Data Integrity - Requirements for a GMP-compliant Data Life Cycle - Live Online Training
28-30 October 2026
Course No. 21649
Speakers
Dr Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Dr Franz Schönfeld
GMP Inspector
Attendees will get a free electronic copy of ECA “GMP Data Governance and Data Integrity Guide – Version 3”.
We offer you a discount of EUR 600 if you book this training course together with the full-day pre-course session Audit Trail Review from 27 October 2026.
Target Group
These Live Online Trainings are designed for
managers and staff from health care industries
managers and staff from suppliers
auditors who are responsible for the organisation and execution of Audit Trail (Reviews) and Data Integrity in their companies.
Objectives
Understand the current FDA and EU GMP regulations and guidance impacting data integrity from paper records to hybrid and electronic Systems
Understand the FDA, MHRA and WHO requirements for data Integrity
Learn what is required for a data governance system from senior management through to staff in laboratories, manufacturing and quality assurance
Understand the data life cycle and how it is linked with the business process and where problems can occur for both paper records, hybrid systems and electronic systems
Programme
Why is Data Integrity Important? – Setting the Scene
Summary of falsification observed by FDA and EU inspectors 2005 – to date
FDAISA act 2012 and October 2014 Guidance for Industry and the impact on inspections
Inspection of computerised systems is changing: from paper to on-line
MHRA expectation for data governance; data integrity guidance documents 2016
FDA Level 2 guidance on data integrity: 2010 and 2014 postings
Impact of WHO guidance for data integrity
Principles of Data Integrity
The ALCOA+ criteria for data integrity
Data life cycle in the process workflow – managing controls
Paper versus hybrid versus electronic systems
Validation of computerised systems for data integrity controls
Scope: production information versus laboratory data: why are laboratory data higher risk?
Faciliated Discussion / Workshop on Key Data Integrity Topics
Recording results on paper
Configuration of software applications
Unique user identities for all users
Unauthorised access
Appropriate access privileges for each user role
Is my chromatographic system ready? Role of “test” injections
Audit trails – options for older systems
Manual chromatographic integration
Standalone versus network systems
Protecting electronic records of standalone systems
Data Integrity – EU GMP Requirements
EU GMP Chapter 4 – documentation
EU GMP Annex 11 computerised systems
Data integrity definitions
Difference between paper and electronic systems
WHO, MHRA and GAMP Data Integrity Guidances - Key Points
Data Governance System within the Pharmaceutical Quality System
Data Life Cycle
Spectrum of Systems: Paper to Electronic Systems with data integrity audit
The GAMP Records and Data Integrity Guide
FDA Draft Guidance for Industry ‘Data Integrity and Compliance with cGMP’
Background
Questions and Answers regarding Data Integrity
Case Study: Analysis of an FDA Warning Letter
Trainers will analyse one of several FDA warning letters to identify key areas of regulatory concern
Data Integrity Questions as Part of an Inspection / Data Integrity Observations
Lab System
QA System
Manufacturing System
US 21 CFR 211 and EU GMP Chapter 4: Complete Data vs Raw Data vs Primary Record
Why complete data and raw data are important for understanding data integrity
EU GMP Chapter 4 requirements for raw data
21 CFR 211 requirements for laboratory records: complete data
FDA Level 2 guidance: paper versus e-records
Complete data / raw data / primary record example
Development and Scope of a Data Governance System
Within a PQS, what is the scope of a data governance system?
Who are involved?
What are their roles?
Implementing Data Integrity Training
Scope of data integrity training
What cover in the Training?
Checking training effectiveness
Integrating data integrity training with GMP Training
Role of Management in Data Integrity
Role of Senior, Production and Department Management in ensuring data integrity within an organisation and its suppliers
Data governance within a Quality System
Failures to address poor data integrity practices and no training
Case Study / Faciliated Discussion: Assessing a System for Data Integrity
Using a checklist based on the data integrity criteria, trainers will assess a system for data integrity
Data Integrity in Paper Documentation
GMP requirements for good documentation practice
Application to paper documents
Common problems from FDA 483 observations and warning letters and how to avoid them
Case Study: Can Spreadsheets meet Data Integrity Requirements?
Problems with spreadsheets
Good Practice for using spreadsheets in a regulated environment
Building data integrity features into a spreadsheet
User Account Management and Application Configuration
Separation of roles and responsibilities between IT and the business
Documentation of the configuration of an application e.g. audit trail, user types and access privileges
User account management: the dos and don’ts
User identities must be unique
Regular review of each system users and privileges
Software Suppliers Responsibility for Data Integrity Compliance
Regulatory requirements for software systems: procedural and technical
Role of software suppliers
Regulations push v market needs pull
Implementing technical requirements for software: architecture, database and application
Marketing literature versus marketing bullshit
IT Support for Data Integrity
IT facilities, environmental controls and physical security
Qualified IT infrastructure and validated IT systems
Backup and recovery / Change control
IT support including database administration
Impact of IT infrastructure on data integrity
Supply Chain Data Integrity – Organisational Interfaces
Approaches to ensuring data integrity of your suppliers
Role of technical agreements and audits
Further Information
Technical Information
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you Need to participate in our events and you can check if your System meets the necessary requirements to participate. If the Installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT)
Non-ECA Members EUR 2,490 ECA Members EUR 2,290 APIC Members EUR 2,390 (does not include ECA Membership) EU GMP Inspectorates EUR 1,245 The conference fee is payable in advance after receipt of invoice.
We offer you a discount of € 600 if you book this training course together with the pre-course session "Audit Trail Review" from 27 October 2026 here.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
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