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All Customers
| Where to obtain a copy |
|---|
Knowledge base articles about upgrades and validation | Software Upgrades and Validation |
Release notes | In the validation package |
Training on new features in each release | New Release Differences section of the training website |
Grand Avenue Software Quality Manual | Available on request from Grand Avenue customer support |
ISO 13485 and 21 CFR 820 Requirements Traceability Matrix | Available on request from Grand Avenue customer support |
21 CFR Part 11 Certificate of Compliance and Requirements Traceability Matrix | In the validation package |
Master License Agreement with Grand Avenue Software (Supplier Quality Agreement) | Available on request from Grand Avenue customer support |
Validation Package
At every release, Grand Avenue produces a validation package that is available to all customers at no additional charge. The validation package contains objective evidence of successful completion of the automated testing performed by Grand Avenue, which includes over 23,000 low-level functional tests and over 1,300 acceptance tests. The validation package also includes documentation of manual testing performed to validate aspects of the software that are not covered by automated tests.
Click to see a summary of the Grand Avenue 16.3 Validation Package contents.
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 16.3 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 16.3 Acceptance Test Results.xlsx | Pass/fail results of running automated acceptance tests on the release build. Pass: 1384 tests Fail: 0 tests |
GAS 16.3 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 16.3 New Release Differences.pptx | Training presentation showning only the differences between GAS 16.2 and 16.3. |
GAS 16.3 Release Checklist.docx | Checklist of tasks performed to prepare the final software build for release to customers. All steps completed and initialed. |
GAS 16.3 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 16.3 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 16.3 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. |
Click to see a summary of the Grand Avenue 16.2 Validation Package contents.
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. |
Click to see a summary of the Grand Avenue 16.1 Validation Package contents.
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. |
Click to see a summary of the Grand Avenue 16.0 Validation Package contents.
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. |
Click to see a summary of the Grand Avenue 15.6 Validation Package contents.
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. |
Hosted Installations Only
Grand Avenue Hosting Environment Documentation | Where to obtain a copy |
|---|
Equivalency between GAS Production and Training/Upgrade Environments | Available on request from Grand Avenue Support |
Grand Avenue Hosting Server Backup Policy | Available on request from Grand Avenue Support |