Data Integrity Services

Data Integrity Services for the Life Science Sector

Build a strong program foundation with reliable data integrity support

Data Integrity (DI) is a key factor for ensuring patient protection and an enabler of every Quality Management System (QMS) in the life science industry. Without proper life science data integrity processes in place, pharmaceutical and other companies create a recipe for disaster.

DI failures put patients’ health at risk. Lapses and fraud can lead to product quality issues and have the potential to cause drug shortages. Regulatory actions like the FDA’s 483 observations and warning letters can evaporate trust into companies. 

Sound DI is the critical foundation upon which every life science company is built—and GxP-CC is the consultant life science companies trust to support compliance in every element of their DI programs.

Data overwhelm drives DI program failures

Life science data integrity programs can be burdensome, bind resources, and shift focus away from quality surveillance to mindless “checklist compliance.” In some instances, assessments can become so extensive that companies and their data management teams become overwhelmed by data that lacks direction, leading DI programs to suffer from an all-too-common “death by assessment.” With this heavy-handed focus on securing more data, DI program managers tend to forget the importance of critical soft factors, like building a quality culture that ensures your team’s mindset prioritizes quality.

Typical remediation programs may include holistic technical solutions for data centralization and advanced technologies—solutions that require separately administered and financed projects. To avoid the added cost, many organizations opt for burdensome paper-based mitigation strategies instead.