Data Integrity Master Class
Im Auftrag der European Compliance Academy

Data Integrity Master Class Im Auftrag der European Compliance Academy

Berlin, Germany

Seminar Nr. 15944


Die Veranstaltung hat bereits stattgefunden

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


Bob McDowall, R.D.McDowall Ltd.

Yves Samson, Kereon AG

Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche Ltd.

Dr Arno Terhechte, Bezirksregierung Münster


  • 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.


Even Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations were reported by FDA and 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 to 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 Data Integrity Master Class is 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


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
  • Which PQS elements need to be added or updated?
  • The Data Integrity Program: Priorities (immediate/short/mid-term), Capacity, Timing
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
Data flow analysis
  • Objective and purpose
  • Electronic data flow
  • Complete data flow
  • Identification of possible weaknesses
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
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
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
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 Person review
Time synchronisation
  • Purpose and requirements
  • TAI, UTC, time zone, legal time, local time, system time
  • ntp - network time protocol
  • Time management concept
Software Suppliers Responsibility for Data Integrity Compliance
  • Regulatory requirements for software systems:
  • procedural and technical
  • Role of software suppliers
  • Regulations push vs market needs pull
  • Implementing technical requirements for software: architecture, database and application
  • Marketing literature versus marketing bullshit
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?
Risk-based approach for manufacturing and laboratory audit trail review
  • Regulatory requirements and expectations for audit trail review
  • Is the application adequate for audit trail review?
  • Application of a risk based approach to audit trail review
Workshop on Audit Trail Review
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

QA oversight for data integrity
  • Data integrity training
  • Enforce data flows
  • Reviews
  • Internal inspection
  • Audit of external organisations

Cyber security measures to assure data integrity
  • Cyber security reality and concerns
  • Possible security weaknesses
  • Designing robust IT and automation infrastructures
Data governance
  • Governance responsibilities
  • Data governance vs. IT governance
  • Elements of a data governance
  • Embedding data governance into the PQS
Data integrity audit results of a contract laboratory
  • Audit context
  • Audit scope
  • Findings
  • Root causes
Case study Data Migration - Production
  • Migration of complex data collections
  • Migration of a large collection of similar data
  • Design of the migration process
  • Risk-based elaboration of the verification strategy
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
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

Key Learning Points and Final Discussion


GMP Seminare nach Thema

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