Data Integrity Master Class with full-day pre-course session Raw Data
Im Auftrag der ECA Academy

Data Integrity Master Class with full-day pre-course session Raw Data Im Auftrag der ECA Academy

Berlin, Germany

Seminar Nr. 17292

This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager". Learn more.




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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Bob McDowall, R.D.McDowall Ltd.
Yves Samson, Kereon AG
Dr Franz Schönfeld, GMP Inspector
Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche Ltd.


Pre-coure Session "Raw Data"

The aim of this one day course is to understand what can be defined as raw data and to explore the meaning of the term for manufacturing, laboratory and quality records. Is there harmonisation of US and EU GMP regulations? For example:
  •  What is a “quality decision” and what is the impact of having to define raw data for the process or system?
  •  Can raw data be equivalent to complete information and complete data?
  •  Should we treat manufacturing “information” and laboratory “data” as the same?
Data Integrity Master Class
  • Your will get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements 
  •  You will get a deeper understanding what FDA and European  inspectors expects from pharmaceutical companies in regard to Data Integrity
  •  You will learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System
  •  You will learn how to prepare your company for an successful inspection in regard to Data Integrity
  •  You will understand how to establish an effective Data Governance system
  •  You will learn how to investigate Data Integrity issues  in your company


Pre-course Session "Raw Data"

FDA GMP in 21 CFR 211 requires “complete information” for manufacturing records and “complete data” for laboratory records. In contrast, Chapter 4 of EU GMP on documentation contains in the Principle three sentences that are in apparent contradiction to the United States regulations:
  •  Records include the raw data which is used to generate other records
  •  For electronic records regulated users should define which data are to be used as raw data
  •  At least, all data on which quality decisions are based should be defined as raw data
In the days of harmonisation of regulations how can we reconcile these differences? This situation is compounded by the failure of EU GMP to define the term “raw data” in the regulations to help industry plan their approach to meeting these regulatory requirements.

Data Integrity Master Class

Even Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue be the focus of many GMP inspections.

As a consequence international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe  the regulatory expectations of  Data Integrity.

Although all guidelines are not intended to impose additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry how to implement these requirements into the daily Business.


The courses are directed at
  •  Managers and staff from Manufacturing, QC/QA and Analytical Development Laboratories of pharmaceutical companies
  •  Contract Research Organisation and Contract Manufacturing Organisation manufacturing, laboratory and QA personnel
  •  Auditors (internal and external) responsible for performing self-inspections or external audits and needing to understand and assess data integrity
Especially the Data Integrity Master Class course is directed to participants who have first experiences in Data Integrity, e.g. the ECA course “Data Integrity – Requirements for a GMP compliant Data Life Cycle".


Pre-course session "Raw Data - Understanding, Defining and Managing"
Data, Information and Knowledge - An overview presentation covering for production, laboratories and QA. Link to regulations e.g,
  • Data, information and knowledge
  •  US GMP regulations: 211.68(b), 211.180(d), 211.188 and 211.194(a-e): complete data and complete information
  •  EU GMP Chapter 4 regulations – raw data principles outlined from a GMP perspective
Cutting Through the Confusion and Fog of Regulatory Terms
Currently there are many terms used in GMP regulations and data integrity guidance documents. What do they mean? How are they relevant to debate?  Definition and interpretation of
  •  Original record / record
  •  Raw data – MHRA GMP and US GLP definitions
  •  Data and metadata
  •  True copy
  •  Complete data
  •  Initial data
  •  Translating raw data for a GMP environment: should we treat manufacturing and laboratory the same when it comes to raw data?
Interpretation of Raw Data for Production Systems
Using a manufacturing process that is automated by standalone PLCs, PLCs linked to a SCADA system and an automated Manufacturing Execution System, what constitutes raw data will be outlined.
  •  Raw Data for PLCs
  •  PLCs linked to a SCADA system
  •  SCADA linked to a Manufacturing Execution System
Interpretation of Raw Data for Laboratory Systems
Using a process involving a chromatography data system and a LIMS, what constitutes raw data will be outlined in two scenarios
  •  Hybrid CDS and manual input to the LIMS
  •  Electronic CDS with automatic transfer to the LIMS
  •  Managing sample management and preparation records
Workshop: Defining Raw Data for Production, QA and Laboratory Systems
This workshop is intended to reinforce the two previous presentations. Attendees will be given laboratory, quality assurance and production scenarios to define raw data. Outputs will be discussed with the course

Can a True Copy be Raw Data?
  • This brief presentation will start from the definitions of raw data and true copy and explore if and how a true copy can be considered raw data.
Workshop : What are Raw Data for quality decisions
  • Identifying GMP quality decisions?
  •  For each quality decision – define the raw data
Data Integrity Master Class

Regulatory Update
  •  EU GMP Requirements
    •  Chapter 4
    •  Annex 11
  •  Guidance Documents Overview (state of the art)
    •  GMDP Inspectors WG, Data Integrity Q&A
    •  (PIC/S Good Practices for Data Management and Integrity in regulated GMP/GDP Environments)
    •  WHO, Annex 5 Guidance on Good Data and Record Management Practices
    •  MHRA GxP Data Integrity Definitions and Guidance for Industry
    •  FDA, Data Integrity and Compliance with cGMP
  •  “These Guides are not intended to impose additional regulatory burden upon regulated entities”. Is This  correct?
    •  Data Governance
    •  Dynamic Data
Data Integrity in the pharmaceutical quality system / Data Governance
  •  Which PQS elements need to be added or updated?
  •  The Data Integrity Program
    •  Priorities (immediate/short/mid-term)
    •  Capacity
    •  Timing
  •  Governance responsibilities
  •  Data governance vs. IT governance
  •  Elements of a data governance
  •  Embedding data governance into the PQS
Data flow analysis
  •  Objective and purpose
  •  Electronic data flow
  •  Complete data flow
  •  Identification of possible weaknesses
Workshop on Data Flow Analysis
  • Identification of data flow weaknesses and non-compliances
Metrics for Data Integrity
  •  Metrics in the context of a corporate data integrity programme
  •  Suggested metrics in the assessment phase
  •  Suggested metrics in the operational phase
  • Control of Master Templates and Blank Forms
  •  Why is control of master templates and blank forms important?
  •  Regulatory requirements from FDA, MHRA, WHO, EMA and PIC/S
  •  Devising and controlling the master template
  •  Operational use of the blank forms
  •  Do you really want to work this way?
DI Inspections
  •  Basis for Inspections: “PIC/S Good Practices for Data Management and Integrity in regulated GMP/GDP Environments”
  •  Data Integrity Assessment during Inspection
    •  Quality Control
    •  Manufacturing
  •  Inspection Findings
Preparing your company for an Data Integrity inspection
  •  How to present the DI status and future approach?
  •  Gap analysis
  •  Training program coverage
  •  Experience from FDA inspections – Hot Buttons
Second Person Review
  •  Regulatory and guidance document requirements for the second person review
  •  Role of the second person review
  •  Scope of the second person review
  •  Documenting the review for paper, hybrid and electronic systems
  •  Facilitated discussion on Second Persons Review
Quality Culture for Data Integrity
  •  Regulatory expectations for a data integrity quality culture
  •  Role senior management in creating the culture
  •  Components of a quality culture
  •  Reinforcement of the culture
QA oversight for data integrity
  •  Data integrity training
  •  Enforce data flows
  •  Reviews
  •  Internal inspection
  •  Audit of external organisations
Workshop on QA Oversight for Data Integrity
  • Identification of QA oversight weaknesses
Vulnerability of Records
  •  What is record vulnerability?
  •  Protection and security of electronic records requirements
  •  What can go wrong?  Scope of misfortunes that can impact records
  •  Assessment of record vulnerability and implementation of control measures
Workshop on Vulnerability of Records
  • Working in teams, the attendees will be presented with a scenario of a computerised system that generates electronic records.  They will assess the record vulnerability and determine the controls to put in place to protect the records and ensure data integrity.  Team outputs will be discussed with all participants.
Audit trail review
  •  Regulatory Overview
  •  Essential Audit Trails in QA/QC/Manufacturing. Risk-based approach.
  •  What about legacy systems w/o Audit Trail?
  •  Who shall review Audit Trails? Documentation
  •  What process and documentation is appropriate in case of deviations/discrepancies?
Options for Long Term Data Retention of Laboratory Data
  •  Proprietary v open standards for laboratory data
  •  Options for long term retention:
    •  Keep original system, Virtualisation, Data migration
Case study Data Migration
  •  Principles of data migration
  •  Design of the migration process
  •  Risk-based elaboration of the verification strategy – case study examples
Cybersecurity / Cloud Computing / Time synchronisation
  •  Cybersecurity securing data integrity
  •  Robust IT infrastructure
  •  Time synchronisation
  •  Qualification of time dissemination
Results of a Data integrity audit from a contract laboratory
  •  Audit context, Audit scope, Findings, Root causes
Data Integrity Investigations
  •  What are data integrity investigations?
  •  Human and technical triggers for DI investigations
  •  Who should investigate the problem?
  • Process description and how to document a DI investigation
  • Should we inform regulatory authorities?
Workshop on Data Integrity Investigations
Based on a case study, attendees will be presented with key facts and determine what an organisation should do to investigate a data integrity issue.  At the end of the workshop, during the discussion of the team outputs there will be a comparison with the work performed in the case study.


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