Summary of Upgrade and Validation Documentation

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: 1301 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 16.1 and 16.2.

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: 22,116 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.

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 16.1 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 16.1 Acceptance Test Results.xlsx

Pass/fail results of running automated acceptance tests on the release build.

Pass: 1252 tests   Fail: 0 tests

GAS 16.1 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 16.1 Release Checklist.docx

Checklist of tasks performed to prepare the final software build for release to customers.

All steps completed and initialed.

GAS 16.1 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 16.1 Unit Test Results.xlsx

Pass/Fail results of running automated unit tests on the released version of the software.

Pass: 21,548 tests   Fail: 0 tests

GAS 16.1 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.

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 16.0 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 16.0 Acceptance Test Results.xlsx

Pass/fail results of running automated acceptance tests on the release build.

Pass: 1246 tests   Fail: 0 tests

GAS 16.0 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 16.0 Release Checklist.docx

Checklist of tasks performed to prepare the final software build for release to customers.

All steps completed and initialed.

GAS 16.0 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 16.0 Unit Test Results.xlsx

Pass/Fail results of running automated unit tests on the released version of the software.

Pass: 21,746 tests   Fail: 0 tests

GAS 16.0 New Release Differences.pptx

An overview presentation of the major changes from the previous version.

GAS 16.0 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.

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 15.6 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 15.6 Acceptance Test Results.xlsx

Pass/fail results of running automated acceptance tests on the release build.

Pass: 1255 tests   Fail: 0 tests

GAS 15.6 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 15.6 Release Checklist.docx

Checklist of tasks performed to prepare the final software build for release to customers.

All steps completed and initialed.

GAS 15.6 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 15.6 Unit Test Results.xlsx

Pass/Fail results of running automated unit tests on the released version of the software.

Pass: 21,606 tests   Fail: 0 tests

GAS 15.6 New Release Differences.pptx

An overview presentation of the major changes from the previous version.

GAS 15.6 Validation Letter.pdf

Letter signed by Grand Avenue CEO 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.