Data Integrity - Requirements for a GMP-compliant Data Life Cycle
6-8 May 2026, Berlin, Germany
Course No. 22287
Speakers
Dr Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Dr Franz Schönfeld
GMP Inspektor
If you book this course together with the full-day pre-course session "Audit Trail Review", we will offer you a discount of € 600,-
Target Group
This course is designed for managers and staff from health care industries as well for auditors who are responsible for the organisation and execution of audit trail (reviews) 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 requirements for data integrity, MHRA Data Integrity guidance and WHO guidance.
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.
Background
Data Integrity is a global problem and currently still a major concern with FDA and European Regulatory Agencies. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification in companies globally. The regulatory concern has been responded by the FDA issuing Compliance Program Guide that covers Pre-Approval Inspections.
In Europe, the UK’s MHRA issued a new version of a Guidance for Industry on Data Integrity in March 2018. This document outlines a data integrity governance system and principles for defining quality and data integrity into processes and systems. The WHO guidance is complimentary to the MHRA guidance in that it provides guidance for data governance and also expectations for records in both paper and electronic form..
As the regulators are tightening their inspection approaches it is important that managers, supervisors and users in regulated GMP laboratories understand the issues around data integrity and begin programs to ensure that their processes and systems ensure data integrity.
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?
Facilitated 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 – (new) EU GMP Requirements
EU GMP Chapter 4 – documentation
EU GMP Annex 11 computerised Systems
Data integrity definitions
Difference between paper and electronic Systems
Key Points from Data Integrity Guidances
MHRA, WHO, FDA data integrity Guidelines
PDA, TR 80, APIC guides
The GAMP Records and Data Integrity Guide
Workshop: Analysis of an FDA Warning Letter
Working in teams, attendees will analyse an FDA warning letters to propose controls to prevent them from occurring
Group discussion of regulatory concerns identified
Case Study: Data Integrity Questions as Part of an Inspection
Lab System
QA System
Manufacturing System
US 21 CFR 211 and EU GMP Chapter 4: Complete Data vs Raw Data
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 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 ist suppliers
Data governance within a Quality System
Failures to address poor data integrity practices and no training
Workshop: How to Write Testable Requirements for Data Integrity
Access Control
Archiving
Technology constraints
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
Workshop: Assessing a System for Data Integrity
Using a checklist based on the data integrity criteria, attendees will assess a system for data integrity
Case study: Can Spreadsheets meet Data Integrity Requirements?
Problems with spreadsheets
Good Practice for using spreadsheets in a regulatedenvironment
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
Key Learning Points and Final Discussion
Summary of Data Integrity Requirements and Key Learning Points
Final Discussions and close of the course
Further Information
Venue DoubleTree by Hilton Berlin Ku´Damm Los-Angeles-Platz 1 10789 Berlin, Germany Phone +49 (0) 30 2127 714 Email alexander.kliche@eventhotels.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT) ECA Members € 2,290 APIC Members € 2,390 Non-ECA Members € 2,490 EU GMP Inspectorates € 1,245 The conference fee is payable in advance after receipt of invoice and includes conference documentation, social event and dinner on the first day, lunch on day 1 and day 2 and all refreshments. VAT is reclaimable.
You will save € 600 by booking both the Data Integrity and the Audit Trail Review Course!
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Social Event On 6 May, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Contacts Questions regarding content: Dr Andreas Mangel (Operations Director), +49(0)62 21 84 44 41, mangel@concept-heidelberg.de.
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