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Table 194 FDA Warning Letters for Cleanrooms Extracted from Warning Letter WL 320-01-07 (January 11, 2001), Sweden: The alarm system that communicates, records, and controls alarms such as air balance and temperatures for production, warehouse and testing areas lacked the following: Documentation regarding functionality design and layout diagrams was found to be obsolete Validation documentation did not address signal lines between detection devices and computer Various documentation control de ciencies were reported, such as review, approval, and maintenance of records Extracted from Warning Letter WL 320-01-08 (January 11, 2001), Sweden: 2 The [named site] local computer systems lacked adequate validation and/or documentation controls For example: a The [] computer control alarm system that monitors the air handling units temperature, humidity and air ow/pressure The [] water system, and the temperature of various freezers and refrigerators, lacked the following: Documentation demonstrating an adequately validated system.



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For example: System description Functional tests of systems capability of simultaneously monitoring normal operations and/or assessing alarm conditions Description and de nition of utility and equipment alarm settings Exact number of monitoring and/or controlling devices and equipment monitored Evaluation demonstrating accurate printed information Adequate handling of records generated, with inaccurate time frames dating back 16 years for the mainframe computer clock and three years for the local workstation computer clock due to Y2K compliance related issues Appropriate procedures to ensure that records are included with validation documentation, maintained, and updated when changes were made b The [] alarm system that communicates, records, and controls alarms related to air balance and temperatures for the production, warehouse and testing areas, storage rooms, and coolers lacked the following: Change control documentation approving change in the software.

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Microsoft developed Microsoft Active Accessibility (MSAA) to improve the connection between assistive technology, such as software and Braille readers, and the Windows-based operating systems. MSAA standards help software developers create products for those with hearing, motion, or sight disabilities. MSAA also improves the communication between accessibility software and other Windows applications. Macromedia built MSAA technologies into Flash Player 6 and higher to enable screen readers that also support this technology. As such, these screen readers can access the Flash content in web sites. MSAA is considered a basic requisite when working with screen readers in the Windows environment. Macromedia s adoption of MSAA signals a new era of Flash development where software developers can adhere to an already established standard in assistive software technology.

In addition, there was no quali cation [] documentation for this change Validation documentation failed to include complete and updated system design documentation, and complete wiring/network diagrams to identify all computers and devices connected to the [] system Extracted from FDA Warning Letter 05-ATL-21 (August 11, 2005) United States of America: 2 Your rm failed to establish and maintain procedures to adequately control environmental conditions which could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 82070(c) [FDA 483, Item 4] You have failed to establish formal parameters for temperature, humidity, and pressure A review of Filling Room temperature records revealed several instances where the temperature range limits (on the form) were exceeded ..

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Extracted from FDA Warning Letter 01-ATL-73 (August 2001), United States of America: You have failed to validate the HVAC system used to control temperature and relative humidity in your manufacturing and warehouse areas No formal speci cations for temperature or humidity have been established for these areas You were noted to have portable chart recorders for monitoring of temperature and humidity in Suites 1 and 2 and one recorder was noted in the warehouse A wide range of temperatures and humidity was noted in our review of the data from the monitored areas The results exceeded your proposed speci cations shown to Investigator McCarver in your draft SOP E073 These proposed ranges would appear to be excessive particularly since you currently manufacture at least one product that has exhibited sensitivity to humidity..

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