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  • Automotive Oxygen Sensor Dynamic Production Audit (.pdf)
    Testing a device, such as automotive oxygen sensors, that immediately changes resistance when power is applied is exceptionally di_cult. Testing demands precision and advanced waveform analysis techniques to ensure accurate and repeatable results
  • Take Another Look
    is. overlooked. They are process monitoring. and measurement (8.2.3) and internal audit. (8.2.2). An audit can be defined as a comparison. of things as they are to an objective standard. of what they should be. As such, audit. performance-or process compliance-is. the degree to which actual practice matches
  • New Patterns for Quality
    building and environmental monitoring and control systems (that can impact product outcome) that feed into its historian product. Electronic Recording of Batch Records: Once you have a data historian, you ll need a detailed audit trail of the production steps. This record should include material
  • Asset optimization
    affect the productivity, and also resolution of the issues. The optimization audit performed on two new high-speed Newsprint and Writing paper machines in Asia, resulted in enormous benefits in terms of quality and productivity and savings. The optimization audit identifies the bottleneck
  • Inside USP s New Pharmaceutical Ingredient Verification Program
    or certificate of analysis claims for identification, strength, purity and quality. At least three lots will be tested looking for quality consistency from batch to batch. Recertification is required every three years. In the intervening years, a document review, self audit and lab testing on selected lots
  • Products & Services
    of compliance, including automated audit trails, electronic signatures and data security. Procedural elements include Part 11 gap analysis, compliance remediation and ongoing consultation. To address long-term needs, the company also provides a compliance team to oversee ongoing developments, and to guide
  • Tablet Press Makers Take Steps to Ease Changeover, Tighten Performance
    hour. Special seals between the processing and mechanical areas facilitate rapid size changeover. Tablet Press Features Facilitate 21 CFR Part 11 Compliance Control system for the new XL800 double-sided tablet press offers a secure password login system, an electronic audit trail (event log and alarm
  • Servos Find a Packaging Niche
    control possible. They support sophisticated data gathering, transmission, and analysis, as well as integration of 21 CFR Part 11 compliant audit trails. Unfortunately, those strengths are also PCs' weakness. "PCs are not like a PLC's ladder logic," explains R.A. Jones & Co. Inc. sales director Rusty

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