Test results, summary

In addition to review of test results, summary data, investigation reports, and other data, the print of the system should be reviewed when conducting the actual physical inspection. As pointed out, an accurate description and print of the system is needed in order to demonstrate that the system is validated. 

Table 1. Test results summary of coal and rock physical and mechanical parameters.

Motor carriers are required to make Part 382 alcohol and drug records available for inspection. The California Highway Patrol (CHP) uses return-to-duty and follow-up test results to monitor drivers who are motor carriers. Any drug or alcohol testing consortium, as defined in 382.107 of the FMCSRs, must mail a copy of all drug and alcohol positive test result summaries to the CHP within 3 days of the test (only for those drivers employed by motor carriers who operate terminals in California). 

A laboratory information management system (LIMS) is a computer or computer network used to automate the acquisition and management of raw analytical data. In its simplest form, it tracks samples and test results through analytical laboratories and provides summaries of the status of these samples and tests. In its most advanced form, the system is interfaced to the laboratory s instmmentation and communication network to allow automation of data gathering, compilation, and reporting. 

Table 17 Summary of tensile strength test results for Sample 4 ...

Summary of Mechanical Testing Results of Precharged Steels with High-Pressure Gaseous Hydrogen at 20,000 psi and 100°C for 8 Days... 

Reference authors/year tested Method of assessment Results Summary comments... 

The six areas of proof previously discussed also provide a comprehensive package of evidence in support of the GALP. Each area is supported with specific documentary evidence, such as test results, SOPs, manuals, and code, and with testimonial evidence in the form of evaluations, interpretations, and summary reports. 

The medical records of the volunteers who received cholinesterase-reactivating chemicals consisted of the test protocol, physicians orders, nursing notes (Including clinical observations), a checklist of symptoms, and laboratory and performance test results. The reports of physicians examinations and physical findings were generally not Included. Volunteers were identified by number. The Committee on Toxicology s assessment was based on records and summaries provided by the Department of the Army and NRC staff. The procedures were described fully in Volume 1. In most cases, the analysis was based on summaries of drug administrations prepared by a consultant to the Panel. 

Particulate matter was determined in ten vials/ampoules, each spiked with approximately 500 particles of 40- im glass beads. Samples were taken from each individual needle at the end of vial washing at set operational parameters of vial/ampoule washer and analyzed to determine the reduction in particulate level. The results were compared with negative and positive controls. The summary of test results is provided in Table 2. 

Eollowing is the summary of test results achieved on three individual sterilization cycles of the freeze-drying unit. The results of the three runs met the acceptance criteria of exposure time, exposure temperature. 

A summary of UV -Vis measurements and cyclic voltammetry testing results for silafluorenyl copolymers are provided in Tables 1 and 2, respectively. 

Validation activities, testing, acceptance criteria, and results Summary of deviations, problems, and mitigations... 

For simple analytical instruments, a simple table to summarize the qualification testing, acceptance criteria, results, and pass/fail decision of the tests will be sufficient since there are fewer tests that are required and the tests are usually relatively simple. For complex analytical systems, a more complex table often referred to as a traceability matrix which traces the requirements, testing, acceptance criteria, test results, and storage locations of the validation documents, test data, and other supporting documents is usually included in the summary report for easy reviewing and quick references. 

A validation report is a written document that cross-references the validation protocol, summarizes the results obtained, describes any deviations observed, and draws the necessary conclusions, including recommending changes required to correct deficiencies for the qualification and validation performed [5]. In this report it is required to present both the results and conclusions and the secure approval of the study. The report should include a summary of the procedures used to clean, sample, and test as well as the physical and analytical test results or references for the same. The conclusions regarding the acceptability of the results should also be included. Other information would be the status of the procedures being validated, any recommendations based on the results, or any relevant information obtained during the study. These include, re validation practices (if applicable), the approved conclusions, and any deviations of the protocol that might have occurred. In cases where it is unlikely that further batches of the product will be manufactured for a period... 

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. 

Protocol Summary. A summary of the protocol documentation. including an analysis of the test results, the compliance audit of the system, and any system modifications should be submitted to the computer systems validation committee for their review and approval. It is recommended that the system not be used until final validation approval is received from the committee. 

Federal Regulations This document provides a summary of (and links to) the relevant sections of the Federal Food, Drug, and Cosmetic Act, including 21 Code of Federal Regulations (CFR) part 210 (CMPs for Manufacturing 21 CFR Part 211 (GMS for Finished Pharmaceuticals) and Guidance Documents for NDAs, ANDAs, and Out of Specification (OOS) Test Result Reporting. 

TABLE V, - Summary of Test Results For Treated and Untreated Basswood... 

The results from each study are considered on a case by case basis and the subsequent analysis and interpretation will be dependent on the type of study and the data collected. Generally, data comparison is made between test and control substances. Standard analysis for the majority of skin irritation studies includes a breakdown of the range of assessment grades elicited by each substance tested, a summary of subjective comments and some form of statistical analysis. 

Table 2. Summary of gas exchange data from stoppered culture tests using A. annua. Two sample t test results ...

The FDA s lot release regulations allow the agency to require manufacturers to submit samples of any licensed biological products for testing [24], Manufacturers must submit to CBER representative samples of each lot, a lot release protocol, and a summary of the test results. Lots may not be released until CBER authorizes an official release. However, CBER does not require lot release in all circumstances. 

HIV-1 present in culture supernatant fluids was quantified by Q-RT-PCR with readout in log copies per milliliter and the endogenous viral RT assay on cell supernatant with readout in log counts per minute per milliliter. Although the two methodologies measured different parameters, i.e., viral RNA versus active RT enzyme, test results were not markedly different from each other. A summary of these data expressed as effective concentration to reduce the viral RNA or the RT activity by 90%, EC90, for the three HIV-1 viral strains is provided in Table 1. 

Table 2 Summary of in vitro testing for selected experimental agents exhibiting favorable IC50 PDE5 test results...

Testing consisted of in vitro determination of androgenic/antiandrogenic activity on mouse mammary carcinoma Shionogi cells and in vivo determination of systemic antiandrogenic activity of immature male rats. A summary of these testing results is provided in Table 1 where ... 

Figure 18. Summary of pre-engineered building test results...

Table I - Summary of Sustained Burning Test Results...

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