Compliance

PRODUCTS

  • APEX 500 Rx
    Pharmaceutical Metal Detector

    Meet FDA guidelines for GMP in tablet and capsule production with a secure, failsafe system. Qualification reports are available.

  • MasterControl MES
    Modern MES Software For Drug Manufacturing

    Eliminate errors and accelerate production with MasterControl MES.

    MasterControl Manufacturing Excellence is a modern manufacturing execution system (MES) that has helped hundreds of manufacturers eliminate millions of errors and deliver products to the market 70% faster.

    It’s time to modernize your manufacturing operations – from digital work instructions and production records (EBR/eDHR) to electronic logbooks and equipment tracking – and see how MasterControl Manufacturing Excellence software can help you run faster, leaner, and smarter.

  • GettyImages-1026593952 tablet, data
    Targeted Source Data Verification

    Ergomed’s Risk-Based Clinical Monitoring and Source Data Verification Approach for Data Integrity

    Ergomed ensures the highest data integrity and patient safety standards through our risk-based clinical monitoring and Source Data Verification (SDV) practices. SDV is a critical process in clinical trials that ensures the data collected are accurate, complete, and verifiable against the source documents. We compare data entered into case report forms or electronic data capture systems with the source data to confirm their accuracy and reliability.

  • Germfree - solid core doors
    Solid Core Cleanroom Service Doors For Drug Manufacturing

    Arcoplast solid core service doors offer superior durability and hygiene. Their innovative design and easy-to-clean surface make them the ideal choice for demanding environments.

  • GettyImages-1398569507 regulatory
    From Risk To Readiness: Strategic Regulatory Support

    Eurofins PSS Insourcing Solutions provides biotech, pharmaceutical, and CDMO organizations with embedded regulatory expertise that strengthens compliance, accelerates timelines, and ensures audit readiness—without adding headcount. With over two decades of insourcing experience and a global footprint across 110+ client sites, PSS delivers strategic, on-site support tailored to each client’s regulatory landscape.

WHITE PAPERS AND CASE STUDIES

  • Regulatory Landscape of Drug-Device Combination Products
    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.

     

     

  • 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.
  • Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx
  • GettyImages-675822224 cleanroom, lab
    Biotech Firm Streamlines Maintenance, Calibration & Validation With RAM

    Explore how a U.S. biotech company uses RAM to centralize maintenance, calibration, and validation to improve compliance, efficiency, and visibility across multiple facilities.

  • 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.

  • Improve Electronic Patient Record Handling
    Phoenix Children's Hospital Improves Service And Timely Revenue With Verisma's Release Of Information Technology And Expert Support

    Since the hospital’s founding in 1983, Phoenix Children’s Hospital (PCH) has provided hope, healing, and the best health care for children across Arizona. Over 80 percent of pediatric subspecialists in the metropolitan area and 50 percent of pediatricians in Maricopa County are associated with PCH’s ambulatory and acute care network.

  • osmolality
    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.

  • 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
  • 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.
  • Tickford Engelhard Makes Catalyst Conform w/o Recalibrating An automaker in the Far East had a mature 2-L model that already met the U.S. transitional low-emissions-vehicle (TLEV) standards...
  • Green Communication: A Polycom Commitment To The Planet Polycom high definition telepresence, video, and voice solutions are changing the way organizations communicate. And that's a good thing for our planet. Although we may be geographically distant from our fellow workers, customers, and partners, we no longer have to travel to be effective. Thanks to high definition...
  • 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

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