Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-021.00 Effective date: mm/dd/yyyy
Approved by:
• Any deviation
• Comments
• Performed by/veriied by
40.3.3 S
tandard
o
Perating
P
rocedureS
The following drafted procedures should be available at the time of operational qualification:
• Operation
• Cleaning
• Maintenance
• Calibration (if required)
• Training
• Other SOP (if applicable)
• Conclusion
• Any deviation
• Comments
• Performed by/veriied by
40.3.4 t
raining
Identify the names of the staff for training on the following at the time of operational
qualification:
• Operation
• Cleaning
• Maintenance
• Calibration (if required)
• Other (if applicable)
• Conclusion
• Any deviation
• Comments
• Performed by/veriied by
40.3.5 S
oftware
/h
ardware
(a
utomated
P
roceSS
c
ontrolS
)
• Software/hardware structural testing (optional)
• Software/hardware validation reports/certiicate
• Manufacturer audit reports
• Factory acceptance criteria reports
• Conclusion
• Any deviation
• Comments
• Performed by/veriied by
The above checks may be amended as applicable or other checks may be added. All documents
shall be verified.
Search WWH ::
Custom Search