Document Management and Data Integrity (London, United Kingdom - March 23, 2018) - Research and Markets

The "Document Management and Data Integrity" conference has been added to Research and Markets' offering.

Data Integrity is a critical issue in document governance. Document Management and Data Integrity are increasingly becoming a focus for regulatory inspections globally. This course will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

Data Integrity issues can apply to all life science industry sectors where data is required to fulfill regulatory requirements, including clinical trials, pharmacovigilance and manufacturing. This concise course will provide an essential understanding of the requirements for ensuring data integrity and effective Document Management in order to maintain compliance with the new regulatory requirements in this area.

Topics to be covered Include:

  • Principles of Good Documentation Practice (GDP) and data integrity
  • Compliance with Good Documentation Practices for linked paper and electronic records
  • Regulatory guideline requirements in the EU, UK, FDA and WHO


Introduction & Welcome

Principles of Good Documentation Practice and Data Integrity

  • What is Data Integrity?
  • Why is Data Integrity important?
  • ALCOA principles
  • Good Documentation Practice


  • MHRA / WHO / FDA / EMA / PICS/ ICH GCP R2, Data Integrity guidelines
  • Group review and discussion of some key regulated documents

QMS considerations for documentation and ensuring Data Integrity

  • What are the elements of QMS
  • Risk management considerations
  • Discussion of participants experience and best practice

Data Integrity for computer systems

  • Data flow and risk considerations
  • Steps for compliance

Discussion of document management and Data Integrity issues including

  • Good Documentation Practices for linked paper and electronic records
  • Records - Life Cycle and Data Integrity issues
  • Control Mechanisms
  • Validation for electronic documentation
  • Data Integrity and digital signatures
  • Data Integrity Governance Plans
  • Certified copies/true copies
  • Archiving

Case Study: PhelxGlobal - practical experience of the electronic TMF and Data Integrity

Document management and Data Integrity inspection findings

  • MHRA, EMA findings, EU Non-Compliance Reports
  • FDA finding
  • Group experiences of inspection and audit

Final Discussion

Close of Meeting

For more information about this conference visit