Verification accomplishment

With reference to Table 9.13, the following deliverables are required as evidence of verification accomplishment at each level of system integration (refer to Fig. 1.3) ... 

To accomplish this, you need to specify either in the quality plan or the documented procedures, the inspections and tests you intend to carry out to verify that the product meets specified requirements. In Part 2 Chapter 4 there is a description of a Design Verification Plan and this includes a specification of the tests and inspections to be performed on each production item as a means of ensuring that the qualified design standard is being maintained. This requires that you produce something like an Acceptance Test Plan which contains, as appropriate, some or all of the following ... 

As another example, increased reliance on the control activities of national systems is being considered, with the potential for serious departure from the requirement of independent verification In their place, it is suggested that the Agency s new rights will allow it to accomplish the same purpose as classical safeguards, through increased investigation when... 

The derivation and experimental verification of the MMHS model represented a significant accomplishment and a natural plateau for film models. To be sure, there are general criticisms of film models and more specific criticisms of the MMHS model [6], However, overall the MMHS model should be recognized as a robust but simply applicable model which serves to demonstrate how factors such as intrinsic solubility of the acid drug, ionization and pA of the drug, and concentration of the reactive base all contribute to increasing the dissolution rate and mass transfer. 

Periodic revalidation of a system can be accomplished by performing another PQ for that system however, a simplified version is often used. This task has been alternately described as re-calibration, recertification or performance verification. Regardless of what it is called, the accepted strategy should be defined in an SOP and the specific procedure... 

Process variography provides verification whemer current TSE is below a priori determined, acceptable levels or not. For 0-D, this may be accomplished, for example by performing a replication experiment on me complete sampling procedure ten times (independently). It is essential mat replication mcludes all aspects of me current sampling process from primary samplmg to analytical result. McClellan and Kowalski [18] gives a brief delineation of me so-called replication experiment , which can be employed m me 0-D as well as in me 1-D domains. 

Not all solvents are equally suitable for spreading monolayers. The requirement that the solvent evaporate completely is self-evident. It has been suggested that if the organic solvent dissolves much water, the properties of the monolayer will be different from those in which no water is trapped. Verification that no artifacts are entering the observations from the solvent may be accomplished by conducting duplicate experiments with different solvents. 

Fig. 11-15). Replication of DNA does not begin until the cell has had time to repair as much damage to DNA as is possible.2284 As mentioned in Box 11-D, the cancer suppressor protein p53 is an essential component of the checking process.224 A second checkpoint, the G2 checkpoint, at the end of the G2-phase (Fig. 11-15) requires verification that all DNA of all chromosomes has been replicated, checked for damage, and repaired if necessary. Control of these processes is accomplished by a mechanism first identified in... 

To perform this verification three narrow fractions of linear polystyrene denoted as A, B, and C were investigated to determine their molecular weights. This task was accomplished by applying velocity as well as equilibrium sedimentation. In addition, these three individual fractions were combined according to a known weight ratio into a new polydisperse sample denoted as P. Sample P was also subjected to equilibrium sedimentation. All samples were investigated in cyclohexane at 35°C (near the 0 temperature) see Table I. 

The IQ is often the first validation activity completed when the lyophilizer arrives at the final installation site. Implementation of the protocol may begin as the lyophilizer is being installed. For example, verification of the electrical wiring and piping may be accomplished as part of the assembly activities. The appropriate approach to completing the IQ is dependent on the specific circumstances of the project. 

The IQ testing will require a number of test and verification procedures to be satisfactorily carried out and documented to ensure all components of the computer system are correcdy installed and recorded, demonstrating that the computer system is in a state of readiness to proceed to OQ. To accomplish this the following verification/test procedures must be covered by IQ protocol ... 

The validity of any comparative study is dependent on the reliability of the identification of the samples in the study. Not all researchers are experts in the field of identification of samples, nor do all researchers have quick and ready access to expert systemetists who can accomplish the task of identification. The importance of verification of sample identity for comparative studies is vital. We describe several methods by which researchers can obtain and identify samples from the wild, and we suggest methods by which voucher samples can be obtained for future reference to these collected samples. We outline alternatives to collection of samples from the wild, such as purchase from stock centers and biological supply companies. Museum collections can also be extremely helpful in obtaining complete organismal samples for comparative studies. 

The prediction of rocket propellant specific impulse, as well as impulse under other conditions, may be reliably accomplished by calculation using as input the chemical composition, the heat of formation, and the density of the component propellant chemicals. Not only impulse but also the composition of exhaust species (and of species in the combustion chamber and the throat) may be calculated if the thermodynamic properties of the chemical species involved are known or can be estimated. The present standard computer code for such calculations is that described by Gordon and McBride.44 Theoretical performance predictions using such programs are widely used to guide propellant formulation efforts and to predict rocket propellant performance however, verification of actual performance is necessary. 

Such demonstration may be accomplished by means of the partial removal of a shroud or a visual inspection of the interior of an enclosed space from its entrance, etc. (CWC, Verification Annex, Part X, para. 50). 

A further example concerns the verification of the theory of aromaticity. Synthesis of the eight-membered analog of benzene, cyclooctatetraene 71 (Scheme 1.22), accomplished in 1911 by Willstadter, was an outstanding achievement in its own right. Even more important was elucidation of the nonaromatic character of this molecule. This finding provided a powerful impact on the studies aimed at the elaboration of a more consistent explanation of aromaticity phenomena. 

Verification activities should be based on objective information, limited to the subject matter of the Treaty, and carried out on the basis of full respect for the sovereignty of State Parties and in the least intrusive manner possible consistent with the effective and timely accomplishment of their objectives. Each State party, however, shall refrain from any abuse of the right of verification . 

Purchasing— Requires purchased product to conform to specified requirements. This is accomplished through vendor assessments, clear and accurate purchasing data, and verification of purchased product where apphcable. 

In-plant quality control and routine acceptance testing by property verification organizations such as the Hardwood Plywood Manufacturers Association and the National Particleboard Association require a method more efficient than the chamber for routinely monitoring trends in emission characteristics of products. The relationship between chamber and the small scale desiccator test observations is illustrated by a series of 76 tests accomplished during the past year on hardwood plywood wall panel products at a chamber loading rate of 0.29 sq ft per cu ft ... 

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