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.
- How GxP-CC Can Help
Trust GxP-CC to help you create a life science data integrity program that is more purposeful and less burdensome. We have years of hands-on experience in rolling out reliable data integrity programs. Our DI experts lead and support data integrity initiatives for international groups, publications, and industry-leading conferences such as those held by the Parenteral Drug Association.
- Our Offerings
GxP-CC provides data integrity services for each phase of the product life cycle, from Good Clinical Practices in research phases through Good Manufacturing Practices that support compliance in production. Our life science data integrity services include:
- Data integrity workshops customized to your organization’s needs, with hands-on examples and informative case studies
- Data integrity assessments, including framework and process assessments
- Data integrity remediation programs
- Data integrity GEMBA walks
- Data integrity audits and audit preparation
Drive your data integrity program beyond simply serving compliance needs. Together, let’s ensure your data is your most valuable asset. ICH guideline Q9 Quality Risk Management (R1) emphasizes this very need by pointing out the importance of data-driven knowledge. This is an area where compliance needs meet business advantages.
Schedule a call now to learn more about how our life science data integrity services can support your compliance needs and enable data-driven innovation.