Compliance

PRODUCTS

  • Single-Use System

    The U2k® single-use centrifuge is the scaled-up version of our successful UniFuge Pilot product. It uses gamma-irradiated, single-use modules to eliminate cleaning needs. It is designed for primary clarification of mammalian cell cultures (e.g., CHO cells) and harvesting (including washing and concentrating) stem cells and other types of cells for biotechnology and pharmaceutical applications.

    • Bowl capacity: up to 9 L
    • Flow rate up to 20L/min (5 times the flow rate of the UniFuge®.
    • Small footprint: 80 cm x 206 cm x 200 cm high (31” x 81” x 78”)
    • Easily movable with stainless steel casters leveling on skid with vibration isolators
    • Gamma-irradiated single-use modules
    • Scale processes down with the UniFuge® Pilot and UFMini®
  • Pharma 4.0 is transforming the way life science teams work, interact with their environments, share data and execute processes with the end goal of increasing speed to market. The internet brought us to Industry 3.0, while Industry 4.0 introduces the idea of converging people, systems and data within one network.

  • Discover Germfree’s custom modular radiopharmaceutical manufacturing or compounding cleanroom facility, expertly designed to accommodate a wide range of manufacturing and compounding requirements. This customizable solution caters to the long term capacity needs of radiopharmacies, individual hospitals or entire systems, providing the flexibility and efficiency necessary for today’s demanding healthcare environments.

  • Maximize productivity while meeting regulatory requirements.

    Finally, an ISO 17025 accredited service for automated liquid handlers–so your team can stay focused on what they do best.

  • Zelta’s EDC has been used in more than 4,000 studies from startup to submission, across all phases, including over 500 phase 3c trials and 23 therapeutic areas.

WHITE PAPERS AND CASE STUDIES

  • Case Study: Financial Services Firm Remains Compliant With ProStor InfiniVault® Selero provides highly automated trade execution and connectivity solutions for the equities trading marketplace. The company’s solutions are designed to be fast-to-implement, fast-to-operate, and fast-to-adjust in response to real-time market dynamics. Selero’s customers include asset managers, broker dealers, exchanges, electronic communications networks, automatic transfer services, and regulators. By ProStor
  • Warehouse Management Technology And 21 CFR Part 11 The FDA does not formally review, approve or disapprove products or services that enable organizations to comply with FDA regulations. Although systems such as warehouse management applications can not be certified, they definitely play an important role in a companies ability to achieve compliance. Submitted by Irista
  • Support Manufacturing Operations With Process Data Management Software

    Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).

  • The Dog Ate My E-Mail: SOX For The Midsized Enterprise On July 30, 2002, the act of Congress known as Sarbanes-Oxley (SOX) was enacted into law. Since then, boards of directors of midsized enterprises have been scrambling to comply with the act. So how is the midsized enterprise supposed to "keep up" and stay compliant? This white paper will cast some light on the fears of managers and examine several points on SOX compliance that are feasible for the midsized enterprise. Submitted by Xiotech
  • Nemours Children’s Health System Enhances Patient Experience With HID Global EPCS Solution

    HID Global Solution Enables DEA-compliant Electronic Prescriptions of Controlled Substances (EPCS)

  • Implementing A Compliant Electronic Health Record Information Infrastructure In the late 1990s, the Institute of Medicine’s (IOM’s) study, “Computer-based Patient Record Systems—The Essential Technology for Health Care," depicted a computer-based, longitudinal, lifelong, integrated patient record that included entries from all healthcare providers. By EMC Corporation
  • White Paper: Meeting Compliance Requirements With Document Management Software Compliance is of primary concern to financial service, healthcare, and government organizations. Meeting compliance regulations have historically been perceived as an onerous burden. Today, leading companies are taking a broader approach to meeting compliance and are even embracing the benefits compliance offers. Meeting compliance must be a systemic process that touches all aspects of an organization. Most governmental regulations deal with the handling of business and personal information. Regulations are designed to protect against a diverse array of risks that span different industries, disciplines, and government agencies. By James True, Cabinet NG, Inc.
  • Encapsulon® Assessment Transforms Grocer’s Audit Process

    This case study from Wren Solutions discusses the challenges that grocers face including shrink reduction, employee theft, and shoplifting along with managing complex food safety requirements across multiple sections of their stores.

  • Global Survey On Social Media Risks The use of social media in the workplace is growing at a rapid pace. Savvy businesses are using blogs, social networks, video on demand (VoD), wikis and other vehicles to quickly share information with their target audiences. The result can be greater brand awareness and an enhanced image in the marketplace.
  • A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program

    Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.

  • Case Study: Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
  • Exceeding GMP Of Medical Devices At Each Step In The Production Continuum

    Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.

NEWS