• With the testo Saveris data logger system you can enjoy professional, automated humidity and temperature monitoring. All measurement data is stored in a database.
• The testo Saveris CFR Software basic package with testo Saveris Web Access includes validatable software. This fulfils the requirements of the FDA’s 21 CFR Part 11. Up to five users can view, examine and analyze measurement data from the testo Saveris data logger system on their PC. Thanks to testo Saveris Web Access, these users can also conveniently access the measurement data via their browser – using any PC, smartphone or tablet.
• Validatable software fulfils the requirements of the FDA’s 21 CFR Part 11
The testo Saveris CFR Software fulfils the requirements of the FDA’s 21 CFR Part 11 and is therefore validatable. This is confirmed by a certificate from the independent Fraunhofer Institute for Experimental Software Engineering (IESE).
• Install locally and enjoy all the benefits of the testo Saveris CFR Software
Locally installed on the users’ PC, the testo Saveris CFR Software fulfils all the key requirements regarding validatable software:
• 21 CFR Part 11 compliant (validatable)
• Signing policies
• Allocation of access rights on three user levels
• Audit trail for the traceability of user activities
• With the testo Saveris CFR Software, you get documentation that will assist you with validation. The documents are based on GAMP5 and consist of:
• Customizable templates for risk analysis
• Customizable templates for the validation master plan and the validation specifications
• As well as fulfilling the requirements regarding validatable software, the testo Saveris CFR Software offers power users the following benefits:
• Client/server concept: the measurement data can be monitored by different PCs connected to the network
• Tamper-proof storage and more: all recorded humidity and temperature monitoring measurement data is centrally archived and stored tamper-proof by the testo Saveris CFR Software. At the same time, the testo Saveris CFR Software enables comprehensive analysis, graphical and tabular display and evaluation of all recorded measurement data
• Configuration of automatic and manual PDF reports (per day/week/month)
• Customizable alarm management system: more than two people can be notified, either at the same time or in succession, when critical values are exceeded. Depending on the day of the week and/or the time, the user chooses whether an alarm is implemented as an e-mail or an SMS
• Visualization of measurement data: users of the testo Saveris CFR Software can save photographs of machines or rooms and link these to the humidity and temperature monitoring measurement data. Visualization enables various measurement data to be assigned to the measuring location quickly and easily
• Tour planning with calendar management: for mobile data monitoring, the tour planning function offers clear presentation of planned and completed transport operations
testo Saveris CFR Software With Web Access Licence 1-5 Users
- İlaç endüstrisi için akıllı ve doğrulanabilir yazılım
- Tüm ölçüm parametrelerinin grafik ve tablo görüntüsü
- Raporların zahmetsizce oluşturulması ve yönetimi
- Maksimum güvenirlilik ve güvenlik için dijital imza ve denetim izi
ComSoft 21 CFR Part 11 yazılımı, Testo dataloggerların programlanması, okunması ve verilerin arşivlenmesi için doğrulanabilir bir yazılımdır. Tüm FDA’nın 21 CFR Kısım 11 gereksinimlerini karşılar.
Stok kodu: 0554 1705
Kategoriler: Aksesuarlar, Testo, testo aksesuarlar
Etiketler: aksesuar, lisans, saveris, testo, yazılım
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