System acceptance review

The first SOP that should be written is the SOP for writing SOPs. This SOP should contain the guidance for the content of each SOP, the numbering system for SOPs, and the system for review, revision, and acceptance of SOPs. Take the time to plan the system so it can grow with the lab and not become too cumbersome. 

After the qualification testing, a summary report should be written to summarize validation activities with a conclusion as to whether the instrument is suitable to be put into routine use. The report should highlight the objective and scope of the validation project, all the qualification test results, test exceptions, and a recommendation for system acceptance. All the test procedures, test results, and the summary report must be reviewed and approved by quality assurance and/or management before product use. 

The review and approval (system acceptance) will include information about the approvers. All validation documents have to be reviewed and approved with involvement of the quality assurance unit. Figure 18.12 is an example. 

Qualification is the process of demonstrating whether a computer system and its associated controlled process/operation, procedural controls, and documentation are capable of fulfilling the specified requirements. Sidebar 10-11 depicts the context of the qualification activities and the computer systems validation process. The physical components of the systems are reviewed and its specific elements, subunits, and parameters are documented. A qualification also serves to verify and document the acceptability of the design, implementation, integration, and installation of the computer system components. The execution of the qualification is the mechanism by which documented evidence is created that verifies that the computer system performs according to its predetermined specification. 

FINAL SYSTEM VALIDATION APPROVAL The signatories below have reviewed the validation package for the [name of the supplier (vendor), and name of system] computer system. The review included the assessment of the phase reports listed below, including details of the execution of approved test scripts, test phase conclusions based on test phase acceptance criteria, and resolution of items listed in issues log. The determined validated status is derived as a culmination of this review process. ... 

If the downstream system is a eheeking deviee and is not a separate eomputer system (i.e., it forms part of the funetionality of the eomputer system under review), then the whole system including the eheeking device must be considered eritieal. A regime of sampling the output of the eomputer system will not be accepted as a downstream quality check. 

Have modifications or additions to fire protection systems been reviewed or accepted by the safety department or property insurance carrier ... 

Consensus standards are the key to the voluntary standards system because acceptance and use of such standards foUow direcdy from the need for them and from the involvement in their development of all those who share that need. Consensus standards must be produced by a body selected, organized, and conducted in accordance with due process procedures. AH parties or stakeholders are iavolved in the development of the standard and substantial agreement is reached according to the judgment of a properly constituted review board. Other aspects of due process involve proper issuance of notices, record keeping, baHoting, and attention to minority opinion. 

Now you can reconsider the material balance equations by adding those additional factors identified in the previous step. If necessary, estimates of unaccountable losses will have to be calculated. Note that, in the case of a relatively simple manufacturing plant, preparation of a preliminary material-balance system and its refinement (Steps 14 and 15) can usefully be combined. For more-complex P2 assessments, however, two separate steps are likely to be more appropriate. An important rule to remember is that the inputs should ideally equal the outputs - but in practice this will rarely be the case. Some judgment will be required to determine what level of accuracy is acceptable, and we should have an idea as to what the unlikely sources of errors are (e.g., evaporative losses from outside holding ponds may be a materials loss we cannot accurately account for). In the case of high concentrations of hazardous wastes, accurate measurements are needed to develop cost-effective waste-reduction options. It is possible that the material balance for a number of unit operations will need to be repeated. Again, continue to review, refine, and, where necessary, expand your database. The compilation of accurate and comprehensive data is essential for a successful P2 audit and subsequent waste-reduction action plan. Remember - you can t reduce what you don t know is therel... 

Review the compressor building ventilation system to ensure that it has adequate capacity lo maintain acceptable temperatures in the co(n[>rcssor bays... 

However, the experimental evidence collected during recent years, concerning mostly the nickel-copper alloy systems, complicated this almost currently accepted interpretation of the alloy catalytic behavior (45). Chemisorptive and subsequent catalytic phenomena appeared to require a different approach for elucidation. The surface reactivity had to be treated as a localized quality of the atoms at the interface, influenced by their neighbors in the crystal lattice (78-80). A detailed general discussion of catalysis on alloys is beyond the scope of this review. In the monograph by Anderson (81) and in the review by Moss and Whalley (82), recently published, a broad survey of the catalytic reactivity of alloys may be found. 

There have been remarkably few reviews of the chemistry of decompositions and interactions of solids. The present account is specifically concerned with the kinetic characteristics described in the literature for the reactions of many and diverse compounds. Coverage necessarily includes references to a variety of relevant and closely related topics, such as the background theory of the subject, proposed mechanistic interpretations of observations, experimental methods with their shortcomings and errors, etc. In a survey of acceptable length, however, it is clearly impossible to explore in depth all features of all reports concerned with the reactivity and reactions of all solids. We believe that there is a need for separate and more detailed reviews of topics referred to here briefly. The value of individual publications in the field, which continue to appear in a not inconsiderable flow, would undoubtedly be enhanced by their discussion in the widest context. Systematic presentation and constructive comparisons of observations and reports, which are at present widely dispersed, would be expected to produce significant correlations and conclusions. Useful advances in the subject are just as likely to emerge in the form of generalizations discerned in the wealth of published material as from further individual studies of specific systems. Perhaps potential reviewers have been deterred by the combination of the formidable volume and the extensive dispersal of the information now available. 

When a polymer film is exposed to a gas or vapour at one side and to vacuum or low pressure at the other, the mechanism generally accepted for the penetrant transport is an activated solution-diffusion model. The gas dissolved in the film surface diffuses through the film by a series of activated steps and evaporates at the lower pressure side. It is clear that both solubility and diffusivity are involved and that the polymer molecular and morphological features will affect the penetrant transport behaviour. Some of the chemical and morphological modification that have been observed for some epoxy-water systems to induce changes of the solubility and diffusivity will be briefly reviewed. 

In reviewing intraarterial infusion of microencapsulated anticancer agents and its clinical applications, Nemoto (124) concluded that this mode of treatment can be used for a wide variety of tumors, providing remarkable therapeutic effects with minimal systemic toxicity. However, 25% of the treated tumors failed to respond, which was thought to be attributable to either inadequate catheterization, inadequate dose relative to tumor size, insufficient tumor vascularity, low drug sensitivity, or a combination of these factors. More carefully designed studies will be necessary before this technique is likely to meet with widespread acceptance. 

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