Compliance

PRODUCTS

  • Discover how a team of biostatistics and pharmacokinetics experts can offer specialized guidance for clinical trial design and analysis.

  • Polyzen is an innovative leader in the manufacturing and processing of components for a wide range of medical devices and is a preferred supplier to medical device OEMs worldwide. Extensive in-house processing capabilities and process technology experts enable us to manufacture an array of plastic components. These include medical grade polymer films and laminates, lay-flat tubing, balloons, bags, sleeves, stent and catheter coatings, and much more.

  • Did you define your manufacturing contamination control strategy, or is it a collection of changes over time?

  • When it comes to your fill-finish workflow, sterility and efficiency are key. Denest and renest with confidence! Our ready-to-use (RTU) denesting equipment is here to help you separate and reassemble your products with ease. Rest assured the Hull i-Dositecno Denesting Equipment is robust and efficient, so your sterile, clean, ready to fill (SCF) components are transported smoothly through your fill-finish workflow.

  • The MM1-1886HCSP2 is a highly linear passive GaAs double balanced MMIC mixer suitable for both up and down-conversion applications.

WHITE PAPERS AND CASE STUDIES

  • The Importance Of Quality In Raw Material Selection

    Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization. 

  • Focus On Your Core Business Strategy

    Learn how a large manufacturing client helped to focus on their core business with a solution that transitioned approximately 60% of the workforce and capitalized on the initial training investment.

  • Commercial Metals Company Centralizes AP Processes And Save 55,000 A Year With ImageSilo® When the Director of Shared Services at Commercial Metals Company (CMC) was asked to centralize the accounts payable processes of 40 metal recycling yards scattered across the country, he quickly realized that paper documents were the roots of his AP problems at the yards. By Digitech Systems, Inc.
  • 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?

  • Ensuring Compliance With Part 11: A Site's Perspective

    As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.

  • TEDS Releases Compliance And Competencies Case Study On Dominion Resources. By Bersin & Associates' Chris Howard, Principal Analyst. TEDS, originator of the only fully integrated enterprise-wide talent management solution, recently released a case study highlighting the strength of its powerful LMS, Learning on Demand and TEDS RTC Power, a highly robust compliance and competency management tool
  • Security In The Supply Chain

    When analyzing a transportation company regarding its capabilities to keep cargo safe from theft, there are a variety of questions that a decision-maker should ask in an effort to effectively measure the security skills of the carrier.By FedEx Custom Critical

  • 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.
  • Secure Storage: A Necessary Evolution All large organizations have gone to great lengths to protect their information assets. All kinds of security systems, from network firewalls and VPNs to passwords and physical mechanisms have been implemented to prevent unauthorized access to networks and premises. Submitted by Nexsan Technologies, Inc.
  • Malware Creativity Means VAR Opportunities To highlight the market opportunities for VARs, PC Tools released the findings from a worldwide survey of more than 25,000 respondents — of which 12,307 were from the United States. By Business Solutions magazine
  • Software Automation In The Blood And Biologics Industry

    Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.

  • White Paper: The 5 Pitfalls Of Implementing Project And Workflow Management Software The benefits of implementing an end-to-end project and workflow management system may seem like a panacea to executives and senior managers. Operational efficiencies and increased collaboration among employees may result, along with improved compliance and a comprehensive real-time view of operations for rapid executive decision making.

NEWS