Data Integrity in GxP-regulated Fields

Data Integrity

The increasing number of data integrity violations is causing a paradigm shift in the GxP-regulated environment. In collaboration with our clients, we develop the optimal strategies for the prevention, detection and monitoring of data integrity violations.

Ensuring data integrity and compliance with US FDA 21 CFR Part 11 and EU-GMP Annex 11 requirements

Data is an essential part of our lives and many things cannot be expressed without it. Whereas data used to be bound primarily in fixed form on paper or other media, in the information age data can be evaluated and combined at will. Manipulations cannot always be detected early enough. The answer to the challenge of ensuring the evidential value of electronic data is data integrity.

Especially in the health care sector, however, correct and trustworthy data create the basis for the effective use of pharmaceuticals and medical devices for the benefit of patients and other affected persons. Quality and reliability are therefore of paramount importance.

If the validation creates confidence to the effect that processes and systems function as intended, the quality of products and their manufacture is verified with data of high integrity.

Ensuring data integrity begins with correct and complete data capture, follows the flow of data through the processes, and ends with proper filing and retention during the legally mandated retention periods. This data lifecycle must already be taken into account in the planning of technical systems, and proof that data integrity has received sufficient attention must be demonstrated in the validation process.

An essential tool here is to analyse the question the risk to data integrity already in the risk assessment and to provide for risk-minimising measures. The verification phases then offer the opportunity to check the implementation of the data lifecycle in its entirety, end-to-end. This also becomes part of the regular system and validation reviews during the operation phase.

Our Data Integrity Service:

  • Strategy and implementation of the risk-based approach to optimize resource requirements
  • Management Training and Consulting
  • Auditing of automated processes and electronic systems
  • Analysis of data flows (end-to-end)
  • Performing ALCOA(+) analyses
  • Support in the interpretation of US FDA 21 CFR Part 11 and EU-GMP Annex 11
  • Prevention, detection and monitoring of data integrity violations
  • Good documentation practice regarding electronic data and computerized systems
  • Validation concepts to ensure data integrity
  • Integration of the data lifecycle into existing concepts
  • Execution of data risk analyses
  • Concepts for data migration and verification
  • Classification metrics and assessment strategies