PROCESS FLOW:

•  Product is registered by defining the stages.
•  Unique Product is generated by the system after approval.
•  All BRM Requests are initiated and submitted by uploading the documents
•  BRM Request is Reviewed/Approved by various people based on requirement defined in BRM Approval Work Flow (like HOD Review, QA Coordinator Review and QA Head Approval).
•  Unique BRM No. is generated automatically after approval.
•  BRM Publish Requests are submitted by entering the effective Date.
• BRM Publish Request is Reviewed/Approved by various people based on requirement defined in BRM Publish Approval Work Flow (like HOD Review, QA Coordinator Review and QA Head Approval).
• BRM is Effective based on the Effective date after Publish Approval.
• Approved BRM are requested for BRM Issuance Request by the Manufacturer by requesting the Issue Batch Size
• BRM Issuance Request is initiated, Reviewed/Approved based on the work Flow.
• BRM is printed by the Document Controller or Production In-charge based on the Requirement by issuing automatic Unique batch Number for Issuance with auto update of expiry Date.
• Printed Documents are Issued and Received.
• BRM Issuance Reprint and Batch Size Correction Can be done.
• Received BRM Issuance Requests are requested for BRM Return by uploading the document.
• BRM Return Request is Reviewed/Approved by various people based on requirement defined in BRM Return Approval Work Flow (like HOD Review, QA Coordinator Review and QA Head Approval).
• BRM Document is Retrieved by the Document Controller

CHALLENGES:

• As the documents are physical and stored physically, there are high chances of losing them.
• In Manual System May the Manufacturer has the latest Approved BRM which effective
• No auto alerts/reminders.
• BRM issuance, print tracking, Retrieval of the issued document are major challenges in manual system.
• Time Consuming for Review and Approval Process and Unique number generation.

BENEFITS:

• Reduce Time Consuming for Review and Approval Process and Unique number generation
• Increase the productivity and decrease the effort required on each product and improves efficiency.
• It is easy to view the Master, Obsolete, Terminated BMR.
• The latest Effective BRM is reflected at Manufacturer.