Data integrity, electronic records and signatures

1 Day/s

CPD Hours: 7

Online, in-house

This course covers the key concepts of Record and Data Integrity and Electronic Records and Signatures, including the key regulatory requirements and expectations (including Annex 11 and Part 11, and related guidance), example citations, and pragmatic industry good practice.


  • Regulators and Health Agencies are continuously stressing the importance of the topic
  • Data Integrity is a significant theme in many recent regulatory citations
  • Record and data integrity are an essential part of the pharmaceutical quality assurance system and essential to operating in compliance with GxP requirements
  • A secure foundation of data integrity is vital to protect the quality of the product and the safety of the patient

Anyone involved in GxP IT, manufacturing systems, laboratory systems, and IT infrastructure. This includes any IT or related service providers (including cloud providers), and providers of software products, or computerized systems and equipment to life science companies.


For example; Validation professionals, IT, Engineering, Quality Assurance, Qualified Persons, Quality Control, Process Owners including manufacturing, laboratory, clinical, PV and GxP other processes), System Owners, Project Managers, and consultants.

This course covers the following topics:


  • Definitions and key concepts
  • Applicable regulations (annex 11, Part 11)
  • Regulatory guidance – and what they mean in practice
  • Data audit trail and data audit trail review
  • Regulatory citations and how to avoid them
  • Industry good practice
  • Data governance
  • The data life cycle
  • Achieving compliance in an effective way
  • Application of ideas and concepts to your systems

    By the end of the course, you will understand:

    • Definitions and key concepts
    • Applicable regulations (annex 11, Part 11)
    • Regulatory guidance – and what they mean in practice
    • Data audit trail and data audit trail review
    • Regulatory citations and how to avoid them
    • Industry good practice
    • Data governance
    • The data life cycle
    • Achieving compliance in an effective way
    • Application of ideas and concepts to your systems
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Meet the tutors

Sion Wyn

Sion is an acknowledged expert in computer system validation and compliance and international regulations in this field. He assisted the FDA as a consultant with its re-examination of 21 CFR Part 11 and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He received the FDA Group Recognition Award for work on Part 11.

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