Auto IQ/OQ Validation

Use 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.