File Name | Description |
21 CFR Part 11 Certificate of Compliance and Requirements Traceability Matrix.docx | A clause-by-clause description of how Grand Avenue complies with the applicable requirements of 21 CFR Part 11. |
GAS 16.2 Acceptance Criteria Report.xlsx | Excel workbook containing a worksheet with the full list of acceptance criteria for this release, and separate worksheets for the specific criteria that were added, revised or removed in each release. |
GAS 16.2 Acceptance Test Results.xlsx | Pass/fail results of running automated acceptance tests on the release build. Pass: 1384 tests Fail: 0 tests |
GAS 16.2 Manual Validation Checklists.pdf | Checklists of manual testing performed to validate aspects of the software (e.g., the user interface) that are not covered by automated tests. All tests passed. |
GAS 16.2 New Release Differences.pptx | Training presentation showning only the differences between GAS 16.2 and 16.3. |
GAS 16.2 Release Checklist.docx | Checklist of tasks performed to prepare the final software build for release to customers. All steps completed and initialed. |
GAS 16.2 Release Notes in Excel Format.xlsx | Release notes, formatted specifically for assessing upgrade impacts. In addition to descriptions of the software changes, this file also includes detail about each change’s applicability and whether it introduces new configuration options or requires migration of existing data. |
GAS 16.2 Unit Test Results.xlsx | Pass/Fail results of running automated unit tests on the released version of the software. Pass: 23,211 tests Fail: 0 tests |
GAS 16.2 Validation Letter.pdf | Letter signed by Grand Avenue executive stating that Grand Avenue’s validation processes have been followed for this release. |
Grand Avenue Customer Requirement Lifecycle Overview.pptx | Slide presentation that describes Grand Avenue’s customer requirement lifecycle and explains the development process that generates all the documentation in the validation package. |