Compliance

WHITE PAPERS AND CASE STUDIES

• ARMA 2005 Show Highlights Refined Solutions For Records Managers The message to attendees of this year's ARMA show was to engineer an easy transition from paper-based files to electronic records management, supported with a clear and calculated plan. ARMA provided me a chance to sit down and talk with ECM vendors about the special offerings they had for solving companies' records management needs. Check out some of news and highlights from the manufacturers and software providers that were at the show.
• Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors

  Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.

• Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines

  As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

• Osmolality: A Powerful Tool In Bioprocessing

  Learn more about the broad range of applications for osmolality testing and why it is crucial for process development, analytical development, and GMP testing.

• PCI Compliance: Keep Your Customers And Business Secure The PCI DSS provides steps to protect organizations, customers, and the card processing system from fraud. The steps include requirements for security management, payment policies, data storage procedures, network architecture, software design, and other payment system measures. Submitted by Heartland
• Continuous Flow — An Emerging Alternative

  Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.

• Delivering Apheresis Treatment From The USA To The UK Within 24 Hours

  The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.

• Have Confidence In Your Bio/Pharma Data

  The pharmaceutical industry has grown from simple aspirins to IV delivery, antibiotics and, most recently, cell and gene therapy. Products are more complex, tailored and varied than ever and the associated amount of data is growing - which requires a new level of attention to detail. Learn what features tolook for when choosing a data management system to establish compliant data visibility across teams, sites and partners and establish data integrity throughout the product life cycle.

• 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
• 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.

• Leveraging AI For TMF Classification To Improve Quality, Consistency

  Explore diverse AI methodologies, such as natural language processing and machine learning, elucidating how they seamlessly integrate with current systems to elevate efficiency and uphold quality standards.

• 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...