Quality assurance confidentiality

An engineer surveyor employed by an insurance company will often be used to investigate claims, and each claim investigation adds something to his experience of failures. At the same time, he must observe strict confidentiality. To quote from a quality assurance manual ... 

The report is filed in the confidential Quality Assurance files. 

There are many more questions involved in these instances of splitting studies into various, practically independent parts. The question of, e.g., the various problems of Quality Assurance involvement with regard to the Quality Assurance statement in such fragmented studies will be investigated in more detail in section 4.5 (see page 163). The existence of such a great number of more or less unresolved issues within the conduct of multi-site studies finally led to their broad discussion and resolution in an OECD Consensus Document (OECD, 2002). A further problem, which cannot be resolved in the context of GLP, is the question of confidentiality and of various shades of competitor relationships. These issues have to be dealt with in the context of the contractual provisions and need not be considered further in the context of this book. 

FIGURE 28.2 (See color insert following page 40). Contract manufacture business model (CDA, confidential disclosure agreement cGMP, current good manufacturing practice QA, quality assurance). 

Provision of starting Quality control and assurance Confidentiality... 

The FDA guidance on pharmacoepidemiologic studies states "The quality control (QC) and quality assurance (QA) plan for the construction of the analytical data set(s) and analysis of data should be clearly described. QC consists of the steps taken during the analysis to ensure that it meets pre-specified requirements and that it is reproducible." [17] In addition, steps taken to ensure confidentiality and security of the data should be prespecified. 

The qualification body should operate according to a quality assurance programme giving consideration also to the independence, impartiality and confidentiality of that body. 

AIMS is used in over 50% of the hospitals in Australia and in 2005 it was adopted by the New Zealand Accident Compensation Corporation. The AIMS data remains confidential and is protected from legal actions under the Australian Commonwealth Quality Assurance legislation. 

The Office of Internal Oversight shall also carry out oversight audits covering confidentiality and quality assurance. The latter shall be conducted in accordance with current ISO auditing standards. 

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