Validation test establishment baseline

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 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. 

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. 

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