Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 21
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21Version 1.8 changes:
Header – Division of Field Science changed to Office of Regulatory Science
2.10 – removed Division of Investigations and Division of Field Science
Version 1.9 changes:
Throughout document – sample custodian changed to Sample Custodian
2.1 – revised section to include reference to LIMS
2.1.1 – added “or LIMS” to section
2.1.2 – added LIMS definition and “orLIMS” to other definitions as applicable
2.2.3 – added “or LIMS’ to second bullet of second paragraph
2.3. added “or LIMS” to section
2.4.1 – added “change of custody” to first paragraph & “or LIMS” to section
2.5.1 – added “or LIMS” to first paragraph & “change of custodianship” to second parag.
2.5.1.2 – added “or LIMS”
2.5.2 - added “or LIMS”
2.5.2.2 - added “or LIMS”
2.6.2 – added “or electronic form” to first & second bullet and “or LIMS” to first bullet
2.7.1 - added “or LIMS”
2.7.2 – added “or electronic form”
2.8 - added “or LIMS”
nd
rd
th
2.8.2.2 – added “or web application” to 2
paragraph and “or LIMS record” to 3
& 4
paragraph
2.8.3 - added “or LIMS”
2.9.1 - added “or LIMS”
2.9.2 – added “or LIMS record” to first paragraph
2.10 – added FACTS Manual and LIMS User’s Manual
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 21 of 21
This document is uncontrolled when printed: 6/4/2014
For the most current and official copy, check the Internet at
http://
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