Electronic Data File Numbering System

I.    PURPOSE :

       To have a procedure for the electronic data file numbering system.

II.    SCOPE:

    To allot numbers for electronic data files generated during analysis in quality control department .

III.    RESPONSIBILITY:
        It is the responsibility of  Quality Control personnel to follow this SOP.            

IV.    DOCUMENT REFERENCE :
        SOP    :  Nil.
        Form    :  Nil.
V     PROCEDURE :
1.0  The chromatograms shall be acquired and stored with the combination of system identification number and data file number as below.    

Data file No:
Ex:    :  xxxxx
         :  Instrument identification 
04     :  Year code for 2004 (05for 2005, 06 for 2006 and so on)
                     07     :  Month code for July (01 for January, 02 for February …12 for December).
25    :   Date on which analysis started
001         :      Data file serial number for that date.

2.0    The chromatograms shall be filed along with analytical reports of respective products batch wise. In case more than one batch is analyzed at a time then system suitability chromatograms shall be filed with first batch analyzed. Corresponding set of chromatograms filed along with batch wise test reports should indicate the traceability of system suitability chromatograms. 

3.0    Data file number should be entered in equipment logbook. All chromatograms & data of HPLC, GC shall be stored in the electronic form including validation data.

4.0    After storage of electronic data from hard disk to CD, authorized QC person shall delete the same data from the hard disk.

5.0    Data numbering format for each system is given as annexure. 

Electronic, annexure, chromatograms, combination