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The System of Process Audits for Medical Industry
Pokorná, Klára ; Moravcová, Zdeňka (referee) ; Bartes, František (advisor)
The Master’s thesis deals with the area of conducting process audits in a large multinational corporation focused on manufacturing and distribution of medical devices, which has a subsidiary in the Czech Republic. The thesis discusses the analysis of the current set up of the internal audits‘ system in the corporation and there are changes of the quality system being proposed on the basis of the analysis, whose aim is to achieve a full compliance with the requirements of the US administration FDA, the standard ISO 13485 as well as the recent requirements on performing process audits. The emphasis is also put on the setting of the system such that it provides the highest possible added value for its users, can be easily implemented in practice and is flexible as well.
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The System of Process Audits for Medical Industry
Pokorná, Klára ; Moravcová, Zdeňka (referee) ; Bartes, František (advisor)
The Master’s thesis deals with the area of conducting process audits in a large multinational corporation focused on manufacturing and distribution of medical devices, which has a subsidiary in the Czech Republic. The thesis discusses the analysis of the current set up of the internal audits‘ system in the corporation and there are changes of the quality system being proposed on the basis of the analysis, whose aim is to achieve a full compliance with the requirements of the US administration FDA, the standard ISO 13485 as well as the recent requirements on performing process audits. The emphasis is also put on the setting of the system such that it provides the highest possible added value for its users, can be easily implemented in practice and is flexible as well.
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Audit of application systems
Smola, Martin ; Svatá, Vlasta (advisor) ; Telíšková, Vladana (referee)
This thesis is concerned with audit of application system in copany MCR Technology s.r.o., identification of problem areas and following suggestion of possibilities in solving problems, which were identified pursuant to realized audit. First part is focused on general definition and characteristic of audit with view to his goals, mission and effective realization. Then is thesis concerned with audit of information systems, where are defined instruments and methodics for IS audit realization. Second part is focused on audit of application system in company. Audit involves selection of relevant application control form COBIT methodics and their modification for conditions of small copany. After it follows realisation of audit base on select control, summary of audit finding in audit report and indentification of problem areas. The subject of the third part is draft of solutions of problem areas in application system which were identified pursuant to audit.
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