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Data without integrity is just numbers: a risk-based approach to Data Integrity

Data without integrity is just data

Systems compliance strategy  according to Data Integrity and Software Selection in QbD

PTM Consulting developed a methodology to support companies to build appropriate Data Integrity strategies, with a new  approach, integrated to the company Quality System and based on sound risk analysis and management, according to the principles of the Q9.

Systematic and versatile, the methodology  can be used during the design phase of a  Data Management  process as well as  during the  analysis  and reengineering  of existing processes.

In particular, two highlights :

  • Systems compliance strategy according to Data Integrity;
  • Software Selection according to Quality by Design.

Two are the common keypoints of these services:

  1. Knowledge of the process, an essential starting point to set up the process activities, as well as the project activities,  through Cymapp, the proprietary system developed by PTM for functional and data mappings;
  2. Evaluating the Intended Use of the Data  to define  your process criticities.

For more information on the Data Integrity service, contact Giorgio Kyriacatis, COO and Business Development Manager at

Download data without integrity is just numbers