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Fusion AE Software Validation – Products and Services
S-Matrix Corporation provides complete documentation,
products, and support services for software validation of its Fusion AE
software package. S-Matrix can provide on-site software validation services or
on-site support for customer software validation. S-Matrix can also provide the
following Software Validation Documentation:
- Fusion AE Software Validation
Testing and Testing Scorecard – IQ, OQ, PQ.
Document Purpose
Describe and present S-Matrix
Corporation’s Final Release Testing Scorecard for Installation Qualification
(IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Testing
of the Fusion AE™ software, Version 8.6
Document Scope
• Identify and list the definitions, references, and tools utilized by S-Matrix Corporation’s Final Release and Customer Software Validation Testing.
• Specify the Testing Plans executed by S-Matrix Corporation as part of IQ, OQ, and PQ testing for Fusion AE.
• Present an example of S-Matrix Corporation’s IQ, OQ, and PQ Testing Scorecard for Fusion AE.
- S-Matrix Corporation Software
Quality Management System.
Document Purpose
Specifies and describes the
processes of S-Matrix Corporation’s Software Quality Management System.
Document Scope
• Identify and describe the S-Matrix Corporation’s Software Development Life Cycle Model processes, and systems for Task Management, Issue Management, Version Management, Release Management, and Recovery Management.
• Identify and describe the processes that must be implemented to complete a project.
• Identify and describe the primary results, requirements, organizational structure, policies, standards, and procedures of each process.
- Certificate of Software Validation – Fusion AE.
W
e assure that the software was developed using the Software Development Project
Life Cycle model outlined in the S-Matrix Software Qualification Management
System document (Rev 1.0 or higher).
We further assure that the software was tested and validated
according to the steps outlined in the Fusion AE Software Validation Testing
document (Rev 1.0 or higher). The product was found to meet the marketing and
functional requirements and release criteria as outlined in the document at the
time of shipment.
- Certificate of Software Validation –
MS Excel Scorecard Workbook.
W
e assure that the Microsoft® Excel Workbooks used in Fusion AE Software
Validation Testing only use Excel’s intrinsic “IF” and “SUM” functions, and
that no Macro routines or other functions are used in the Excel operations
associated with “Pass/Fail” test results generation within the spreadsheets and
workbooks provided as part of the Fusion AE® Software Validation Testing file
suite.
We further assure that the Microsoft® Excel Workbooks
used in Fusion AE Software Validation Testing contain the proper write
protection, that each spreadsheet in each workbook contains an identical
implementation of the “IF” and “SUM” functions associated with “Pass/Fail” test
results generation, and that these spreadsheets have been rigorously tested and
internally validated by S-Matrix.
- Certificate Supporting Documentation.
To support the Fusion AE and Microsoft Excel Scorecard Workbook
certificates for GLP and cGMP requirements of the user of this product, we will
make the following documents available to customers, an authorized governmental
or regulatory agency for inspection at S-Matrix Corporation, Eureka,
California:
· Marketing Requirements Definition
· Functional Specification
· S-Matrix Software Qualification Management System
· Fusion AE Software Validation Testing
· Test Summary Reports
· Source Code Documentation
· Hardware Testing Configurations
S-Matrix Corporation will maintain this documentation
on-site and will require a non-disclosure agreement to be provided by those
wanting access to the information.
Customer Software Validation Package
S-Matrix can also provide a complete Customer Software
Validation Package for Fusion AE that includes the following documents:
- Fusion AE Software Validation Testing.
Document Purpose
Describes the types of tests and
specifies the IQ, OQ, and PQ Testing Plans for Fusion AE Version 8.6.
Document Scope
• Specify all the test plans executed in the full software validation testing of Fusion AE Version 8.6.
• Identify and list the definitions, references, and tools utilized by S-Matrix Corporation’s Validation Testing.
- Fusion AE Software Testing File Suite.
The Fusion AE Software Validation
Package comes on CD. The CD contains the Fusion AE Software Validation
Testing document in PDF format. The CD also contains every testing data file
and data set required for execution of each testing plan, including
pre-programmed MS Excel Workbook files for automated verification of Pass /
Fail for each test.
- Certificate of Software Validation – Fusion AE (see above).
- Certificate of Software Validation – MS Excel Scorecard Workbook (see above).
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Validation
