Compliance

PRODUCTS

  • Take control of your production by tracking every part, assembly, and batch with precision.

  • Access, interact with, and even adjudicate clinical trial imaging from the same platform where you manage all other study data.

  • 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.

  • Ensuring you have equipment that accurately and rapidly assembles syringes and cartridges is crucial to the success of your pharmaceutical manufacturing workflow. The Hull i-Dositecno SY pharmaceutical labeling machine harnesses dual-function robotics for plunger insertion and labeling to ensure the safety and sterility of your product.

    • Versatile – ideal for syringes or cartridges in sterile, clean, ready-to-fill (SCF) tubs
    • Cleanroom ready
    • Fully compliant – 21 CFR Part 11 software and IQ/OQ validation packages available
  • For your efficient and error-proof production: Our world-leading Manufacturing Execution System (MES) Suite PAS-X controls, monitors, and documents your processes digitally and in real time throughout the entire manufacturing cycle.

WHITE PAPERS AND CASE STUDIES

  • Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

    Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

  • Why Compliance-Driven CDMOs Win Sponsor Contracts

    Learn how digital maturity and compliance excellence are reshaping CDMO competitiveness, as well as strategies that strengthen performance and accelerate tech transfers.

  • Graniterock Speeds Up Reporting From 7 Days To Real Time

    Graniterock is one of California's premier construction materials producer, delivering hot mix asphalt, recycled asphalt, concrete and other materials to roads, highways, runways and bridges from San Francisco to Monterey. Safety is a core value at Graniterock, and the company requires employees to adhere to safe work practices at all times. The company wanted to update its slow, paper-based process for equipment and safety inspections to a more efficient solution based on mobile devices and cloud-connected services.

  • Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

    Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

  • Physicians Medical Group Cuts Processing Time With Datacap Taskmaster Physicians Medical Group of Santa Cruz County (PMG) cut its claims processing time by more than half and provided faster access to data, fewer compliance concerns, happier employees and more satisfied customers with an integrated solution from Datacap and Bowe Bell & Howell. Submitted by Datacap
  • GFI Case Study: Montclair Board of Education Montclair Public School District, is recognized by the United States Department of Education as one of the six best magnet school districts in the country with a group of schools falling under this umbrella name that accept students ranging from ages 5–16. Over 2,000 employees using email extensively and with...
  • 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
  • Making Money With Security Awareness Training

    How addressing human error reduces risk and bolsters your profitability.

  • Security PCI Compliance Overview Payment Card Industry (PCI) Compliance is a set of security standards that were created by the major credit card companies (American Express, Discover Financial Services, JCB, MasterCard Worldwide, and Visa International) to protect their customers from increasing identity theft and security breaches. Submitted by Agilence
  • Case Study: Excavating Company Gains Environmental Compliance For Vehicle Wash Water Brownsville, Penn.-based, Brubacher Excavating, Inc. performs a full range of excavating, pipe and utility installation, roadway construction, general earth moving activities and related site development services in Southeastern Penn. Although the company washes its heavy equipment regularly, its dump trucks and tractors account for the most frequent use of its wash bay.
  • Aligning Competing Interests While Optimizing The Service Chain In The Transportation Sector

    This paper explores convergence in detail, starting with a breakdown of the service chain into its key components. We then discuss the obstacles and inherent consequences of inadequate efforts in each of these areas before presenting a model that helps set transportation companies up for success in service chain optimization.

  • 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

NEWS