Compliance

WHITE PAPERS AND CASE STUDIES

• Can Your Biopharma Team Keep Unplanned Downtime At Bay?

  Learn how teams reduce downtime, strengthen compliance, and respond quickly to equipment issues through proactive maintenance, smart spare parts planning, and digital troubleshooting tools.

• Managing Hospitality And Entertainment Spending The ability for hospitality and entertainment enterprises to effectively source, procure, and manage their spend must keep pace with the demand for promptness and compliance in supplier relationship management (SRM). Submitted by Epicor Software Corporation
• Remote ECG Solution Enables A Fully Decentralized ME/CFS Phase 2 Trial

  Explore the transformative potential of digital health tools in addressing longstanding accessibility challenges in ME/CFS research and beyond.

• Client Story: Efficiency Enabling CSV At Scale

  Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.

• Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements

  A large multi-national pharmaceutical company needed assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products. The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area – and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence - into compliance with PLL. Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.

• Tickford Engelhard Makes Catalyst Conform w/o Recalibrating An automaker in the Far East had a mature 2-L model that already met the U.S. transitional low-emissions-vehicle (TLEV) standards...
• Operationalizing Disclosure Intelligence For Go-To-Market Success

  Regulatory intelligence goes beyond ensuring compliance. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start, and position themselves as industry leaders.

• Connected. Intelligent. Compliant. The Next Leap In Pharma Manufacturing

  Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.

• TEDS Releases Compliance And Competencies Case Study On Dominion Resources. By Bersin & Associates' Chris Howard, Principal Analyst. TEDS, originator of the only fully integrated enterprise-wide talent management solution, recently released a case study highlighting the strength of its powerful LMS, Learning on Demand and TEDS RTC Power, a highly robust compliance and competency management tool
• DeKalb Medical Center Secures Patient Data With Proofpoint As a medical center, DeKalb Medical Center is very sensitive about patient privacy. Recently, the organization conducted an audit of its data security and determined that outbound email was a high-risk area for protected health information (PHI) to leave the enterprise. As a first step, the medical center needed to secure its outbound email stream to ensure that PHI was not being sent out unencrypted. By Proofpoint
• Virtual Study Yields High Compliance & Retention Rates

  Clinical research studies involving repeated patient reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Read how an app was used in a study that enrolled 124 patients resulted in the majority of participants in the study being 100% compliant and retained through study end.

• Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System When Peter J. Mueller, Manager of Global Quality Information Systems selected a global CAPA (Corrective and Preventive Action) system for his company, he knew exactly what he was looking for...