurance
  9. 2.9Scaling effort according to risk
  10. 2.10Workshop: GAMP classification of ten plant systems
  1. 3.1System validation plan
  2. 3.2Functional risk assessment
  3. 3.3Configuration and customisation testing
  4. 3.4Validation of PLC, SCADA and DCS
  5. 3.5Validation of MES and LIMS
  6. 3.6Management of interfaces between systems
  7. 3.7Spreadsheet validation
  8. 3.8Validation report and release
  9. 3.9Maintaining the validated state
  10. 3.10Practical exercise: functional risk matrix for a SCADA system
  1. 4.1ALCOA+ principles
  2. 4.2MHRA GxP data integrity guidance
  3. 4.3PIC/S PI 041 guidance
  4. 4.4Data lifecycle
  5. 4.5Original data, metadata and true copies
  6. 4.6Static and dynamic data
  7. 4.7Integrity risks in automation
  8. 4.8Integrity culture and behaviour
  9. 4.9Data fraud and manipulation
  10. 4.10Case study: analysis of a warning letter for data integrity
  1. 5.1Audit trail and its review
  2. 5.2Electronic signatures and their linking
  3. 5.3User and privilege management
  4. 5.4System time synchronisation
  5. 5.5Backups and archiving
  6. 5.6Protection against deletion and overwriting
  7. 5.7Control of data exports
  8. 5.8Secure configuration of legacy systems
  9. 5.9Integrity in standalone devices
  10. 5.10Laboratory: audit trail review of a SCADA system
  1. 6.1Change control in validated systems
  2. 6.2Incident and deviation management
  3. 6.3Configuration management
  4. 6.4Periodic review
  5. 6.5Patch management and GxP cybersecurity
  6. 6.6Cloud infrastructure and suppliers
  7. 6.7Business continuity and recovery
  8. 6.8System retirement and data migration
  9. 6.9Training and competence
  10. 6.10Practical exercise: impact assessment of a patch on a validated system
  1. 7.1Internal data integrity audits
  2. 7.2Software supplier audits
  3. 7.3Typical inspection questions
  4. 7.4Demonstrating controls to the inspector
  5. 7.5Common findings in automation
  6. 7.6Remediation plans
  7. 7.7Compliance indicators
  8. 7.8Communication with management
  9. 7.9Improving the quality system
  10. 7.10Case study: mock data integrity inspection
  1. 8.1Selection of the computerised system
  2. 8.2Impact assessment and GAMP category
  3. 8.3Requirements specifications
  4. 8.4Functional risk assessment
  5. 8.5Test strategy
  6. 8.6Data integrity controls
  7. 8.7Operation and maintenance plan
  8. 8.8Compliance assessment
  9. 8.9Report and presentation
  10. 8.10Final project: final review with the tutor
Methodology, software & labs

How you'll learn

Training is 100% online on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: you progress at your own pace within each intake, making it compatible with work.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is Kneat Gx, ValGenesis VLMS, Siemens SIMATIC WinCC with Audit, Rockwell FactoryTalk AssetCentre and LabWare LIMS, in free, academic or evaluation versions. Tests are studied on real procedures: GAMP classification and validation of a SCADA system, audit trail review for data integrity, and a mock regulatory inspection. Assessment is continuous by module plus the final project.

Standards covered: ISPE GAMP 5 Second Edition, FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11, MHRA GxP Data Integrity Guidance 2018, PIC/S PI 041-1, ISPE GAMP Good Practice Guide: Data Integrity by Design, ICH Q9(R1), WHO TRS 1033 Annex 4.

Assigned technical tutor:every module ends with a deliverable that your tutor marks individually.
Standards-based learning:guided reading of GAMP 5 Second Edition, FDA 21 CFR Part 11, EudraLex Annex 11 and the MHRA data integrity guidance applied to real cases, not as a theoretical annex.
Industry software:Kneat Gx, ValGenesis VLMS, Siemens SIMATIC WinCC with Audit, Rockwell FactoryTalk AssetCentre and LabWare LIMS, in free, academic or evaluation versions.
Final project:GAMP validation of a computerised system, from impact assessment and requirements to test strategy and data integrity controls, reviewed by your tutor.
Flexible format:100% online, no fixed timetables, compatible with full-time work.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

Impact assessment and categorisation
Select a computerised system and assess its GxP impact and GAMP category.
Requirements and risk
Write the requirements specifications and carry out the functional risk assessment.
Test strategy
Define the risk-scaled test strategy for the system.
Data integrity controls
Specify audit trail, access and electronic signature controls plus the operation and maintenance plan.
Final project
Assess compliance and present the validation report to your tutor.
Career opportunities

Where this takes you

Computerised systems validation specialistData integrity managerGxP consultantPharmaceutical automation engineerGxP quality auditorQuality information systems manager
Admissions & scholarships

Requirements

  • Prior technical training or professional experience in the sector. No university degree is required.
  • Internet connection and a computer capable of running the programme software.
  • English sufficient to read technical standards.

Ready to start?

Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.

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FAQ

Frequently asked questions

The programme totals 800 hours over 6–8 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.

You work with Kneat Gx, ValGenesis VLMS, Siemens SIMATIC WinCC with Audit, Rockwell FactoryTalk AssetCentre and LabWare LIMS, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.

A SEIUM Institute diploma, awarded on passing the continuous assessment and the final project. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.

Yes. Modules passed are recognised in a higher programme in the same area (postgraduate diploma or master's). Ask about the recognition policy when you enrol.

Prior technical training or professional experience in the sector (no university degree required), a computer capable of running the software, and English sufficient to read technical standards.

Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.

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