Ensuring Data Integrity in Pharmaceutical Operations

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Course Overview


Data integrity has been a focus for pharmaceutical regulatory inspections for several years. Many inspection reports from regulatory agencies such as the FDA and EMA cite data integrity as a cause of observations and enforcement action. In serious cases regulators ceased commercial activities of manufacturers on the grounds of data integrity violations.


This data integrity training course explains the background to data integrity regulations and sets out the expectations of pharmaceutical regulators. It will provide you with the knowledge and practical skills to implement data integrity best practice. Ultimately the aim of this course is to minimise any data integrity issues or violations by maintaining high quality data integrity processes. The course explains how to take a risk-based approach to data integrity compliance, electronic record keeping (GAMP 5) ALCOA for pharmaceutical records and conducting your own data integrity audits.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives


  • Understand what data integrity is and why it is important for patient safety and product quality.
  • Recognise that there are many causes of data integrity breaches.
  • Be aware of current regulatory expectations such as GAMP 5 and ALCOA.
  • Appreciate the difference between static and dynamic records and be able to apply acceptable strategies for the retention of both types of record.
  • Be able to categorise and validate GxP computerised systems according to GAMP 5.
  • Understand the importance of training and quality culture in avoiding regulatory enforcement action.
  • Learn how to respond to data integrity observations in inspection reports.
  • Discover how to prevent, detect and remedy data integrity problems
Post Learning Implementation Plan (PLIP)


  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Day 1

Historical background and data integrity definitions

  • Data integrity and patient safety/product efficacy
  • The evolution of GxP regulations – driven by both criminal activity and honest mistakes
  • The US FDA’s debarment policy
  • Evolution of data integrity guidances
  • Introduction to GAMP 5
  • Early data integrity cases


Regulatory expectations

  • ALCOA and ALCOA+
  • Static and dynamic records
  • Essential elements of data governance
  • Non-conformance trends
  • Data integrity controls
  • Data integrity risks in sample analysis and production
  • Investigating data integrity problems
  • Metadata, audit trails and audit trail review


Data integrity risk assessment

  • Quality risk management: ICH Q9
  • Risk management process
  • Approaching a data integrity risk assessment
  • Controlling risk in computerised systems
  • Configuration and life cycle management
  • Operating system and application software considerations


Computerised systems

  • Audit trails, access controls and user permissions
  • Excel spreadsheets – practical advice on the appropriate use, validation and control of Excel spreadsheets
  • Introduction to computerised data system validation


Extracts from regulatory enforcement letters


Addressing data integrity problems


Day 2

Managing computerised data systems

  • Guidance
    • 21 CFR Part 11
    • EU Annex 11
    • GAMP 5
  • Examine the detailed practices recommended by GAMP 5
  • Life cycle management and risk assessment
  • Supplier assessment


Computerised system validation

  • Validation planning
    • Policy
    • Plans
    • Documentation
  • System description
  • Introduction to software testing


Conducting a data integrity audit

  • Planning the audit
  • Conducting the audit
    • Policies, procedures, practices
    • Training
    • Quality culture
  • Evaluating quality risk
  • Mitigating data integrity risks


Managing client audits and regulatory inspections

  • The importance of data integrity risk assessments/action plans
  • The audit/inspection process
  • Client audits
    • Confidentiality
    • Result checking and reporting
  • Regulatory inspections
    • Behaviour during inspection
    • Responding to non-conformance observations

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff.


In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, dissolution testing, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.


Mark has delivered numerous training courses on data integrity, helping professionals and organisations to understand the latest guidances and implement best practice. He provides expert advice in all areas of data integrity such as regulatory guidances, audits, GAMP 5 and risk assessments. He has conducted data integrity audits in the UK, continental Europe and the United States. Mark draws on his extensive experience and provides multiple examples throughout the course. He has recently co-authored a data integrity guide in collaboration with the laboratory supplier and instrument manufacturer VWR.

This course is aimed at professionals who work with data in a regulatory GxP environment such as the pharmaceutical, biotech or medical device industries. These include: Quality | Laboratory Personnel | Production Personnel | Analysts | IT/IS Managers | Regulatory Affairs | Documentation Departments.


The following sectors would benefit from this course: Pharmaceutical | Biotechnology | Medical Devices | API Manufacturers | Contract Laboratories | Clinical Research Organisations.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.