DATA INTEGRITY FOR PHARMA Industry

Importance of DATA INTEGRITY for PHARMA Industry 

Data integrity refers to the accuracy, completeness, and consistency of CGxP data over its entire lifecycle. 

The steps that need to be overseen include the initial generation and recording, the processing (incl. analysis, transformation, or migration), the outcome/use, the retention, retrieval, archive and finally the destruction.

Data integrity means that all the steps defined above are well managed, controlled and documented and therefore the records of the activities follow the ALCOA+ principles described in the guidelines.

The ALCOA+ principles have been in place for several years in the industry and are widely known and implemented.

Achieving data integrity compliance, for paper, electronic and hybrid systems, requires translation of these principles into practical controls in order to assure CGXP-impacting business decisions can be verified and inspected throughout the data lifecycle.

The current guidelines on data integrity require that companies' complete data integrity criticality and risk assessments to ensure that the organizational and technical controls that are put in place are commensurate with the level of risk to quality attributes.

Below the pillars of the Data integrity governance:

Organisational Culture

Organisational culture has the potential to increase the possibility for lapses in data integrity; intentional (e.g., fraud or falsification) or unintentional (e.g. lack of understanding of responsibilities and/or requirements).

Awareness

It is crucial that employees at all levels understand the importance of data integrity and the impact that they can have on CGXP data with the authorisations assigned for their job roles.

Training 

Training is a major component of raising awareness and should be conducted periodically.