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OsmoTECH XT Single-Sample Micro-Osmometer User Guide
Appendix F: OsmoTECH XT Data
Management Features
F.1 Overview
Biopharmaceutical manufacturing involves many
complex operational steps. Consequently, compared to
other business sectors that use osmometers,
biotechnology firms and professionals have stricter
requirements, and expect their instruments to:
• Ensure the integrity of collected and stored data
• Comply with 21 CFR Part 11
• Save data over a network connection
• Support Open Platform Communications Unified
Architecture (OPC-UA)
• Facilitate paperless labs
• Support active directory servers, eliminating the need
for local users
The OsmoTECH XT was developed to meet the needs of
the Biotech community, and provide an easy-to-use,
menu-driven touchscreen interface to access instrument
features
Data management features
The OsmoTECH XT provides the following data
management features:
• OPC-UA support to easily integrate test results into a
data management system and/or batch records
• Export data to PDF or CSV to quickly save data to a
network folder (local save to USB also available)
• Database backup to protect your data (select
automatic or manual backup)
• Simple Network Time Protocol (SNTP) support for
synchronizing system time with a network server,
eliminating the need to manually manage date/time
• Embedded web server to remotely view and manage
data
• Optional storage of test results data on the system
• LIMS/LIS support to easily connect and track samples
and data
Data and user security features
The OsmoTECH XT provides the following security
features that support 21 CFR Part 11 and EU Annex 11
Compliance:
• Three levels of user access, allowing you to configure
user accounts that reflect the hierarchy of your team.
• Active directory/ Lightweight Directory Access
Protocol (LDAP) support that aligns with your IT
network to minimize manual input.
• Configurable password protection to match your
company’s internal security requirements.
• Pre-expire passwords that require users to change
their password the first time they log in, ensuring
maximum security.
• An automatic logout timer to keep your data safe
during system inactivity.
• An audit trail that can save virtually unlimited results
and events records.
• System change management that requires users to
record a reason for changing instrument settings.
• 2nd signature feature that requires two dierent users
to sign o on test result reviews and approvals.
Refer to Configuring settings for instructions on using
these features.
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