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U.S. Department of Health and Human Services

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Volume III - 3.10 Document Change History

DFS Pyramid Logo

Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-03

VERSION NO.:2.0

Section 3 – Recording of Results – Analyst Worksheet

EFFECTIVE DATE:
03-25-04
REVISED: 05-02-14
Version
No.
Status
(I, R, C)
Date
Approved
Location of Change HistoryName & Title
AuthorApproving Official

1.3

R

03-23-05

Table of Contents - removed /704d Letters from 3.7
Table of Contents - added 3.9 Document History
Section 3.7, Title - removed /704d Letters

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1.4

R

12-06-06

3.3.2, Block 9. Labeling: - added term "set"; defined "label" and set in first paragraph;
added identification examples and assembly of labeling sets to last paragraph.
3.3.2 Block 10. Summary of Analysis: - moved second sentence from Container: to
first paragraph of Labeling:
3.9 Changed from Document History to Document/Change History

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1.5

R

08-15-08

3.4.2.2 Added f.

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1.6R02-02-10

Version 1.6 changes:

3.2.1 b. – corrected reference from 3.2.2.2 to 3.2.2.3

3.2.2.3 d. – corrected reference from 3.2.1 c. to 3.2.1 d.

3.2.5 – deleted reference to ORA Laboratory Manual, Volume V

3.5.3 – added “designee” to paragraph

3.6 – added reference to ORA-LAB.5.10, Section H.2.

Footer - updated

 

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 1.7 R07-20-10

3.3.3 Added "to complete the analysis, or reference to attachments, logbooks, or appropriate worksheets containing this information" to first paragraph.

3.5.1 and 3.8 Added "photocopies" as examples of attachments

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1.8R02-06-12

3.3.2 Block 7 – added “from the Collection Report: in last sentence

3.3.2 Labeling – revised second sentence in second paragraph

3.4 – Title changed to Types of Analysis

3.4.1 – heading changed to Types; added bullets on Screening, Confirmatory, and Determinative

3.5.3 – added last section on reporting results

3.8 – revised Class #5 definition

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1.9R01-29-13

Header-Division of Field Science changed to Office of Regulatory Science

3.4.2.2.c.-Division of Field Science changed to Office of Regulatory Science

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2.0R05-02-14Contents:  3.2.5 – added Laboratory Information System
Contents:  3.9 – changed to References
Contents:  3.10 – now Document Change History
3.1 – changed FACTS system to “web application, such as FACTS or LIMS”
3.2.1 – revised first paragraph
3.2.1 a. – added “Handwritten”
3.2.1 b. – added “or web application”
3.2.2.1 – added last sentence
3.2.2.3 – added “or web application”
3.2.2.3 c. – added “or electronically”
3.2.2.3 d. – added “or LIMS generated PDF file”
3.2.3 – revised second paragraph
3.2.5 – added references to LIMS
3.3.1 – added “or enters information into the web application”
3.3.2 – minor changes made to grammar
3.3.2 Block 6 – deleted District
3.3.2 Block 7 – added to last sentence
3.3.2 Block 9 – added to last sentence of first bullet on retaining original label
3.3.2 Block 10 Containers – added “or photo”
3.3.2 Block 10 Labeling – revised
3.3.2 Block 11 – added “or LIMS”
3.3.4 – added “handwritten” to first bullet
3.5.1 – added reference to LIMS at end of first paragraph & Attachments first bullet
3.5.2 – added reference to LIMS to Supervisor Review
3.5.3 – added reference to LIMS
3.8 – added reference to LIMS in definition of Lab Class 5
3.9 – added references
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