Documentation repeat testing

In all large and complex systems developed by contract developers, it is normally the practice to perform an SAT. The SAT is the set of activities comprising the system installation, start-up, operational testing, and user orientation performed by the software supplier/integrator in the operational environment. For the purposes of this book, the operational testing performed as part of the SAT is also known as the OQ2. If the SAT is conducted according to approved protocols, test results are properly documented, and test results reviewed and approved by the user and QA, it may not be necessary to repeat the installation and operational qualifications. This provides cost savings and can streamline the validation process. Refer to Sidebar 10-2. 

Test Specifications collate a number of individual test cases. The value of preparing effective test cases should not be imderestimated. Poor test cases will lead to a weaker measure of product quality than is possible from the activity and to an inconclusive overall result. These in turn will lead to delays whUe the uncertainty is considered problem resolutions are determined and documented, usually with revised test specifications and repeated testing. 

The Test Report must not exclude any test conducted including those repeated for failed tests. It may be combined in a single document with test results. A successful overall testing outcome authorizes the computer system for use. Test Reports are not necessarily prepared by QA however, they should be approved by QA. 

A maintenance program should document all tests, inspections, and faults cleared by a main and feeder circuit breaker. Lack of such a program will reduce the reliability of the electrical equipment.Molded case circuit breakers require no internal maintenance. They should be inspected for broken casing and loose connections after they operate to clear a fault and should be replaced after they have operated to clear two faults. Feeder circuit breakers, especially older circuit breakers, should be exercised (repeatedly opened and closed) whenever possible.f" Part of the initial commissioning of an electrical power system must include testing of the ground fault protection. ... 

Quality measurements have several elements. Quality assurance plans and quality control procedures are an essential beginning. In addition, it is necessary to have qualified scientists whose training needs to be documented and updated on a continuous basis. Quality measurements also require proper use of reference materials where available, and laboratories must repeatedly test their ability to perform through taking part in proficiency testing schemes. The provision of another essential element in quality measurements, namely validated methods, is the primary contribution from the work of AOAC. 

Nonstandardized methods should not be used as the sole methods within a paternity testing laboratory. In addition, a nonstandard method should only be used if it can be documented that the method is used in at least one other laboratory, thus making it possible to obtain a second opinion based on repeated testing. 

All measured values, calculations and findings are noted in the documentation. The documentation must be signed and dated by hand by the technician. Computer printouts must be dated and signed, too. Tests which do not pass must be documented, even if the respective components can be adjusted or repaired on the spot. Repeated tests must be marked as such. 

Laboratory tests used in the development of inhibitors can be of various types and are often associated with a particular laboratory. Thus, in one case simple test specimens, either alone or as bimetallic couples, are immersed in inhibited solutions in a relatively simple apparatus, as illustrated in Fig. 19.34. Sometimes the test may involve heat transfer, and a simple test arrangement is shown in Fig. 19.35. Tests of these types have been described in the literatureHowever, national standards also exist for this type of test approach. BSl and ASTM documents describe laboratory test procedures and in some cases provide recommended pass or fail criteria (BS 5117 Part 2 Section 2.2 1985 BS 6580 1985 ASTM 01384 1987). Laboratory testing may involve a recirculating rig test in which the intention is to assess the performance of an inhibited coolant in the simulated flow conditions of an engine cooling system. Although test procedures have been developed (BS 5177 Part 2 Section 2.3 1985 ASTM 02570 1985), problems of reproducibility and repeatability exist, and it is difficult to quote numerical pass or fail criteria. 

Data adequacy The key study was well conducted and documented. Supporting data include both human and animal studies. Animal studies covered acute, subchronic, and chronic exposure durations and addressed systemic toxicity as well as neurotoxicity, reproductive and developmental effects, cardiac sensitization, genotoxicity, and carcinogenicity. Other effects in animal studies occurred at much higher concentrations or with repeated exposures the latter are not relevant for setting short-term exposures. No effects other than narcosis occurred in rats and mice exposed at 200,000 ppm for various periods of time. Adjustment by a total UF of 10 results in a higher value (20,000 ppm) than from the cardiac sensitization test with dogs. ... 

In addition to these newly proposed test guidehnes, suggestions are being considered for new parameters to be included in the present repeated dose oral toxicity test (OECD TG 407) with more emphasis to be placed on detection of endocrine effects. The vahdation of the enhanced OECD TG 407 is now being reviewed by an international panel of reviewers. The peer review package, submitted to the panel and available at the OECD Web site for endocrine dismpters (OECD 2007b), includes the validation report, the draft and the current test guidelines, and a Secretariat document to support the peer review panel. 

Answer Peptic ulcer disease is most frequently secondary to either Helicobacter pylori infection or use of NSAIDs. The patient does admit to NSAID use (naproxen), but should also be checked for concomitant H. pylori infection at time of endoscopy or by a serology test. If the patient was found to have H. pylori, an appropriate eradication regimen should be prescribed. The patient should also be counseled to avoid NSAIDs. The patient should be prescribed a proton pump inhibitor for 8 weeks to heal the ulcer. A repeat endoscopy should be done at that time to document ulcer healing and rule out gastric cancer. In addition, the patient should be counseled to stop smoking, which is a risk factor for more severe peptic ulcer disease. 

The first and fastest tests simply categorize product components as protein, lipid, carbohydrate, ions or nucleic acids. Many of these techniques have been documented elsewhere for biological materials [18,20,22,23,29,30] but are repeated here to emphasize their utility in all staining, especially in the more difficult foods such as process cheese, lunchmeats etc., which are heavily buffered. Where such is the case, the pH of the unembedded product must be matched to that of the dye so as not to confound interpretation. 

Clinical studies have documented the rapid tolerance development from repeated exposures to DOM. Five volunteers were given 6 milligrams daily for three days. Objectively, psychological tests showed a decrease in responses. Subjectively, all found extremely intense effects on the first day, and all but one found it unpleasant. By the third exposure on the third day, all had diminished responses, ranging from only moderately strong to felt absolutely nothing. One... 

Consideration should be given to periodic revalidation to ensure the computerized operation remains capable of achieving the intended results. The extent of revalidation will depend upon the nature of the changes and how they affect the different aspects of the previously validated computerized operation. Unless circumstances demand, revalidation does not necessarily mean a full repeat of the validation life cycle. As appropriate, partial requalification may be acceptable. For instances in which new qualification testing is undertaken it is advisable to retain the original qualification summary reports in the validation file or quality system archives, marked superseded with cross-reference to the new documents. 

Operational verification of packaging components. A simulated production run is used to observe, assess, and document the performance of the equipment with packaging components. The behavior of the components on the equipment should be in accordance with the SOPs. Any discrepancies between the intended/planned and actual operation are corrected. After the corrections have been made, a simulated production run and the tests procedures are repeated and the results are documented. 

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