Data Integrity - Requirements for a GMP-compliant Data Life Cycle - Online Training Recording
Course No. 20325A
Speakers
Dr. Bob McDowall
R.D. McDowall Ltd.
Dr. Franz Schönfeld
Regierung von Oberfranken
Yves Samson
Kereon
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 July 2016 and WHO guidance from September 2015.
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 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. This document became effective in May 2012. The CPG objective 3 covers the laboratory data integrity audit. Furthermore in August 2014, the FDA issued Level 2 guidance on their web site about the sharing of login credentials for computerized systems and the use of test injections for testing into compliance.
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.
Target Group
This Online Training 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.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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?
Case Study / Faciliated Discussion 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
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
Key Learning Points / Final Discussion
Recording from 7-9 December 2022 Duration of the recording: approx. 12 h 17 min
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager" Learn more
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