Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-030.00 Effective date: mm/dd/yyyy
Approved by:
49.1 PurPose
To provide a written procedure for documenting key performances, milestones, achievements, inci-
dents, accomplishments, problems, and major deviations that took place in various departments of
the ABC Pharmaceutical Company.
49.2 resPonsibilities
1. The QA officer will be responsible to initiate the report and send a request to the managers/
directors of all the departments to provide the key performance indicators (KPIs) of the
current month.
2. Managers/directors of the corresponding departments will be responsible to send the KPIs
of their respective departments to the QA officer by the 5th day of each month.
3. All departmental directors are responsible for system compliance.
49.3 Procedure
Each departmental manager/director will fill out the template given in the following pages accord-
ing to the requirements of their respective department and will forward it to the QA officer no later
than the 5th day of each month.
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