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  • Inadequate Instrument Qualification and Analytical
    for various. breaches in compliance, but there was a major focus. on instrument qualification and method validation. associated with analytical instruments.
  • Determine System EMI Characteristics Early in System Design Phase
    Often in the commercial, industrial, medical and military industries, system engineers wait until system qualification before addressing critical functions for EMC and EMI compliance to relevant standards. The most common mistake is the belief that a power supply with EMI compliance certifications
  • Medical Device Link .
    not only on the actual manufacturing techniques, but also on the manufacturing environment, cleanrooms and the related ventilation facilities must be qualified. Qualification entails checking cleanroom facilities for compliance with the relevant technical rules and regulations, and evaluating
  • The Hidden Value of Instrument Manufacturers
    For those of you who work with any analytical/lab or process instruments, you know that staying in compliance with global regulations has become burdensome in the past decade. Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments
  • The Water Factor in Medical Device Resins
    are scrutinized. more thoroughly than other resins that require less regulatory compliance. Analyzing a product for. outgassing, deformation, and reactivity, among other things, has become part of the daily routine for. manufacturers, molders, and final inspection personnel before an item can be shipped
  • Risky Business
    Risk-based compliance should also allow manufacturers to re-examine older, more holistic validation approaches, rather than fixating on individual components. "That's how it was done before computer system validation became big in the 1990s, " Kovacs says. Before computing emerged as a separate
  • Any Time, Any Place, Any Product: A Roadmap for Successful International Pharmaceutical Plant Construction Projects
    at the end. Some of the more challenging aspects of commissioning and validating an international project include finding qualified staff, determining start-up consumables and spare parts, and ensuring compliance with international regulations. A compliance master plan defines the guidelines to be met
  • Medical Device Link .
    New EMC Requirements with the Updated Medical Devices Directive The deadline for compliance with new test standards to qualify equipment for sale in the European Union is November 1, 2004. The European Union (EU) requirements for selling and marketing electrical and electronic medical devices
  • Medical Device Link .
    manufacturers are increasingly incorporating validation software and equipment into their machines. Rod Jennings of Van der Stahl Scientific Inc. says that his company's new pouch sealer "will incorporate real-time seal-integrity monitoring to enhance validation compliance. " Enhancements to validation

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