Scribd
Upload
110 views1 page

Pace Model

The document outlines the roles and responsibilities for various individuals in preparing, reviewing, approving, and executing batch records. The Validation SPOC is responsible for revising and preparing batch records, which are then reviewed and approved by the Validation SPOC, line leader of QA, and operation team. The batch document controller and QA are responsible for issuing the batch records, while shift leaders, equipment owners and machine operators record data during execution.

Uploaded by

prakash
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
110 views1 page

Pace Model

The document outlines the roles and responsibilities for various individuals in preparing, reviewing, approving, and executing batch records. The Validation SPOC is responsible for revising and preparing batch records, which are then reviewed and approved by the Validation SPOC, line leader of QA, and operation team. The batch document controller and QA are responsible for issuing the batch records, while shift leaders, equipment owners and machine operators record data during execution.

Uploaded by

prakash
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 1

Business Use

PROCESS OWNER APPROVER CONTRIBUTOR EXECUTOR

Validation SPOC shall be responsible Validation SPOC, is responsible for Validation SPOC, is responsible for Batch document controller, QA is
for revising/ preparing the batch review owner assessment and preparing & revising the existing responsible for issuance of batch
records owner approval batch records records.
Line leader, QA & Line leader, line leader of QA & Operation team Shift leaders, equipment owners,
operation team are responsible for are responsible for technical review machine operators are responsible
technical reviewing and approving and approval for online recording the data
the batch records QA head, final approval of the batch batch record reviewers of QA &
QA Head , final approval of the records shall be done QA Head Operation is responsible for
batch records shall be done QA reviewing the executed batch record
Head Line leaders are responsible for
checking the final dispatch quantity
and batch release in sap system.
PACE MODEL OF BATCH RECORD HANDOVER

You might also like