Validation reason for

It is unnecessary to remove invalid or obsolete documents if you provide staff with the means of determining the pertinent issues of documents to use. There are often valid reasons for retaining obsolete documents. What may be obsolete in one situation may not be obsolete in another. In simple terms an obsolete document is one which is no longer required for operational purposes. As stated earlier, there are cases where various issues of the same document may need to be used and in such cases none of the documents is obsolete. One may need to remove copies of previous versions of a document but retain the master for reference purposes. You cannot demonstrate to an assessor that you corrected a deficiency if you don t retain the version that contained the deficiency as well as the subsequent version. 

For generic bioequivalence the generic manufacturer would be expected to use the same chiral material as the innovator (most probably a racemic mixture or pure active isomer, though it is possible that in some rare instances the innovator might have discovered a valid reason for using some mixture of R and S other than 50/50). Thus, as with development bioequivalency, it would not normally seem necessary to use stereoselective assays for the separate determination of R and S isomers. However, one can conceive of possible situations where clinically significant differences in R-to-S ratios could be caused by even relatively small differences in absorption rate [6,7]. 

It has been observed that there are two valid reasons for the segregation of PS II and PS I by a distance of 10 nm. These are as follows ... 

Each lower sub-branch (near-root cause) is then considered in turn to determine if any of the potential root causes on that sub-branch is a valid reason for why the causal factor existed at the time of the incident. Valid root causes are recorded and invalid causes are eliminated. 

Each test report or calibration certificate shall include at least the following Information, unless the laboratory has valid reasons for not doing so ... 

In-house mating is recommended in the Redbook. There are no valid reasons for this. Time-mated animals are available from many reputable laboratory animal breeders and their use has been validated over several decades. The use of time-mated animals allows a predefined number of pregnant females to be ordered and allocated to the study each day so that all procedures can be planned in advance according to the resources available. Also, the supplier has a large colony of breeding males and females available, providing a wide gene pool. 

There is no standard report form offered because the standard requires it be completed and in accordance with any specific instructions in the test or calibration methods (subsection 5.10.1). It is noteworthy that the general notes to subsection 5.10 do allow a simplified report to be issued to internal clients, as long as the full information is readily available in the laboratory. There are 11 items that are required on test reports and calibration certificates (unless there are valid reasons for their exclusion) plus five additional items that cover aspects of interpretation and six items when sampling has also been carried out as part of the test. Increasingly test reports are submitted electronically. This is referred to in the standard (subsection 5.10.7) and is allowed as long as the requirements of the standard are met. Of importance is the integrity of the report and the nature of the signature when the report is sent by e-mail or via the Internet. 

There is a valid reason for this commingling of the reports of the effects of this chemical and plant, however. In many peoples minds, the two materials are felt to be exclusively monoamineoxidase inhibitors, and to be interchangeable. I recently read the following bit of advice somewhere on the internet. "If you really want to get off on shrooms, take some harmaline or Syrian Rue seeds along with them." This one phrase embodies a number of popular myths in the psychedelic drug subculture. Let me try to unravel this tangled knot. 

The rejection of outliers from analytical data is one of the most vexed topics. The only valid reason for rejecting a piece of data is when a discernible cause can... 

There are several valid reasons for removing sulfur from petroleum fractions. These include ... 

There often are valid reasons for developing subclassifications of basic waste classes (i.e., classifications subordinate to those based... 

However, there is still no valid reason for considering the H2 receptor antagonists to be tumorigenic, and when studies have detected some excess incidence of gastric cancer in long-term users of H2 receptor antagonists this... 

Meetings outside Greece are allowed, provided that there are valid reasons for this such as most of the invitees are from outside Greece. 

The blind application of statistical tests to retain or reject a suspect measurement in a small set of data is not likely to be much more fruitful than an arbitrary decision. The application of good judgment based on broad experience with an analytical method is usually a sounder approach. In the end, the only valid reason for rejecting a result from a small set of data is the sure knowledge that a mistake was made in the measurement process. Without this knowledge, a cautious approach to rejection of an outlier is wise. 

The presence of so many anomalies in the literature and folklore of psychedelia favors an alchemical interpretation, that is to say, the consciousness we seek to alter is at least as important as the substance we use to alter it with. The same key may open many different doors, but what might lie behind each portal will remain indeterminate until entered. There are valid reasons for Western medicine s preference for... 

However, by the present time these ways of improving the thermoelectric figure of merit have practically exhausted themselves. Despite the numerous efforts, the increase in the figure of merit is insignificant. Therefore, it is only natural to ask whether this situation is a casual one or there are valid reasons for these restrictions. 

When a risk assessment under review deviates from the use of standard factors, there may in many cases be a valid reason for so doing the assessment may reflect particular conditions at or near a specific site. The ability to annotate findings in Risk Assistant provides a ready means for reviewers to indicate the importance and/or validity of deviations from standard procedures. 

Finally, local statistical fluctuations of thermodynamic and volumetric quantities [7] can also be predicted by using Cp(T) and CV(T). These fluctuations are often neglected in discussions of the thermodynamic properties of polymers. They are, however, important in determining certain aspects of the performance of materials. The local fluctuations of volume, density and enthalpy in polymers and in other amorphous solids have been extensively studied experimentally and theoretically [8-21]. They have also been used to provide valid reasons for choosing between competing models for the structures of polymeric glasses and melts [22]. 

After only six months, I heard he was now seUing the business and wanted out. He said he didn t want to risk losing any more money and didn t like how it consumed his family life. These are valid reasons for getting out, but ones that clearly illustrate that not everyone is cut out to be an entrepreneur, a realization that is totally okay. IT s better to come to that realization sooner rather than later. 

Sometimes commencement dates are expressed in the as soon as possible category. Valid reasons for this may relate to the urgency of the project. However, urgency can arise for a number of reasons. For example, this may arise due to the need to make use of particular plant as soon as available risk of failure of existing works risk of loss of funds for the project (e.g. due to the approach of the end of the financial year for public sector clients) and political urgency. 

Sometimes the contract is timed to run through the winter period. While there may be valid reasons for this, such as enviromnental concerns, concerns about damaging trade or tourism over the summer period, or more ready availability of plant and labour, fixing the timing in the winter period automatically increases the hazards to construction. However, there may be marginal benefits in carrying out the work during the winter period in terms of hazards to the public since there may be fewer people aroimd the site in this period. 

This was the state of diazo-chemistry when Hantzsch published an elaborate criticism which produced a profound impression and opened a violent controversy with Bamberger. Hantzsch asserted that there was no valid reason for the nitrosamine formula for the isodiazo-compounds, which on hydrolysis give normal diazo-compounds. The different behaviour of sodium and silver salts on alkylation is due to tautomerism. Normal and isodiazo-compounds have identical constitutions, and hence the difference must be due to stereoisomerism, which arises from the fact that the three valencies of nitrogen do not lie in a plane, an assumption which explained the isomerism of the oximes. The only new experimental evidence Hantzsch gave was the preparation of a very unstable isomer of Fischer s potassium diazobenzenesulphonate (see p. 823), assumed to have the same structure, and hence the two salts were stereo-isomers, Fischer s salt being the syn- and the new (iso-) salt the anti-ioim ... 

The existence of markets for recycled materials is a key part of any recycling operation. It does no good whatsoever to separate and process materials if they do not find uses in new products. The packaging industry has an obligation to increase its use of recycled materials. While there obviously are applications for which only virgin materials are suitable, they should not be specified unless valid reasons for the exclusion of recycled materials exist. Writing specifications based on performance rather than material content may aid in avoiding the unnecessary exclusion of recycled maieriais. 

There are valid reasons for declaring that the periodic system was essentially discovered in 1862 by De Chancourtois, a French geologist. De Chancourtois appears to have taken not just an important step in the story of the periodic system but, in many ways, the single most important step. It was he who first recognized that the properties of the elements are a periodic function of their atomic weights, a full seven years before Mendeleev arrived at the same conclusion. 

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