Compliance

PRODUCTS

  • PHCbi brand’s LabSVIFT® IoT lab management solution is designed to provide real-time visibility and control of laboratory equipment and environments across single or multiple facilities. This cloud-based platform enables centralized monitoring, customizable alerts, and secure data access via a web-based dashboard. The new health check* function continuously evaluates equipment performance, identifies irregularities, and provides recommended corrective actions to maintain optimal operation. The system supports FDA 21 CFR Part 11 compliance and is compatible with select PHCbi and third-party devices. *health check function compatibility varies by model

  • Capture EHR/EMR data in TrialKit with no integration required.

  • A flexible solution for all your low-pressure and vacuum applications
    Robust ZM oil-free multistage centrifugal blowers and exhausters provide you with the air or gas, pressure or vacuum you need at low maintenance costs.

  • The most widely trusted solution for clinical trial disclosure management

    Managing clinical trial disclosures can be tedious and error-prone, opening the door to noncompliance. TrialScope Disclose provides a better way.

    Our centralized platform automates data entry and reporting for Clinicaltrials.gov, CTIS, and more. This reduces manual effort so you can focus on bringing new treatments to patients, not paperwork.

  • An optimized and effective Contamination Control Strategy (CCS) helps you organization spend less time cleaning and more time manufacturing. Ecolab Life Sciences experts are dedicated to helping you drive the best possible strategy to meet and exceed the GMO Annex 1 CCS requirements.

WHITE PAPERS AND CASE STUDIES

  • Solutions To Global Pharmaceutical Supply Chain Challenges

    The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasing strategic role. There will be a need for greater agility and speed to market.

  • 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)

  • Serialization And Traceability Compliance In Pharma And Med Device

    Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.

  • Fire And Life Safety And Security Industry

    New government regulations and the need to update outdated or non-compliant technology are requiring building owners and facilities managers to think about upgrading their fire alarm, security, and fire suppression systems with the latest technology available.

  • Advancing Compliance And Digital Strategy To Align With Pharma 4.0

    AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.

  • 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.

  • White Paper: The Impact Of The Internet On Compliance Education I sat with astonishment as the compliance officer of a large corporation told me that he had no idea what compliance education was being performed on a day-to-day basis within his organization. He went on to indicate that his company could not produce reliable documented evidence that its employees had in fact, completed federally mandated education
  • Comparative Analysis For Non-IND Sites

    A cancer research organization that facilitates multi-national clinical trials was in the planning and coordination of a Phase III drug trial and wanted to expand the trial to include German sites. Conducted under an IND, the trial was going according to plan until German regulations changed.

     

     

  • 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
  • TAKE Solutions' Team Announces Conatus Pharmaceuticals The Winner In PharmaReady Best Case Study Contest Recently, TAKE Solutions' PharmaReady team announced Conatus Pharmaceuticals the winner in its best case study contest. Of the numerous award submissions, Conatus won by presenting a detailed look into their search for an eSubmissions solution, including their initial criteria, marketplace comparisons and the end results.
  • 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.

NEWS