Professional Certification in Data Integrity

A Professional Certification in Data Integrity equips professionals with the knowledge and skills to ensure the accuracy, completeness, consistency, and reliability of data across regulated industries such as pharmaceuticals, biotechnology, and medical devices. The program typically covers modules on data governance principles, ALCOA+ framework (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available), 21 CFR Part 11 compliance, Good Documentation Practices (GDP), audit trails, risk-based approaches to data integrity, computer system validation (CSV), data lifecycle management, and regulatory requirements from FDA, EMA, WHO, and MHRA. Participants learn to design and implement robust data integrity controls, perform internal audits, and address findings during regulatory inspections. Career opportunities span quality assurance, regulatory affairs, compliance auditing, CSV/CSA roles, and data governance consulting, with increasing demand due to stricter global regulations and the integration of digital systems in GxP environments.

Programme Structure

Module 1: Good Manufacturing Practices and its Regulations

Module 2: Good Documentation Practices and Record Keeping

Module 3: Computer System Validation (CSV) - Overview, Regulatory requirements (GAMP & 21 CFR Part 11) and documentation

Module 4: Importance and Principle of Data Integrity

Module 5: Developing the Data Integrity Plan and Guidance document on Data Integrity

Module 6: Data Governance & Risk Management

Module 7: Computer Software Assurance (CSA)

Module 8: Digital Transformation with Advanced & Emerging Technologies: AI/ML, data integrity by design

Module 9: Digital record management, audit trails, and process mapping

Module 10: Data integrity in Intelligent Automation & Robotic Systems- Robotic Process Automation (RPA)

Module 11: Case Studies

Eligibility

Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma and Professional Certification Programmes.

Programme Duration

The minimum duration to complete the Professional Certification programme is 6 months and maximum is 12 months.

Programme Mode

Registration is currently open for Part-time (Online Live Classes) mode.

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.
• Online Live Classes/Part-time 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

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Professional Certification Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

All the participants are expected to appear for online exam and are also obliged to submit assignments after each module. After successful completion the participants will be awarded Professional Certification in Data Integrity by IGMPI. For all the above mentioned modules elaborate course material, assignment and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in 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 professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon 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 and Food industries on regular basis.

Future career prospects

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. Data Integrity 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.

Data Integrity 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 course, professionals can work as computer system validation specialist, data integrity specialist, validation engineer, validation consultant/analyst, QA consultant, IT validation analyst.

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Apply Online

Last date for submitting completed Application Form: 11:59 PM 16^th Sep 2025.

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