Compliance

PRODUCTS

  • If you need robust and reliable fill-finish equipment that causes minimal disruption to your existing footprint, the Hull i-Dositecno LI Versa-Line™ Pharmaceutical Filling equipment is here to help! Accessibility from one side means you can install at the wall for a linear filling and capping system that fits neatly into any space.

  • Enable co-location of cell culture media and buffer manufacturing and bioproduction with Krakatoa K500, the first bioreactor-scale pod-based manufacturing system. Produce up to 500 liters of sterile solutions on-demand in less than 3 hours.

  • Obtain die-level balun performance in a compact surface mount package using Marki Microwave’s CSP2 chip scale package technology.

  • Gain expert guidance and connect with a global network of qualified QPPVs and LPPVs, who will ensure compliance with pharmacovigilance regulations and tailor their approach to your product launch strategy.

  • Eurofins PSS Insourcing Solutions delivers comprehensive manufacturing support that meets production goals with precision, compliance, and agility for biotech, pharmaceutical, and CDMO organizations. Our insourcing model places fully trained, managed scientific teams directly at client sites, enabling seamless integration into manufacturing operations while maintaining flexibility and long-term stability.

WHITE PAPERS AND CASE STUDIES

  • Validation Provider Shortens The Path To Equipment Qualification

    Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

  • Improving Global Labeling Workflow

    One of the leading suppliers of medical devices to the orthopedic market has been working with label lifecycle management solution provider, PRISYM ID to help implement a compliant label solution with validated label processes for its product portfolio. The company manufactures and delivers products with a wide range of capabilities including joint replacements, spine and micro implant systems, orthobiologics, powered surgical instruments, surgical navigation systems, endoscopic products as well as patient handling and emergency medical equipment. After looking at the company’s requirements, PRISYM ID implemented a solution to ensure regulatory compliance and the automation of the labeling functions.

  • 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
  • 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.
  • GFI Case Study: GFI MailEssentials & GFI MailArchiver Machine Solutions Inc. an Arizona-based manufacturer of medical product testing equipment, was faced with two email-related issues: first, the ever-increasing volume of spam that was reaching the company and second, the problems associated with cumbersome .pst files and the lack of a real-time archiving system.
  • 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.

  • Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

    The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

  • 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.

  • Developing An Organizational Roadmap For Post Authorization Safety Studies

    Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.

  • California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
  • Making Money With Security Awareness Training

    How addressing human error reduces risk and bolsters your profitability.

  • Strategic Hiring For Scalable Success

    Discover how a people-first talent strategy, purpose-driven culture, and cross-functional collaboration come together to support scalable growth and operational excellence in commercial manufacturing.

NEWS