testo 21 CFR Part 11 software for Saveris
- CFR basic package with Web Access – licence for 1 to 5 users
- testo Saveris CFR Software: validatable client and viewer software including database for installation on the PC or server
- testo Saveris Web Access: monitor measurement data flexibly from any terminal device via the browser – without installing any software
- Analysis and graphical/tabular display of measurement data, customizable alarm management and reporting
Click Here to Saveris CFR Certificate
Click Here to CFR Software Datasheet
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.
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).
Testing was carried out by the Institute in accordance with the evaluation guidelines of the GAMP Special Interest Group: Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures. The CFR software is therefore ideal for use in regulated sectors of the pharmaceutical industry.
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
- View measurement data via your browser with testo Saveris Web Access
Thanks to testo Saveris Web Access, basic users of the testo Saveris data logger system can retrieve their measurement data conveniently, saving themselves a lot of time in the process. With testo Saveris Web Access, there is no need to install the testo Saveris CFR Software on every single PC. Instead, users can conveniently access the measurement data via their browser and enjoy these benefits:
- A high degree of flexibility: measurement data from humidity and temperature monitoring can be viewed via the browser using a variety of terminal devices (PC, smartphone or tablet). Depending on the configuration of the IT infrastructure, it is possible to use testo Saveris Web Access via both the Intranet and the Internet. Needless to say, in both cases browser access is via secure login
- Intuitive user interface: the testo Saveris Web Access user interface is intuitive, with no need for any time-consuming training. It offers the most important functions that the basic user needs in order to read measurement data and acknowledge alarms. Please note that you cannot carry out any system configurations via the testo Saveris Web Access functions. You need the testo Saveris CFR Software to do this, as before
- System requirement: Microsoft IIS 7.5 or later is required to install testo Saveris Web Access
Do you have more than five employees who wish to access humidity and temperature measurement data on the testo Saveris data logger system? No problem, we have put together additional licence packages for more users:
- Licence for an additional user (order number: 0572 0193): with this licence, you can activate an additional user of the testo Saveris CFR Software and allow the user access to the measurement data via testo Saveris Web Access
- Licence for an unlimited number of users (order number: 0572 9999): with this licence, you can activate an unlimited number of users of the testo Saveris CFR Software and allow the users access to the measurement data via testo Saveris Web Access
testo Saveris CFR Software basic package with testo Saveris Web Access on CD-Rom and instruction manual
Ethernet connection cable (from the testo Saveris base to the PC)
21 CFR Part 11 certificate
Documents to assist with validation
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