1.0 DESIGN QUALIFICATION
1.1 Define the Biometric Technology Used. It’s Principle and Capturing System. E. g
1.2 Define the Extraction and Comparison Process
Specify how the system will extract the captured data and convert into mathematical Code /template for comparison purpose.
Specify the threshold value for the purpose of comparison.
1.3 Define Vendor Qualifications for Biometric System.
- Number of Biometric System installed.
- Types of the technology used.
- Type of post marketing feed back received by him.
1.4 Define Final Specifications and Acceptance Criteria agreed between Vendor and User.
- Technology to be used.
- Capturing device to be used.
- Extraction and Comparison system to be used.
- Threshold value for the match.
- Maximum Failure rate (False Rejection, False Acceptance) per day.
2.0 IQ FOR BIOMETRICS
2.1 Check the computer system where it will be installed.
- Check the drive.
- Check the space required.
- Check the ancillary softwares required on Computer.
- Check the power supply.
- Check the dust controls procedures used in the room where system is to be installed.
- Check whether the system meets the agreed specifications.
3.0 OPERATIONAL QUALIFICATION
3.1 Define the SOP for Biometrics.
3.2 Check the password, which may be required to activate the system.
After activation check if the system is ready to scan, extract and compare the specified biometric feature.
3.3 Check for operation manual, maintenance, and calibration manuals.
4.0 PERFORMANCE QUALIFICATION
Try excess to the computer system by exposing required biometric feature to the machine
Record the results as per follows
Specify the conditions of scanner plate during PQ ( It should be free from dust and smudges.
Specify integrity of biometric feature (The body part which is used by the system shall be intact. It shall not be cut, bruised, or damaged. For Example, if entire Finger is used, it shall not have cuts).
5.0 ACCEPTANCE CRITERIA
- Failure to activate the screen : Nil
- False Rejection : Nil
- False Acceptance : Nil
6.0 VALIDATION REPORT
- Describe the DQ, IQ, PQ, and OQ briefly.
- Describe the SOP followed for PQ
- Compare the results against the acceptance criteria.
- Conclude – System is satisfactory. System needs improvement and revalidation.
7.0 SOP’S for the Biometric System based on Finger Technology.
• Activate log on screen.
• Check the scanner plate.
• Clean it if there is smudging.
• Clean the left index finger, wipe it dry and expose the required area/ part to scanner plate.
• Wait for response.
• If allowed, proceed with you work.