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Overview:
The Purpose of Validation is to ensure that the data acquisition
system, "The Director" is installed properly and is
accurately collecting, analyzing, and reporting the results.
Towards that purpose a series of checks and tests have been
incorporated into this procedure. When tests are performed all
instruments used in conjunction with that test must have calibration
certificates traceable to NIST.
Each test must
be signed and dated by the performing individual as well as
the person witnessing the test.
Traditionally an in-house
department performed these services. However, the high standard
of maintenance required on increasingly complex products and
systems has proved difficult and expensive. As a result, more
and more companies are delegating their calibration and maintenance
to outside experts.
The Software
Validation Protocol is intended to verify the following:
- Hardware verification and serial number confirmation.
- Digital Signal Processor.
- The Brick.
- Magnetic Pickup.
- Cables and connectors appropriate for the specific installation.
- Computer make, model, serial number, processor type and speed.
- Monitor make, model, serial number, and size.
- Electrical power supplied to the system is properly grounded and has the correct polarity and neutral at the outlet.
- Transducer calibration sheets are current and available with the correct serial numbers.
- Calibration documentation for The Brick and DSP is current and available.
- Software version identification.
- System password and security features.
- File structure for product, batch and study is correct.
- The program identifies the correct machine.
- Correct identification of selected station tooling.
- Verification that the auto taring function removes an offset.
- The status bar displays the correct rotational speed.
- Verification that the following calculations are correct for the real time displays.
- Tooling force limits for each system of units.
- Tooling cross sectional area, perimeter area and fracture length is correct.
- Force and pressure values are correct for each display and for each system of units.
- Verify that the suggested force increments are correct for the compaction study.
- Verify that the correct stations are identified in the peak bar chart display.
- Verify that the software is correctly identifying the tooled stations.
- Verification that the reports agree with the real time displays during data collection.
- System recovery from intentional closing of the program during data collection.
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