The U.S. Food and Drug Administration (FDA), among other global agencies, has recognized the importance of data integrity and the quality and compliance risk a lack of data integrity can cause.
UL’s Data Integrity Program within the ComplianceWire® Learning Management System (LMS) helps companies identify and correct issues and build sustaining programs to reduce future risk of data integrity findings. UL’s Data Integrity program includes a network of knowledgeable professionals to assess companies’ current data integrity practices, identify risks and make sustainable improvements.
ComplianceWire® is the best-in-class web-based platform designed specifically for highly regulated industries. It is designed to automate the creation, delivery and reporting of your role-based training, qualification and compliance programs effectively and efficiently. ComplianceWire® was built from the ground up to be fully compliant with 21 CFR Part 11 and EU Annex 11 validation requirements. This time-tested technology is used extensively by U.S. and global pharmaceutical, medical device and biologics companies as well as global regulatory authorities in the U.S., China and India.
UL’s Data Integrity Program will help ensure your data is accurate, complete and reliable. The process begins with a virtual or on-site orientation through your organization followed by interviews with key leaders and stakeholders within the organization to better understand data integrity gaps. Once gaps/risks related to data integrity are identified, UL works closely with your team to support the recommended issue resolution.
Elements of the program
Orientation and awareness
The Data Integrity program begins with a virtual or on-site orientation through your organization, focused on core areas of GxP environments, such as QC labs, batch record production and IT. During this initial education, we share best practices in regards to regulatory expectations, using technology and supporting a culture that minimizes risk of data integrity findings.
Data integrity gaps and risk assessment
Our team assesses organization policies, procedures and practices against regulatory guidance for data integrity and industry best practices. Our team also conducts audits to identify high-risk areas, functions and facilities. We review our findings and observations with key stakeholders to establish a plan of action to address and resolve gaps and risks.
After identifying gaps and risks associated with data integrity, we work with your team to make recommendations and support issue resolution. We may also follow up with a second audit of high-risk areas to confirm that recommended changes were made and best practices and procedures for high-quality data integrity are in place.