Date and Time Format SOP
1.0
PURPOSE:
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1.1. To lay down a
procedure for entering date and time in documents, in same format.
2.0 SCOPE:
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2.1. This procedure
is applicable to all the operational documents at _____ Pharmaceuticals
3.0 RESPONSIBILITY:
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3.1. All departments Head
3.2. QA Officer
3.3. QA Manager
4.0 PROCEDURE:
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4.1. Entry of date for all the documents shall
be as follows:
4.1.1. First and second character shall represent
the date “DD”.
4.1.2. The third character shall be dash “-”.
4.1.3. Fourth and fifth characters shall represent
the month “MM”.
4.1.4. The sixth character shall be dash “-”.
4.1.5. Seventh and eight characters shall represent
the year “YY”.
4.1.6. Date format notation DD-MM-YY. Example:
28-08-18, 28 shall represent date, 08 shall represent the month and 18 shall
represent the last two digits of the year.
4.1.7. When documents are system generated, then
Date Format “MM-DD-YY” is also acceptable.
4.2. Time Entry in all written procedures shall
be as follows:
4.2.1. Twenty four hour clock shall be used for
recording the time in all the written procedures e.g. if we want to write 01:40
PM instead of that we shall write 13:40.
5.0
REVIEW FREQUENCY:
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SOP
will be reviewed at least Annually.
EVIDENCES OF RECORDS & REFERENCES
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Documents of all department
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FORMAL KPIs (Key Performance Indicators)
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All documents with date and time format as per SOP
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GENERAL
RISKS
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CONTROL MEASURES
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CUSTODIAN
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Risks
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Impact
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Time has written as in 12 hours format
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Misunderstanding of the time leads to wrong entries etc
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Follow
SOP while entering date and time in any document
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All
personnel engaged with documents
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