Results documentation

Users should be the prime participants in the preparation process so that the resultant documents reflect their needs and are fit for the intended purpose - hence the requirement that documents be reviewed as well as approved. You will need to be able to demonstrate that your documents have in fact been reviewed prior to issue. The presence of a signature on the front cover is not sufficient evidence. To demonstrate that documents have been reviewed you will need to show that nominated personnel have been issued with drafts for comment and that they have provided comments which have been considered by the approval authorities. A simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the review process you may undertake several revisions. You may feel it necessary to retain these in case of dispute later, but there is no compulsion for you to do so, providing you have evidence that the review took place. You also need to show that the current issue has been reviewed so your comment sheet needs to indicate document issue status. 

In much the same fashion as the use of " Th/ U or Th/ Ra disequilibria, the extent and rate of °Po scavenging from seawater can be estimated by comparison of its distribution with that of its grandparent, °Pb. Early results documenting distributions of °Po and °Pb in the oceans (Bacon et al. 1976 1988 Thomson and Turekian 1976 Nozaki et al. 1976 Nozaki and Tsunogai 1976 Cochran et al. 1983 Chung and Finkel 1988 see also Cochran 1992) showed that °Po was more rapidly removed from surface waters than °Pb ( °Po/ °Pb in solution < 1). At depth, however, °Po can be released to solution from sinking particles such that °Po/ °Pb in solution is >1 (Cochran et al. 1983 Bacon et al. 1988 Cochran 1992). 

The sections 4.1 to 4.4 comprised a thorough review of the relevant scientific literature with respect to organic farming and its impact on the environment and resource use. While each section focused on one environmental indicator, this section will now conclude by bringing together the individual results documented in the summarising assessment scheme, whieh eompleted each subsection. 

Proper documentation is required for all aspects dealt with so far in order to build confidence in the laboratoiy s results. Documentation is necessaiy to illustrate that every-day operation of the laboratory fully complies with the set requirements. 

Another key factor determining the emission levels is the bulk equivalence ratio ((l>) in the furnace, a parameter that describes the relative amounts of fuel and air. Levendis and co-workers (1996, 1998fo) have shown that for both coal and tyre (and for various blends thereof) the specific emissions, that is, the mass of a certain pollutant relative to the mass of fuel burned, vary systematically when the combustion environment changes from fuel-lean (low ) to fuel-rich (high [Pg.490]

Action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes and characteristics... 

As we shall see, the resultant document so intended to please that it broke the basic ethical rule of science that hypotheses must be consistent with facts. 

Incorporating these procedures and the resulting documents into the quality management system will afford a single point of control and archive for all validation procedures. 

If possible, a printout of the installation audit or system log file should be captured at the time of software installation and retained as documented evidence. In some cases, the supplier may provide internal diagnostic software that verifies the successful installation/connection of the computer technologies. A printout of any such diagnostic test results or reports should be retained as evidence. If it is not possible to capture this evidence, then the expected results of a successful installation must be indicated in the IQ protocol, and the actual observed results documented. 

Thus, in the language of the new TBT agreement, when a government acts to accept a voluntary standard to make it mandatory, the resulting document is a technical regulation. A measure used to ascertain compliance with a standard or technical regulation is a conformity assessment procedure. 

The intrinsic plasma membrane fluidity of a series of sarcoma cell lines with various degrees of adriamycin resistance was studied by ESR [91]. The results document a systematic increase in the order parameter, S, as the cells become more and more resistant. At the same time, a parallel increase in the sphingomyelin content was ob-... 

Fergusson et al. (2005) searched the literature and found 702 randomized clinical trials (87,650 patients) comparing SSRIs with either placebo or an active non-SSRI control medication. They found a statistically significant, more than two-fold increased risk of suicide attempts on SSRIs compared to placebo. The odds ratio of suicide attempts in SSRI-treated patients versus placebo patients was 2.28 (p = 0.02) and a 95% confidence interval (Cl) of 1.14-4.55. They also found an increased suicide risk between SSRIs and other medications, excluding tricyclic antidepressants. There was no difference between the SSRIs and tricyclics in suicide risk. Overall, their results documented an association between suicide attempts and the use of SSRIs. ... 

Reviewing technical reports to ensure that the information provided accurately reflects the generated results, documents any deviation from the study protocols, and gives appropriate conclusions. 

The decision to develop a pharmaceutical product transfers an active principle or compound from the resource-limited research laboratory into a new environment. In a multi-disciplinary approach the compound is subject to a variety of analytical, pharmacological, toxicological, and clinical tests and trials. From now on methods, results, documentation and the materials created are under strict scrutiny exerted by the developing organization itself and finally by several authorities. Research activities are hardly ever subject to such surveillance and control, concerning, for example the precision and consistency of methods and results. It usually takes time for a researcher to fully acknowlewdge and accept this fact. 

All laboratories need to demonstrate that their methods are fit for the purpose for which they are intended. The process of obtaining data to demonstrate this fitness for purpose and the resulting documented evidence is called method validation. The purpose of method validation is to determine that one or more of the performance characteristics of the method is satisfactory so that the analytical results obtained will be fit for their intended purpose. 

IL-12 is a multifunctional cytokine capable of inhibiting neovascularization, Because the human IFNy-inducible protein 10 (IP-10) can also inhibit neovascularization, IP-10—induced by IL-12 through the intermediate cytokine IFNy—was tested to determine if it might be a mediator of IL-12 angiogenesis inhibition. Murine IL-12-induced murine IP-10 expression in mouse splenocytes and human IFNy-induced human IP-10 expression in purified human endothelial cells suggest that IL-12 can induce IP-10 expression in certain cells. These results document the important role of IP-10 as a mediator of angiogenesis inhibition by IL-12 and raise the possibility that IP-10 may also contribute to the antitumor effect of IL-12. ... 

Consistency In the absence of procedures, five technicians are apt to perform the same task five different ways. In the absence of a procedure, each individual has the freedom to personalize the task at hand. Inconsistency produces undesirable results. Documented procedures bring uniformity into the lubrication task while keeping everyone on the same page. 

Test attributes procedures and acceptance criteria selection of batches testing frequency storage containers, conditions, and period, as well as data evaluation are discussed in great detail. Data evaluation considers out-of-specification results. Documentation covers protocols and protocol amendments, deviation reports, out-of-specification reports, test results and raw data, and stability reports. 

A subprocess produces a result, e.g. a flowsheet of the essential part of the plant. The flowsheet determines the following subprocess, e.g. the analysis of the design by simulation. We call this mutual relationship between subproducts of one subprocess and later subprocesses reactivity. This can also happen backwards One may detect an error in a resulting document of a subprocess. The error, however, has been made in a preceding subprocess, which has to be taken up again. 

Nevertheless, the research results documented in this volume will find their way into industrial application in due time because they have addressed the right problems and delivered the right concepts and methodologies. The corresponding ideas and concepts have been proved by prototypes, but not in an industrial setting. We are optimistic that this will be done in the next future. 

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