Data Integrity Solution
Global regulators, including US FDA and MHRA, have seen an increase of data integrity issues within the GxP environment.
Regulatory audit observations have included falsifying records, to capturing data in an unreliable manner, no name a few.
It's clear that global agencies expect companies to have implemented risk-based strategies and processes to prevent and detect data integrity issues.
UL partners with companies to assess their current data integrity practices, identify risks and build better processes around data integrity. Our solutions focus on procedures, systems governance, audits, system validation documents, competencies and much more. Companies don't need a band-aid approach to fixing data integrity,which is why our solutions deliver long-term and sustainable improvements:
- UL experts will review your current data integrity processes from a risk-based approach across QC Labs, Batch Record Production, Information Technology, and more.
- UL provides either onsite and/or online educational programs, as well as audits that prepare the GxP workforce for regulatory inspections
- Our experts will do more than simply discuss any data integrity observations uncovered in our audits - we will also work alongside your team to embed process improvements that minimize data integrity issues moving forward, such as systems governance documents, IT validation activities, ongoing competency programs, and more
- We measure the quality culture transformation that elevates the issues of data integrity across the organization, and reduces the risks of data integrity observations in future audits.
The program includes five eLearning courses covering many enforcement issues related to Data Intgreity, targeted to professionals within QA, QC Lab and Clinical. Clients and also receive expertise and process improvements directly from our experts, who can visit facilities and demonstrate how to improve quality culture and embed data integrity into eveyday activities and procedures.