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  • Inadequate Instrument Qualification and Analytical
    breaches in compliance, but there was a major focus on instrument qualification and method validation associated with analytical instruments.
  • VICTREX (R) PEEK Meets NORSOK M710 Compliance and Continues to Aggressively Test its Polymers in Support of Industry-Leading Test Standards
    ) and also after. rapid decompression events. Standards such as API 6 "Specification for. Wellhead and Christmas Tree Equipment". and the NORSOK M710 "Qualification. of Non-Metallic Sealing Materials and. Manufacturers" propose specific. environments which may be single. or multi-phase and which consist
  • 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
  • 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
  • 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
  • Any Time, Any Place, Any Product: A Roadmap for Successful International Pharmaceutical Plant Construction Projects
    not measured, it s not managed. The only means to ensure that the project is tracking to its budget and schedule targets is to constantly measure and track the results of construction activities. 6. Facility Qualification: If it won t pass, it won t pay off Once a pharmaceutical facility has
  • A Better Approach to Vendor Audits
    the burden and bureaucracy of vendor qualification, and the life sciences industry is finally beginning to address it. An entire session at the recent ISPE annual meeting in San Antonio was devoted to the issue of vendor certification -- for PAT and other products and services. Officials from ISPE

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