SOP for Control of Master Data Generation by Computer System

OBJECTIVE

To have better control over the master data generation system.

SCOPE

This procedure is applicable to all master data generated from the computer for Raw material and Finished product.

RESPONSIBILITY

Doing: Technical Assistant

Checking: Executive/Manager

ACCOUNTABILITY

Head of the Department

PROCEDURE

For the Raw Material Section

• On receipt of the control copy of the raw material specification from QA, enter the respective specification in the computer as per the system available.
• Take out the print of the specification entered and get it checked by the section incharge.
• Take the final printout & stamped it “APPROVED” & get sign of incharge. Preserve it as an approved copy.
• Allocate the password to the file and inform to section incharge, dept head and the IT department on finalization of the specification.
• On receipt of the raw material for analysis, take a print of the blank COA of above specification and issue to the concerned chemist duly authorised by the section incharge with the help of the allocated password.

For the Finished product section

• On receipt of the control copy of the finished product material specification from QA, enter the respective specification in the computer as per the system available.
• Take printout of the specification entered and get it checked by the section in charge.
• Allocate the password to file and inform the section in charge, dept. head, and IT dept. on finalisation of specification.
• After release of the product, enter the results in the computer for COA format and print the same.
• Send the testing data sheet along with the COA to the section incharge for his signature.

ABBREVIATIONS

IT: Information and Technology

QA: Quality Assurance

COA: Certificate of analysis

NOTE: When the protocol is not available (In case of licensed products & others) then on receipt of the finish product for analysis, section incharge shall generate a blank print out from the computer and shall issue to concerned chemist.

ANNEXURE

Nil

REVISION HISTORY

Nil

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