Procedures signatures

Collection and analysis of vibration signatures is a complex procedure. By looking at a vibration spectrum, one can identify which components of the pump system are responsible for a particular frequency component. Comparison of vibration signatures at periodic intervals reveals if a particular component is deteriorating. The following example illustrates evaluation of the frequency composition of an electric motor gear pump system. 

Room-temperature fluorescence (RTF) has been used to determine the emission characteristics of a wide variety of materials relative to the wavelengths of selected Fraunhofer lines in support of the Fraunhofer luminescence detector remote-sensing instrument. RTF techniques are now used in the compilation of excitation-emission-matrix (EEM) fluorescence "signatures" of materials. The spectral data are collected with a Perkin-Elraer MPF-44B Fluorescence Spectrometer interfaced to an Apple 11+ personal computer. EEM fluorescence data can be displayed as 3-D perspective plots, contour plots, or "color-contour" images. The integrated intensity for selected Fraunhofer lines can also be directly extracted from the EEM data rather than being collected with a separate procedure. Fluorescence, chemical, and mineralogical data will be statistically analyzed to determine the probable physical and/or chemical causes of the fluorescence. 

GLP compliance for electronic records does not differ from GLP compliance for paper records. The increased access and distribution of records and documents enabled by electronic systems provide compliance challenges. There are many new questions to answer for example, what is the difference between electronic approvals and electronic signatures The solutions to these challenges lie in ensuring that system validation and management processes are in place, such as SOPs or procedures... 

CFR - Part 11 means that you must be qualified to do your work, your programming must be validated, you must have system security in place, and you must have change control procedures for your SAS programming. The current additional FDA guidance on 21 CFR - Part 11 is titled Guidance for Industry Part 11, Electronic Records Electronic Signatures—Scope and Application. ... 

The use of mass tagging reagents to analyze proteomic data has greatly improved the ability to compare samples for protein expression differences. However, a major limitation of the ICAT procedure (Section 1, this chapter) is that it can only compare two samples simultaneously, usually a test and a control. Even with the ECAT design (Section 2) using multiple lanthanide metals to make a series of different mass tag signatures, it is difficult to extend the... 

The anticipated prorated payment, if any, to the participant for participating in the trial A statement of dosage/frequency and the probability for random assignment to each treatment An explanation of whom to contact for answers to pertinent questions about the research and research participants rights and whom to contact in the event of a research-related injury to the participant A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled A place for signatures by the participant, physician, person obtaining consent, and witness (less signatures may be required) it depends on the policies and procedures of the particular IRB... 

Upon completion of the analytic test component, a laboratory director can review original data that provides evidence that the assay procedure was run correctly. Customarily, interpreted results are issued under the signature of a clinical laboratory director. 

If an exception to a SOP is to be made for an individual study, that exception must be authorized in writing by the study director, and the written authorization must be maintained with the raw data for the study. If a change in procedure represents a new standard way of doing things, then the SOP should be revised, and the revision approved (e.g., by signature) by laboratory management. 

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