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How To Design, Select and Implement Application Software To Ensure Data Integrity in GXP Regulated Laboratories

Data integrity continues to be a major problem in GXP regulated laboratories often giving Health Authorities reason to doubt data generated. Following untitled letters sent to Panexcel and Synchron Research Services last year, sponsors have to repeat all bioequivalence studies analysed by these two contract research organisations as the data cannot be trusted. Therefore, the presentation will cover the following topics to describe how to use application software to ensure data integrity:

  1. Process understanding is critical: map and simplify the process to be automated
  2. Audit trail requirements and potential problems for system selection and operational use
  3. Selecting the right system for the job
  4. User Roles and Access Privileges
  5. Prototype the process with configured software and refining if required

Attend this webinar to learn:

  • How to design, select and implement application software to ensure data integrity in GXP regulated Laboratories
  • How to avoid conflicts of interest when defining user roles and access privileges
  • How to write intended use requirements to enable system selection
Bob McDowall
Bob McDowall
Director, R D McDowall Limited