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