THE BUSINESS CHALLENGE
Quality data is more than facts and figures – it’s confirmation that patients can trust.
FDA citations related to data integrity have (and will) continue to be on the rise as the amount and scope of data balloons in nearly every aspect of life sciences. As if the threat of regulatory intervention wasn’t enough, data integrity issues can and will also negatively impact any headway you make in controlling quality costs and efficiencies.
We combine decades of regulatory experience and countless data integrity projects to deliver a non-invasive data integrity program with true value and sustainability.
Achieving data integrity relies on a pragmatic strategy that includes your business goals, culture, and continuous development.
- Master Data Governance Strategy
- KPIs and Reporting
Though it lives primarily in the technology landscape, data integrity is often most impacted by the processes and people involved.
- Data Processes, Procedure, and Ownership
- Awareness, Training, and Change Management
- Data Quality, Cleansing, and Retention
Establishing the supporting technology, architecture, and security for your data creates sustainability and ensures long-term success.
- Data Architecture
- Audit, Compliance, and Security
- Systems Integration
What Our Stewards Say
The FDA has clearly made data integrity a top priority and we’ve followed suit. That increased regulatory focus and the exponential increase in data volume means a preemptive commitment to data integrity will propel any life sciences company into a position of greater value.
We have helped global life sciences companies establish scalable data integrity programs that ensure compliance across multiple regulatory bodies and drive demonstrative improvements to operational efficiencies. For more information on how we can help your company, please contact our data integrity expert, Gary Richey.