Auto IQ/OQ ValidationUse STATLIA MATRIX’s automated IQ/OQ validation program to satisfy your regulatory requirements for your bioassay analysis software and detector interfaces.
Auto IQ/OQ Validation Offers Complete Software and Detector Testing
The STATLIA MATRIX Auto IQ/OQ Validation Package includes:
- Auto-executes in 15 minutes, then ready for signatures
- Complete 6 part, 149 page validation report plus supporting documents
- All computations and operations tested
- 11 page Validation Plan and Instructions
- 12 separate Test Scripts
- 24 Data Reduction settings
- 1478 User Requirements
- 1542 Test Cases
- Trace Matrix of User Requirements to Test Cases
- Validation test results summary
- Screen captures of each step
- Observed and expected results compared with Pass/Fail and date stamp
- All expected, observed, and difference reports retained for verification
- Separate validation package for each detector interface
Auto Executed Test Scripts Provide Screen Captures of the Execution Steps
- There are 12 separate test scripts with each step listed and numbered.
- The steps performed on each screen of the program are captured as the Observed screen and can be compared to the Expected screen.
- The validation program records and dates with a green Passed or red Failed the execution of each step.
Test Cases Identify Report, Table and Spreadsheet Cell For Easy Verification
- There are 1542 Test Cases testing every computation and operation performed by the program.
- Each Test Case is identified with the Test Script, Report, Table, Metric Name and report spreadsheet cell the metric is found in.
- The validation program compares each cell in the executed (Observed) reports to the matching cell in the Expected reports, and records a green Passed when the fields are the same or a red Failed if they are different.
- All Expected and Observed reports are saved with the Supporting Documents.
Trace Matrix Matches Each User Requirement with its Test Case
- Each User Requirement is matched to a corresponding Test Case(s) that tested the execution of that function.
- A Validation Summary records the number of Test Cases that Passed and that Failed in the 116 Test Case Groups that were executed in the validation.
- The report includes sections for reviewer observations and approval signatures for the Validation Plan and the final Validation Report.