White Papers
Helping you achieve your goals through documented industry experiences
2017 ComplianceWire Benchmarking Study
In this report, UL Compliance to Performance presents the results of our annual Compliance to Performance Learning Trends’ benchmarking survey, as well as critical knowledge projects with more than 400 Life Sciences companies in 2016.
Qualifying Clinical Site Personnel Using Embedded Automation
The prospect of an FDA inspection doesn't need to be scary with proper awareness and practical compliance. This white paper explores the rising number of inspections as well as the facilities most likely to face an inspection in the future.
Quality Risk Management Workshop Summary
This paper summarizes critical presentations from UL’s Risk Management workshops, held in Hyderabad and Mumbai in March 2017. Through these presentations, attendees learned how silos threaten quality culture, and how both a formal risk-based approach and the Total Quality Management method can improve culture.
Five Learning Management Elements for Emerging Companies
Many of UL's clients have made the difficult transition from the commercialization stage to large-scale production by investing in a sustainable learning & development infrastructure. This eBook describes five elements that are typically part of a successful learning and management strategy.
A Model for Training/Qualification Record Validation within the Talent Management System
This paper presents a model for FDA-regulated companies to validate the LMS component of a talent management system, including performance management, goal setting and competency management tools.
A New Approach to Quality and Compliance eLearning
New technology can add a significant boost to companies' training programs by allowing an affordable and always on option to learners. This white paper discusses how to take back the learning process with customizable solutions.
Seven Data Integrity Validation Documents and Records Every Life Sciences Executive Needs to Know
Data integrity is one of the most relevant topics in quality management today. This white paper discusses practical considerations and solutions to managing regulatory risk and achieving a sustainable data advantage.
A Tale of Two Cs - From Compliance to Competency
Compliance-centric organizations tend to focus on meeting minimum requirements. Learn how taking a competency-first approach can build a flexible, highly skilled and technically adept workforce.
Beyond Compliance: Competency and Performance
See how top Life Sciences companies use roadmaps to achieve compliance as a by-product of competency while reducing waste and increasing employee performance and retention in the process.
Blended Learning for Organizational Competitiveness
Instructor-led training, on-the-job training and eLearning each has their pros and cons. See how a blended learning approach formulated for the needs of your organization is the best solution.
2016 ComplianceWire Benchmarking Study
In this report, UL presents the results of our annual “Quality and Compliance Learning Trends” survey, as well as critical knowledge projects with more than 400 Life Sciences companies in 2015.
Blueprint for Optimizing Supply Chain Control Within the Life Science Industry
This paper discusses three elements that Medical Device manufacturers include in their supply chain operations to optimize control: supplier oversight, analysis and collaboration.
Compliance Training Cost Efficiencies of Off-the-Shelf eLearning White Paper
While the convenience of purchasing compliance-centered eLearning courses is obvious, many companies are questioning their financial value. This white paper explores the cost effectiveness of "ready-made" programs relative to those developed in-house.
How to Ready Your Organization for an FDA Inspection
The prospect of an FDA inspection doesn't need to be scary with proper awareness and practical compliance. This white paper explores the rising number of inspections as well as the facilities most likely to face an inspection in the future.
IEC 60601 Amendment 1 and Risk Management
Risks to the performance of a medical device can exist at any point in the product lifecycle. This paper discusses the role of risk management within 60601 Amendment 1.
Life Science Best Practices: Moving Beyond Compliance
Learn best practices in compliance training rollout from B.Braun as they go beyond FDA and ISO compliance in a way that benefits their employees, their company and ultimately their patients.
Technology’s Role in Improving SOP Management Processes
Companies need to demonstrate full control over GxP document and training management programs. This paper discusses how cloud-based DMS to LMS integrations can simplify the governance model.
The Current State of Compliance Learning Within Plan Sponsors
Read the results and observations from UL’s survey on compliance learning trends within integrated care organizations.
The Emerging HR Imperative: Five Insights for Bridging the Training Effectiveness and Talent Management Gap
Human resources is helping lead the transition from compliance to competency. See how companies can improve technical skills and competency training, drive business performance and retain top talent.
Top Seven Risks to Consider When Selecting a Life Science LMS
This paper provides seven critical risk areas that QA and IT Validation teams should examine when evaluating an enterprise learning management system for the Life Sciences.
Preparing for an Audit
The FDA has recently increased inspection of foreign pharmaceutical and medical device facilities. Avoid Warning Letters and product bans by properly preparing for inspection.
US FDA Compliance in China and India: How to Prepare for a GMP Inspection
The FDA has recently increased inspection of foreign pharmaceutical and medical device facilities. Avoid Warning Letters and product bans by properly preparing for inspection.