DATA INTEGRITY

Our goal is to help you pass the inspection of regulatory bodies (WHO, FDA, State Medical Service, PIC/S) in terms of data integrity. We will develop and effectively implement a data integrity policy for you at all levels: from employees to top management.

As inspectors of the State Service of Ukraine for Medicines and Drug Control, FDA, WHO increase their attention to data integrity issues, it is becoming increasingly difficult for companies to ensure that their data and record management methods meet regulatory requirements.

In recent years, data integrity issues have become an international epidemic in the field of GxP.

We have experience working with global experts in data integrity representing ISPE, USP and WHO. Our experts are the official reviewers of ISPE's Good Data Practice Guide: GAMP RDI Good Practice Guide: Data Integrity by Design. That is why we are at the forefront of the requirements and clearly understand the expectations of inspectors. We will solve such problematic issues for you as:

  • Data criticality assessment and data-mapping
  • Storage data on devices that are not connected to the network
  • Proper organization of data backup and recovery
  • Circulation of critical paper documents (batch dossier / production protocol)
  • User access management
  • Prevent deleting or modifying data by users (even on secure systems)

As a result, you will have an effectively implemented data integrity policy and will be able to form a Data Integrity culture on your own.

LIST OF WORKS ON DATA INTEGRITY

Analysis
  • Audit of existing documentation
  • Data integrity audit
  • Information security audit
  • Audit for compliance with CFR 21 Part 11
Implementation
  • Data Mapping
  • Development of data integrity policy
  • Personnel training
  • Implementation of data integrity policy