Ozmometreler
OsmoTECH | Mikro Ozmometre
- İlaç sanayi için
- Numune kapasitesi : Tek numune
- Numune hacmi : 20 ul
- Numune verme : Tek-adımda direkt numune verme
- Ölçüm aralığı : 0-2000 mOsm/kg H2O
- Ölçüm süresi : 90 saniye
- Sıcaklık kontrol yöntemi : Kuru soğutmalı
- Haberleşme : Eternet, USB(3), gömülü web-sunucu
- Yazıcı : Harici yazıcı bağlanabilir
- Barkod tarayıcı : Entegre barkod tarayıcı
- Ekran : Dokunmatik, Türkçe menü
OsmoTECH™ Single-Sample Micro-Osmometer 21 CFR Part 11 Compliance
The FDA 21 CFR Part 11 regulation applies to records and systems where data is saved in an electronic format.
The OsmoTECH software has been designed with data integrity and security features which allow it to be integrated into Part 11-compliant laboratory environments.
The test results and associated data cannot be edited and the system provides easy access to review data and securely transfer data to the customer’s laboratory information system (LIS).
The instrument has the following Part 11-compliant features:
Fraud Detection: Test result records cannot be edited once the test has completed. Results data is available for export (if enabled by supervisors).
Audit Trails: Audit trail records are time stamped and cannot be modified by users of the system. Audit trail data is available for export (if enabled by supervisors).
Password security: Required 8 character Alpha/Numeric password. User lockout after 4 attempts and allows users to set times for new password creation from 30, 60, to 90 days.
Access Controls: The system allows for system administrators (supervisors) to set up individual user accounts on the OsmoTECH. This allows the system to track which user performed each test. The creation of duplicate user IDs is also prevented.
Secure LIS Link: The software can be integrated into the Laboratory Information System (LIS) to allow a secure data transfer between the OsmoTECH and the customer LIS through TCP/IP communication protocol.
Embedded Web Server: On local network, remotely view, print and download test data and system information securely from OsmoTECH. Ability to print or electronically save each procedure using a standard browser.
Network time synchronization: Simple Network Time Protocol used to synchronize the internal Real Time Clock with a network time source. Electronic Signatures: User passwords are suitably encrypted for data storage.
Event Database: The system records any changes in an event database. This includes creation/deletion of users, deletion of databases, and any changes made to the system set-up.
