SOP for Method for Programme File Checks of Software of Instruments : Pharmaceutical Guidelines

SOP for Method for Programme File Checks of Software of Instruments

Standard operating procedure to check the programme files of the software related instruments, installed in quality control.

1.0 Objective

To define the method for programme file checks of software of instruments.

2.0 Scope

This procedure is applicable to software related instruments, installed in the quality control department.

3.0 Responsibility

3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive /Assistant Manager

4.0 Accountability

Head of the Department

5.0 Procedure

Frequency: Every two month
5.1 Switch ‘ON’ the mains.
5.2 Switch ‘ON’ the instruments.
5.3 Refer respective manual of instruments.
5.4 Follow all the instruction before taking any programme file of any instruments.
5.5 Perform programme file checks.
5.6 Take the print out and maintain the record as per Annexure-I.
5.7 In case any file found not O.K follow S.O.P.

6.0 Abbreviations

6.1 SOP - Standard Operating Procedure
Related: SOP for Backup/Restore Analytical Data in Electronic Form

ANNEXURE-I
QUALITY CONTROL LABORATORY
PROGRAMME FILE CHECKS FOR PERFORMANCE OF SOFTWARE

PERFORMANCE DATE

DATE OF LAST PERFORMANCE DONE
NEXT DUE FOR
PERFORMANCE



INSTRUMENT DETAILS
INSTRUMENT NAME

INSTRUMENT MAKE

INSTRUMENT
IDENTIFICATION NO.




OBSERVATION


1)  All programme files ____________________ ( OK/ Not OK)

     [Acceptance criteria  :- All files should be OK]

CONCLUSION
INSTRUMENT WORKING SATISFACTORY
INSTRUMENT NOT WORKING   SATISFACTORY
PERFOMED BY
CHECKED BY
NAME
SIGN.
DATE
NAME
SIGN.
DATE





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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