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 for all master data generated from the computer for Raw materials 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 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 in charge.
• Take a final printout & stamp it “APPROVED” & get a sign of in-charge. Preserve it as an approved copy.
• Allocate the password to the file and inform to section in charge, dept head, and the IT dept. on finalization of specifications.
• On receipt of the raw material for analysis, take print of blank COA of above specification and issue to concerned chemist duly authorised by section incharge with help of allocated password.

For the Finished product section

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

Abbreviations

IT: Information and Technology

QA: Quality Assurance

COA: Certificate of analysis

Revision History

Nil

NOTE: When a protocol is not available (In case of Loan license product & others) then on receipt of the Finish the product for analysis, the section in charge shall generate a blank printout from the computer and Shall issue it to the concerned chemist.

ALSO READ: ALCOA++: Data Integrity to the Next Level