UL helps you solve the complexities of maintaining data integrity.
All over the world on all sizes of projects, pharmaceutical, biotechnology, veterinary medicine, medical device and other life sciences companies trust us to help them get the job done.
We’ve assembled a team of the finest talent in the industry to deliver highly responsive, on-demand support to our partners. We blend seamlessly into your organization, providing the advice, solutions, training and tools you’ll need to make certain that your data records meet FDA, MHRA and other regulatory agency requirements.
The regulatory world is constantly changing, but our commitment to our partners has not. It’s the reason UL is renown throughout the world for compliance, safety and quality solutions.
We’ll help protect you from:
- Increased scrutiny on overseas sites and organizations
- Increased number of findings related to data integrity
- Severe penalties, fines, and punitive actions such as product seizure, site closure, and immediate loss of revenue
- A negative impact on brand value due to the public availability of audit findings and 483s
Expensive remedial measures
- Increased FDA scrutiny in the future
We’re the difference between hoping you
have data integrity and knowing it.
All that we do, we do for one reason — to ensure that your business is not vulnerable to penalties that could cause significant damage. We see your data integrity challenge as an opportunity to provide the right solutions so your organization’s big dreams can always keep moving forward.
Through our years of experience and listening to our partners, we’ve built our solutions based upon the following 10 principles:
- Management Commitment – The primary stakeholders must be onboard and involved.
- Awareness and Regulatory Intelligence – To comply with the rules, create an environment where employees can learn about them.
- Governance – Set guidelines and rules for managing data integrity across the entire company.
- Risk Management – Establish risk monitoring plans to avoid major problems.
- Business Systems Design – Build a system that enables easy data flow between the creation and management of cGMP data.
- Change Management – An effective change management system ensures that changes related to data integrity are assessed, planned and implemented with minimal impact on operations and compliance.
- Events/Incidents Management – Identify, report and ensure that data integrity issues are resolved permanently.
- Reporting – Give stakeholders the ability to access and assess key performance indicators to gain insight into potential problem areas and address them proactively.
- Policies and Procedures – Provide your entire team with clear guidelines on how to maintain data integrity and make it part of your culture.
- Continuous Monitoring – Organizations must consistently review the processes, systems and documents to ensure they are compliant with regulations and business requirements.
Scalable solutions to meet your data integrity needs.
Nimble. Flexible. Resourceful. Scalable. Global. We work with our partners on either target-specific solutions or enterprise-wide plans allowing them to find the UL Data Integrity Management Solution that best fits their organization.
A legacy built on focusing on the details.
For more than a century, businesses have trusted UL for integrity, quality, safety and compliance. They trust us to help maintain their data integrity and protect them from regulatory mishaps. And that keeps their businesses moving ever-forward.
To learn how UL can help establish your data integrity through our customizable solutions, call us at 1-877-338-6337 or reach out through the form below.
Outside the US at : +1-609-627-5300