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Food and Drug Administration ORA-LAB.5.5.1
Page 1 of 6
Title: Effective Date:
INSTRUMENT AND EQUIPMENT DOCUMENTATION AND 10-01-03
RECORDS Revised: 05/02/14
For the most current and official copy, check the Internet at
http://www.fda.gov/ora/science_ref/lm/default.htm
6. A. Overview
Procedure
1. The instrument or equipment records are compiled and required
information maintained in a readily accessible manner. There is
no requirement that the records be kept in a bound notebook or
binder. Records may be kept electronically. For electronic
records, local work instructions state where these records are
located, how they can be accessed, and authorized personnel.
2. The records are kept in a secure, accessible place in the
laboratory.
3. The records for similar instruments may be kept together if they
are clearly identified and separated. For example, multiple
balances may share a single location.
4. The records are maintained for a period determined in each
laboratorys record and data management procedure.
B. Logbook Sections
FDA number;
______________________________________________________________________________________
For the most current and official copy, check the Internet at
http://www.fda.gov/ora/science_ref/lm/default.htm
2. Operating Instructions
assessment..
______________________________________________________________________________________
For the most current and official copy, check the Internet at
http://www.fda.gov/ora/science_ref/lm/default.htm
Test method,
Test data,
Certificate of conformance.
C. Maintenance
initials of the analyst, and the date the problem was observed,
______________________________________________________________________________________
For the most current and official copy, check the Internet at
http://www.fda.gov/ora/science_ref/lm/default.htm
E. Non-Conformances
G. Manufacturer's Instructions
7.
Definitions None
______________________________________________________________________________________
For the most current and official copy, check the Internet at
http://www.fda.gov/ora/science_ref/lm/default.htm
Document History
Version Status Date Location of Name & Title
No. (I, R, C) Approved Change History Author Approving Official
1.2 R 11/16/05 In Document LMEB LMEB
1.3 R 05/08/14 In Document LMEB LMEB
______________________________________________________________________________________
For the most current and official copy, check the Internet at
http://www.fda.gov/ora/science_ref/lm/default.htm