Software upgrades

Sodium imaging is relatively time consuming and cannot be performed on standard clinical scanners without specialized hardware and software upgrades. Nevertheless, the unique physiologic information provided by sodium imaging may make this technique an important tool in acute stroke imaging in years to come. 

Ultrasound imaging is mostly two-dimensional. Real-time three-dimensional systems that give a field of view wider than a thin sHce at a time are still quite rare and expensive. Quasi-3D systems based on manual lateral translation of the probe are gradually becoming available as software upgrades for existing equipment. 

Examples of such activities include installation of circuit boards that might hold new versions of firmware, software, addition of new network elements, software upgrades, fixes, and service packs. ... 

SOPs for software upgrades, bug fixes, and patches must be approved before such changes can be made. 

With every software upgrade, either of the application or an operating system, the validity of previously recorded data hies should also be checked. This can be achieved by comparing the data derived from a legacy system with the data derived from the system upgrade. 

There was no validation data to show that the data acqnisition system gave accurate and reliable resnlts after the hrm made several hardware and software upgrades. [FDA 483] The firm did not keep track of changes to operating system. [FDA 483]... 

Extent of design changes — cumulative effect of changes to the computer system (including software upgrades) made since the last (re)validation exercise... 

If the user purchases a software upgrade, the supplier should supply documentation with a description of the change, a statement that the upgrade has been validated by the supplier during development. The supplier should provide information on ... 

The conversion utilities must be tested to confirm that they continue to operate as expected after every software upgrade. 

Implicit with IPC systems is the rate of change of the available hardware and software. Upgrade paths must be controlled to ensure the IPC is maintainable into the future. 

Do you have procedures to control hardware and software upgrades ... 

Evolution of standard client Distribution of software Upgrades... 

D. EEPROM (Electronically Erasable PROM) is even more sophisticated than EPROM in that it can be erased and reprogrammed using software tools. This makes it an exceptional choice for BIOS chips. Software upgrade utilities are much easier to implement (and have less chance of error) than replacing an entire chip. 

The Upgrade Report summarises potential hardware and software upgrade issues. 

CAP) inspection and accreditation checklists for laboratory computer software focus on documentation of practices that ensure the safe and reliable operation of the system, such as regular backup of data, validation of system function following software upgrades, and regular testing of the correctness of transmitted or printed laboratory results. 

Incorrect interpretation of the DICOM header values or hugs in the viewing software could also introduce prohlems. Radiologists should be aware of this fact and always critically check the quality of their images after setup or after software upgrades. 

One strategy that strengthens the acquisition process is the conditions-of-sale document. This multifaceted document integrates equipment specifications, performance, installation requirements, and follow-up services. The conditions-of-sale document ensures that negotiations are completed before a purchase order is delivered and each participant is in agreement about the product to be delivered. As a document of compliance, the conditions-of-sale document specifies the codes and standards having jurisdiction over that equipment. This may include provisions for future modification ofthe equipment, compliance with standards under development, compliance with national codes, and provision for software upgrades. 

NOTE 1 A common problem with firmware and utility software upgrades is compatibility within existing integrated systems comprised of other hardware and software products. However for fixed programming language devices, compatibility is limited to the communication interface (example HART communication). 

A schematic diagram summarizing failures that led to the gasoline pipeline rupture and fire in Whatcom Faiis Park. This accident was due to a combination of pipeline damage (caused by poorly supervised excavation work around the pipeline several years earlier), inadequate non-destructive inspections of the pipeline, a wrongly specified pressure relief valve, inadequate investigation of valve control problems, and uncontrolled software upgrades ( SCADA" was the computer-based control system). 

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