1.0 Define the System
1.1 Describe the purpose.
- Analytical Use.
- Inventory / Store.
- Archives / Records.
- Management Information.
1.2 List of all Hardware.
1.1 List all Softwares.
1.4 List all Operational Parameters.
1.5 Define Requirements to Operator.
1.6 Define Security Requirements.
- Hardware Lock
- Password Access.
- Biometric.
- Hardware Lock + Password Access.
1.7 Check following parameters concerning to DQ
- Purchase Order.
- Certificates and specifications for Vendor.
- Communications between internal users and Vendors.
- Users Manual.
- Maintenance, Calibration, and testing guidelines.
- All Drawings.
- List of Spares Supplied.
1.8 Check following parameters concerning OQ.
- Date of Installation.
- Installation Report.
- Place of Installation.
- Power Supply.
- Safety aspects.
- Calibration Details.
- Functionability of all switches and ancillary devices such as Printer, Modem, LAN, FDD, ZDD.
1.9 Verify following matter concerning PQ
- Security System.
- Operator Qualification.
- Functioning of each module and functioning of the total system over anticipated operating range.
VALIDATION REPORT
Prepare Validation Report stating Acceptance Criteria and Observations.
CONCLUSIONS
- System was valid during its past use.
- System was not valid during its past use and performance may have errors.
- System was not valid and needs improvement.
- System has become outdated and may be dissolved.
1.5 Define Requirements to Operator.
1.6 Define Security Requirements.
- Hardware Lock
- Password Access.
- Biometric.
- Hardware Lock + Password Access.
1.7 Check following parameters concerning to DQ
- Purchase Order.
- Certificates and specifications for Vendor.
- Communications between internal users and Vendors.
- Users Manual.
- Maintenance, Calibration, and testing guidelines.
- All Drawings.
- List of Spares Supplied.
1.8 Check following parameters concerning OQ.
- Date of Installation.
- Installation Report.
- Place of Installation.
- Power Supply.
- Safety aspects.
- Calibration Details.
- Functionability of all switches and ancillary devices such as Printer, Modem, LAN, FDD, ZDD.
1.9 Verify following matter concerning PQ
- Security System.
- Operator Qualification.
- Functioning of each module and functioning of the total system over anticipated operating range.
VALIDATION REPORT
Prepare Validation Report stating Acceptance Criteria and Observations.
CONCLUSIONS
- System was valid during its past use.
- System was not valid during its past use and performance may have errors.
- System was not valid and needs improvement.
- System has become outdated and may be dissolved.
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