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Software changes

The tutorials that follow contain instructions for using SpartanBuild Each tutorial gives instructions for a related group of tasks (install software change model display etc) Computer instructions are listed m the left hand column and comments are listed m the right hand column Please perform these instructions on your computer as you read along... [Pg.1258]

Proof testing using non hazardous chemicals after making software changes... [Pg.123]

With a host computer framework, the control package is all in the software. Changing the program can still be agonizing, but the program can be tested off-line. There is more flexibility in the computer system, which can be used for many other purposes, including on-line heat and weight balances. [Pg.180]

The SOPs on software change control and data change control must be written in a coordinated fashion to avoid conflicting requirements. [Pg.141]

Records the software change identification code or date, the tester s initials, the date and scope of testing, and a pass/fail judgment. [Pg.143]

Part of the software change SOP or the inclusive change control SOP... [Pg.143]

Written documentation of change control procedures must exist to provide a reference and guidance for management of the ongoing software change and maintenance process. All steps in this process should be explained or clarified, and the procedures should be available to all system users. [Pg.150]

For Y software changes, your SOP might specify testing the new feature and any modules or sections that interact with that change. [Pg.195]

Change Control System configuration changes hardware, firmware, and software change and its impacts. [Pg.807]

When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. [Pg.262]

All hardware and/or software changes must be made by a designated individual(s)... [Pg.263]

Merely as a result of software changes, the stroboscope method with our experimental setup afforded a time resolution of a few microseconds (Souvignier and Gerwert, 1992). [Pg.624]

There were no written standard operating procedures for, but not limited to, system validation, hardware and software change control, revalidation,... [FDA Warning Letter]... [Pg.54]

Software changes and upgrades must be conducted according to defined procedures and docnmented. [Pg.68]

Firm s change control procedure does not include software changes. [FDA 483, 2003]... [Pg.83]

Class A Software change must be completed, software replaced, or supplementary controls introduced (e.g., procedural control or additional technical control) before the system can be released. [Pg.221]

The version software change was not properly validated prior to its use. [FDA Warning Letter, 1999]... [Pg.294]

There were no written Standard Operating Procedures for hardware and software change control and software revision control. [FDA 2001]... [Pg.294]

Software changes Assess software updates for compatibility with the existing software with particular emphasis on any changes made. In terms of system or standard software products, there is normally a bug fix list and details of new, modified, and removed features. Supplier s documentation should include an analysis of the impacts of the patch on their system, and this should be used by the customer to assess the extent of testing required to validate the patch implementation. These documents should be assessed to determine the effects of the change and any appropriate testing performed and incorporated into a validation dossier. [Pg.536]

Software changes are carried out on a separate development system and are subject to the normal validation testing and documentation updates to the IPC application. Changes to hardware are assessed and tested for compatibility with the enviromnent and the system specification is updated to reflect the current installation. [Pg.616]

Is there a change control procedure to ensure that all hardware and software changes are properly documented 11.10(k)2... [Pg.872]

See other pages where Software changes is mentioned: [Pg.121]    [Pg.1055]    [Pg.1058]    [Pg.590]    [Pg.143]    [Pg.143]    [Pg.815]    [Pg.834]    [Pg.190]    [Pg.424]    [Pg.60]    [Pg.236]    [Pg.83]    [Pg.221]    [Pg.462]    [Pg.463]    [Pg.491]    [Pg.615]    [Pg.683]    [Pg.788]    [Pg.932]    [Pg.943]    [Pg.947]    [Pg.559]   
See also in sourсe #XX -- [ Pg.295 ]



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