| Comment Record |
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Commentor |
Mr. Wolfgang Winter |
Date/Time |
2001-12-21 09:09:20 |
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Organization |
Agilent Technologies Deutschland GmbH |
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Category |
Company |
| Comments for FDA General |
| Questions |
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1. General Comments
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Section 5.1
Original wording:
Other factors not specifically addressed...
Discussion:
The technical examples (scanner resolution, scalability, operating environment) are areas that are covered in the technical specifications of a manufacturer and have to be addressed during operational qualification and performance verification.
The trustworthiness and reliability of electronic records can be severely affected by other factors that are typically not covered by technical specifications and OQ/PV. For analytical systems and devices, this can be the case when a device is controlled from software package developed by a different manufacturer and where the communication protocol (drivers) are not public domain. The lack of a support agreement between the software vendor and the device manufacturer can affect the trustworthiness and reliability of the electronic records generated by the system.
Recommended wording:
add the following example:
- Devices controlled by software: The reliability of the communication between the device and the control software may be affected by the communication protocol implementation in terms of error detection, handshake communication and official support of the software developer by the device manufacturer.
Section 5.4.2
Original wording:
Structural testing....
Discussion:
The terms structural testing, white-box testing,black-box testing are not defined in the glossary.
The paragraph appears to indicate that structural testing (white-box testing) is limited to code and document inspections.
While the reviews are absolutely necessary for the software development team, they are not practical for the end-user of a large, complex software system.
However, this is only one piece of this test approach. In the literature, these tests are called structural test cases (e.g Hetzel) and systematically cover a system's logical structure. This knowledge is obtained by inspecting the source code. Ideally, these test cases are developed along with the code. Modern testing techniques allow performing white-box tests automatically through appropriate test engines once the so-called test harnesses (test interfaces and test beds) have been implemented by the software developer. This technique is particularly relevant for modern, object-oriented software products where internal data integrity can hardly be ensured through black-box testing alone. Test engines can be made available by software manufacturers to end-users to execute regression testing on the system.
Recommendation:
Replace the original paragraph on structural testing with the following statement
This testing usually includes inspection (or walk-throughs) of the program code and development documents, as well as executing tests that have been specifically designed based on the logical structure of the software code. The goal is to provide a high degree of assurance for the integrity of data even during normal operation and under boundary or error conditions.
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