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  • A Compliance and Traceability Toolkit
    The MasterControl integrated quality management suite is a configurable, off-the-shelf, and easy-to-use software solution that facilitates GxP or CGMP compliance from R &D through post-marketing. It integrates different quality processes and connects various departments involved in the compliance
  • A Compliance and Traceability Toolkit
    Software s platform. We asked Tim Fischer, Leiner s director of regulatory compliance, to share some of his team s experiences in implementing the software. His advice, in a nutshell: Leiner s implementation team spent a considerable amount of time working through a User Requirements Document
  • Software Solutions Help Water, Wastwater Operations Hit Moving Environmental Compliance Targets
    Platforms. Software Solutions Help. Water, Wastewater. Operations Hit Moving. Environmental. Compliance Targets. As drinking water standards and effluent discharge regulations get increasingly. stringent, water-centric utilities are optimizing processes and recordkeeping. with industry-specific software
  • Medical Device Link . Software
    . Advertising Information. Upcoming Issue. Editorial Calendar. Home \. Magazines \. European Medical Device Manufacturer. PRODUCT UPDATE Software From product design to the management of regulatory data, increased efficiency and productivity are often dependent on investing in appropriate
  • New Calibration Management Suite Facilitates 21 CFR Part 11 Compliance
    applicable to the pharmaceutical industry and to other FDA-regulated industries. "CMX complies with 21 CFR Part 11 and excels at security, audit trails, electronic signatures and change management control, " says Sami Koskinen, Beamex's software product manager. Among the features that facilitate 21 CFR 11
  • Medical Device Link . Software Risk Management: Not Just for the Big Manufacturers? Risk management is not as complex or expensive as many small device manufacturers may think. In fact, it can actually save money.
    they become either threats to successful operation or major sources of software rework. Regulatory officials recognize the need for such deliberate risk management. For instance, FDA's September, 1996, 510(k) draft guidance contains a section that spe-cifically addresses software risk management
  • Alarm Response Management (.pdf)
    At best, too many alarms can be a nuisance and deter productivity. But uncommon alarms requiring the correct emergency response can be dangerous, and even detrimental to your organization and customers. Alarm Response Management software, which layers easily on top of existing HMI/SCADA systems
  • Thermal Management of UltraVolt HVPSs
    Any electronic device's long-term reliability is directly related to how the overall system design allows it to dissipate any generated heat properly. Likewise, the long life and reliability of UltraVolt high-voltage power supplies (HVPSs) will be enhanced through proper thermal management. High

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