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1

FEDERAL AVIATION ADMINISTRATION. FAA DAR, DAS, DOA, and SFAR part 36 directory. [Washington, D.C.?]: U.S. Dept. of Transportation, Federal Aviation Administration, 1996.

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2

United States. Food Safety and Inspection Service., ed. Meat and poultry inspection regulations (as reprinted from 9 CFR part 200 to end). [Washington, DC]: U.S. Dept. of Agriculture, Food Safety and Inspection Service, 2004.

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3

United States. Agricultural Marketing Service. Poultry Programs. Regulations governing the inspection of eggs (Egg Products Inspection Act): 7 CFR part 57 : effective August 27, 1999. Washington, D.C: U.S. Dept. of Agriculture, Marketing and Regulatory Programs, Agricultural Marketing Service, Poultry Programs, 1999.

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4

J, Iannello C. y John F. Kennedy Space Center, eds. Evaluation of cable harness post-installation testing: Part B. Kennedy Space Center, FL: National Aeronautics and Space Administration, Kennedy Space Center, 2011.

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5

United States. Food Safety and Inspection Service. Meat and Poultry Inspection Regulations (As reprinted from 9 CFR Part 200 to End), January 2010. S.l: s.n., 2010.

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6

Spencer, Rosalyn. The inspection of nursery education inspection report [for] Burley Park Early Years Centre, Burley, Leeds ...: Date of inspection 4/9/97. [London]: Ofsted, 1997.

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7

Ford, Ian. Inspection: Part Two. Independently Published, 2018.

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8

Ford, Ian. Inspection: Part One. Independently Published, 2017.

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9

Ford, Ian. Inspection: Part One and Two. Independently Published, 2018.

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10

Ten CFR Part 52 Construction Inspection Program Framework Document. USGOV, 2004.

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11

Pelt-Verkuil, E. van, W. B. van Leeuwen y R. te Witt. Molecular Diagnostics : Part 2: Clinical, Veterinary, Agrobotanical and Food Safety Applications. Springer, 2017.

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12

Pelt-Verkuil, E. van, W. B. van Leeuwen y R. te Witt. Molecular Diagnostics : Part 2: Clinical, Veterinary, Agrobotanical and Food Safety Applications. Springer, 2018.

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13

Pelt-Verkuil, E. van, W. B. van Leeuwen y R. te Witt. Molecular Diagnostics : Part 2: Clinical, Veterinary, Agrobotanical and Food Safety Applications. Springer, 2017.

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14

England, Great Britain: Highways. Design Manual for Roads and Bridges : Vol. 3 : Highway Structures : Inspection and Maintenance, Section 1 : Inspection, Part 4: Inspection of Highway Structures. Stationery Office, The, 2017.

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15

Agency, Highways. Design manual for roads and Bridges : Vol. 3 : Highways structures : inspection and maintenance, Section 1 : Inspection, Part 5: Inspection of highway Structures. Stationery Office, The, 2007.

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16

Agency, Great Britain: Highways. Design manual for roads and Bridges : Vol. 3 : Highway structures : inspection and maintenance, Section 1 : Inspection, Part 4: Inspection of highway Structures. Stationery Office, The, 2007.

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17

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 1 : Inspection, Part 4: Inspection of Highway Structures. Stationery Office, The, 2020.

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18

Manual of Concrete Practice: Part 2 : Construction Practices and Inspection ; Pavements. Amer Concrete Inst, 1987.

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19

executive, Health and safety. Best Practice for Risk Based Inspection of Part of Plant Integrity. Health and Safety Executive (HSE), 2003.

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20

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 1 : Inspection, Part 6: Inspection and Records for Road Tunnel Systems. Stationery Office, The, 2020.

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21

Practical Guide to Inspection, Testing and Certification of Electrical Installations: Conforms to IEE Wiring Regulations/BS 7671/Part P of Building Regulations. Routledge, 2008.

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22

Kitcher, Chris. Practical Guide to Inspection, Testing and Certification of Electrical Installations: Conforms to IEE Wiring Regulations/BS 7671/Part P of Building Regulations. Taylor & Francis Group, 2009.

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23

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 3 : Repair, Part 5: Inspection of Buried Concrete Box Structures. Stationery Office, The, 2020.

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24

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 1 : Inspection, Part 7: Non-Destructive Testing of Highways Structures. Stationery Office, The, 2020.

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25

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 3 : Repair, Part 5: Inspection of Buried Concrete Box Structures. Stationery Office, The, 2019.

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26

England, Great Britain: Highways. Design Manual for Roads and Bridges : Vol. 3 : Highway Structures : Inspection and Maintenance, Section 1 : Inspection, Part 7: Non-Destructive Testing of Highway Structures. Stationery Office, The, 2019.

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27

Agency, Highways. Design manual for roads and Bridges : Vol. 3 : Highways structures : inspection and maintenance, Section 1 : Inspection, Part 5: Structural assessment of bridges with deck Hinges. Stationery Office, The, 2009.

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28

Meat and Poultry Inspection Regulations, (As reprinted from 9 CFR Part 200 to End), January 2004, *. [S.l: s.n., 2004.

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29

Agency, Great Britain: Highways. Design manual for roads and Bridges : Volume 3 Highway Structures: Inspection. . Section 4 Part 20 BD81. Stationery Office, The, 2002.

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30

Staff, Stationery Office. Design Manual for Roads and Bridges Highway Structures - Inspection and Maintenance Section 1 Inspection Part 7 Advice Notes on the Non-Destructive Testing of Highway Structures. Stationery Office, The, 2004.

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31

Thompson, Donald O. Review of Progress in Quantitative Nondestructive Evaluation: Volume 8, Part a and B. Springer, 2013.

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32

Thompson, Donald O. Review of Progress in Quantitative Nondestructive Evaluation: Volume 8, Part a and B. Springer London, Limited, 2013.

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33

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 1 : Inspection, Part 5: Risk Management and Structural Assessmentof Concrete Deck Hinge Structures. Stationery Office, The, 2020.

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34

Agency, Highways. Design manual for roads and Bridges : Vol. 3 : Highways structures : inspection and maintenance, Section 1 : Inspection, Part 7: Advice notes on the non-destructive testing of highway Structures. Stationery Office, The, 2006.

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35

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 1 : Inspection, Part 7: Advice Notes on the Non-Destructive Testing of Highway Structures. Stationery Office, The, 2017.

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36

England, Highways. Design Manual for Roads and Bridges : Vol. 8 : Traffic Signs and Lighting, Section 3 : Lighting, Part 1: Road Lighting Inspection. Stationery Office, The, 2020.

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37

Kitcher, Christopher James. Practical Guide to Inspection, Testing and Certification of Electrical Installations; Conforms to Iee Wiring Regulations / Bs 7671 / Part P of Building Regulations. Taylor & Francis Group, 2008.

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38

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 2 : Maintenance, Part 2: Maintenance Painting of Steelwork. Stationery Office, The, 2019.

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39

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 2 : Maintenance, Part 3: Maintenance of Road Tunnels. Stationery Office, The, 2020.

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40

Kitcher, Christopher James. Practical Guide to Inspection, Testing and Certification of Electrical Installations: Conforms to IEE Wiring Regulations / BS 7671 / Part P of Building Regulations. Newnes, 2007.

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41

Agency, Highways. Design manual for roads and Bridges : Vol. 3 : Highway structures : inspection and maintenance, Section 2 : Maintenance, Part 2: Maintenance painting of Steelwork. Stationery Office, The, 2005.

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42

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 2 : Maintenance, Part 4: Conservation of Highway Structures. Stationery Office, The, 2020.

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43

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 2 : Maintenance, Part 1: Identification Marking of Highway Structures. Stationery Office, The, 2020.

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44

England, Highways. Design Manual for Roads and Bridges : Vol. 0 : Introduction and General Requirements, Section 2 : General Guidance, Part 7: Asset Delivery Asset Inspection Requirements. Stationery Office, The, 2020.

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45

England, Highways. Design Manual for Roads and Bridges : Vol. 0 : Introduction and General Requirements, Section 2 : General Guidance, Part 7: Asset Delivery Asset Inspection Requirements. Stationery Office, The, 2019.

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46

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 4 : Assessment, Part 3: Assessment of Bridges and Structures. Stationery Office, The, 2019.

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47

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 4 : Assessment, Part 8: Load Testing for Bridge Assessment. Stationery Office, The, 2019.

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48

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher y Sarah Gibbings, eds. Audits and inspections. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0024.

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Resumen
Audits and inspections are a vital and well recognised part of the clinical trial process. The requirement for quality data is recognised by everyone who works in clinical research. The ability to maintain accuracy and quality throughout a clinical trial is a dynamic process which involves both ongoing quality control (QC) steps and systematic and independent quality assurance (QA). This chapter starts by outlining the comparison between QC and QA and how these important processes form part of a Quality Management System (QMS) for an organisation. Additionally, we cannot begin to start discussing aspects of quality in clinical research without thinking about Good Clinical Practice (GCP) and this is frequently referenced throughout the chapter. Establishing a QA Unit, especially in the healthcare environment can be daunting. There always seems to be so many priorities and there are often pressures from within the organisation or from other teams for your help and support. It is important to allocate resources carefully to ensure the QA Unit is effective. By having an effective Quality Management System and a QA programme of effectual audits means that a range of possible risks may be prevented. Study-specific audits looking particularly at site audits are discussed as well as a systems based approach which is more common in larger QA Units. The audit process is reviewed in detail for both internal and external audits. Finally, inspection preparation, the inspection process and a detailed comparison of EMA, FDA and MHRA regulations used by inspectors is presented.
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49

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 2 : Maintenance, Part 5: Management of Post-Tensioned Concrete Bridges. Stationery Office, The, 2020.

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50

England, Highways. Design Manual for Roads and Bridges : Vol. 3 : Highways Structures : Inspection and Maintenance, Section 3 : Repair, Part 4: Management of Corrugated Steel Buried Structures. Stationery Office, The, 2020.

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