Baseline validation establishment

Section 3.3 Requirements Baseline Validation. Includes the approach and methods to validate that the requirements baseline established from requirements analysis is both upward and downward traceable to customer expectations, project and enterprise constraints, and external constraints. 

This baseline should include the incremental cost for production created by catastrophic machine failures and other parameters. If they are available or can be obtained, they will help greatly in establishing a valid baseline. 

During the implementation stage of a predictive maintenance program, all classes of machinery should be monitored to establish a valid baseline data set. Full vibration... 

Consequently, for a system that is in operational use and does not meet the criteria for retrospective validation, the approach should be to establish documented evidence that the system does what it purports to do. To do this, an initial assessment is required to determine the extent of documented records that exist. Existing documents should be collected, formally reviewed, and kept in a system history file for reference and to establish the baseline for the validation exercise. From the document gap analysis the level of redocumenting and retesting that is necessary can be identified and planned. 

Once the baseline data for heat distribution are established, the combination of in-process moisture analysis (of the load being dried) and heat or airflow distribution (for a loaded oven) will help the technologist understand the drying process for a product. In addition, other information learned will include the moisture level in the dried granulation can be reached without exposing the material to excess heat. This relationship will help QA evaluate the process during validation as well as audit the process if process deviations should be encountered. 

Lin and Wu [137] established a simple capillary zone electrophoresis method for the simultaneous analysis of omeprazole and lansoprazole. Untreated fused-silica capillary was operated using a phosphate buffer (50 mM, pH 9) under 20 kV and detection at 200 nm. Baseline separation was attained within 6 min. In the method validation, calibration curves were linear over a concentration range of 5-100 /iM, with correlation coefficients 0.9990. RSD and relative error were all less than 5% for the intra- and interday analysis, and all recoveries were greater than 95%. The limits of detection for omeprazole and lansoprazole were 2 fiM (S/N = 3, hydroxynamic injection 5 s). The method was applied to determine the quality of commercial capsules. Assay result fell within 94—106%. 

Natural history makers are validated when at baseline a strong relationship between the level of the marker and the ultimate clinical outcome of the disease has been established. These markers are often established in the placebo arms of early drug studies. Here the establishment of a sample repository can permit poststudy analysis to establish the veracity of a Type 0 marker. 

Validation of the neutralization system is one of the most critical, if not the most critical, aspects of the preclinical and clinical studies. Recall that assessment of the efficacy of a product in the time-kill kinetic study and the clinical simulation studies is based on the measurement of a bacterial population from an established baseline. Basically, these test methods are designed to capture a snap shot of the time-kill proAle so that when a sample is taken, immediate neutralization must take place. TheoreAcally, this provides an accurate enumeradon and subsequent calculation of reduction from a predetermined baseline. 

The enterprise shall perform a validation of the requirements baseline established during requirements analysis. Validation eonsists of the following two types of activities ... 

The enterprise conducts defined procedures to verify that each requirement and constraint described by the established functional architecture is upward traceable to the validated requirements baseline, and that all top-level system requirements and constraints recorded in the requirements baseline are downward traceable to the functional architecture. 

Section 3.5 Functional Verification. Includes a description of the approach and methods planned to verify that the functional architectore established from fimctional analysis is both upward and downward traceable to the validated requirements baseline. 

The procedure for an appropriate change-control-process shall be established with defining a unique baseline of the version of the SRECS and a definition of all configuration items (e.g., specifications, design documents, hardware/software modules, test plans and results, verification and validation reports, tools, change control procedures and effect analyses) of a baseline. 

Other support documentation generated during the CD-2 preparation phase include finalizing the PEP, updating safety and security documentation, completion of the NEPA and environmental documentation, development of a Construction Safety and Health plan, establishment of the Authorization Basis and Safety Management Systems for the project, validation of the baseline through an independent external review, and approval of design reviews and readiness assessments. 

Specifications and standards have long been an excellent means of disseminating best practices. A key driving force for specifications and standards typically has been the establishment of a common baseline for best practices, as well as alignment of the supporting industrial infrastructure to minimal requirements. Thus standardization presents an opportunity to promulgate the latest validated corrosion best practices across an industrial application area. 

It was observed that the creep data were readily fit to the two-term or two cell version of Eq 28. Qualitatively, two-terms for Eq 28 is suitable because the creep behavior of lead-free solders is usually a combination of bulk diffusion and fast diffusion processes as has been demonstrated by the apparent activation energy values cited previously. Values of the parameters used in Eq 28 are listed in Table 3 for a number of Pb-free solders and the Sn-Pb baseline alloy. Clech validated the resulting equations, using creep and stress-strain test results that are independent of those data used to establish the parameters in Table 3. 

Validating that a problem exists based on the measurements, for example, at-risk events. Analyzing the measurement system, the capability of the system, and establishing a process capability baseline is necessary for any process improvement. As example, the TCIR for one year has limited value. Over a multiyear period, a graph would show it is increasing... 

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