​NNIT is leading the workshop 'Hands-on experience on Data Integrity and Validation of Computer systems' hosted by Atrium. The workshop puts focus on how you can comply with the requirements for electronic systems in GxP, and how to implement valid IT systems.

The one-day workshop gives a hands-on insight into GxP data integrity that is to ensure that data generated by computerized systems is complete, consistent and accurate. It will go through the regulators’ requirements and discuss how those requirements can be implemented in computerized systems.

Mogens Høgsbro Østergaard, Senior Quality Specialist at NNIT and Doli Tyagi, Senior Consultant at NNIT are course leaders and will take the participants through the following agenda:

• GOOD DOCUMENTATION PRACTICE: WHAT AND HOW TO DO IN PRACTICE

• Review of ALCOA+ and how to interpret principles for computerized systems

• Examples of warning letters with reference to ALCOA

• RISK BASED APPROACH

• Impact assessment for IT systems

• Risk assessment for data integrity

• Risk assessment for data and audit trail review

• Data lifecycle mapping, with examples from the real systems and how to identify different types of data

• Risk assessment and IT validation

• DATA GOVERNANCE:

• Data management tools

• Roles and responsibilities

• Companies culture

• CRITICAL THINKING & DATA INTEGRITY

• Data integrity problems and issues detection

• Critical Thinking & Risk based approach
  

To read more about the workshop and sign up, click here