Assuring Data Integrity towards Regulatory Compliance: A Study on Process Improvement in Data Integrity Compliance of Computerized Systems

Abstract

The objective of this thesis is to review and revise the verification process for data integrity compliance of computerized systems used in the case company to a more streamlined, efficient and risk-based approach. Data integrity compliance is a subset discipline supporting the GxP-relevant processes to assure the manufacturing of products — its quality, purity, and efficacy, and to eventually warrant the safety of the patients. Decisions are made based on relying on critical data and records therefore data, in its essence, is fundamental to be proven as credible and truthful. As digitalization increased in the pharmaceutical and life science industry, the need for data integrity controls inclusion also increased in configurations, requirements, and specifications. This study used applied action research as its research approach and relied on qualitative research methods in order to improve the verification process of the case company to a more streamlined, efficient, and risk-based approach.

Currently, the data integrity compliance process at the case company is already defined but may have the tendency to mislead the risk assessment when systems complexity is not accounted for, or difficulties in implementation due to ambiguities and missing acceptance criteria. Therefore, the current state analysis determined the focus areas for improvement based on the risks assessed at a system level down to the system functions such as its impact on product recall and lot traceability, regulatory records to be submitted, aiding the manufacturing process, and product labeling, etc. With this, an understanding of the current data integrity maturity level was a starting point for the proposed improvements.

The outcome of this thesis is a proposal on how to strengthen the verification process of data integrity compliance without compromising the quality. The data integrity compliance improvement proposal was formulated collaboratively with the participants, validated, and implemented with additional training throughout the organization to raise awareness of the significant role of each one in the culture and overall compliance to data integrity. There will always be an area for improvement particularly on this topic when more and more complex technologies will be introduced in the future.