Thermo Scientific™ SolstiX™ XRD Software with Security Suite is designed for the Thermo Scientific™ ARL™ EQUINOX X-ray diffractometer range and enables compliance with 21 CFR Part 11 (Electronic Records / Electronic Signatures).
Security Suite Software integrates directly into SolstiX Software and provides advanced data security and integrity tools to meet regulatory requirements. The software logs changes to files associated with SolstiX Software, even when the software itself is not running.
Key Features
21 CFR Part 11 Compliance
- Meets FDA Code of Federal Regulations Title 21, Part 11 requirements
- Designed using a strictly controlled Product Development Process (PDP)
- Full traceability in specification, revision control, and software validation
Full System Access Control
- Works with Windows security to authenticate operators
- Software access controlled per user on single or multiple instruments
- Can be configured per user, per system, or enterprise-wide
True Digital Signatures
- Cryptographic user authentication
- Encrypted secure hash validation of signed files
- Detects file tampering
- Digital signature history included in audit trails
Complete Audit Trails
- Non-editable spectral data processing histories
- Tracks:
- Changes to data by any operator
- Digital signature history
- Comments added to collection information
- Data collection information
- Errors during data collection
- Event logging includes:
- Security Administration database changes
- Security Server activity
- File creation, modification, renaming, deletion (even when software is not running)
- Log-on, log-off, failed log-on
- File signing and failed signing events
Entries include user name, date and time (with GMT reference), and reason for change. The history is embedded in the spectral data file and is not editable.
Thermo Scientific SolstiX XRD Software with Security Suite: This comprehensive activity tracking and logging assures you the ability to create detailed audit trails for your XRD instrument, and the data it generates.
Flexible Record Storage and Retrieval
- Automatic saving of original raw data
- Enables reproduction of experiments
- Includes:
- Final format data
- Sample interferogram
- Background interferogram
- Retrieval and review in Thermo Scientific™ OMNIC™ Software or database/graphical programs
- Automatic saving without operator intervention
- Archiving options
- Copying spectra and reports in graphical format to external programs
Thermo Scientific SolstiX XRD Software with Security Suite: Y₂O₃ powder diffractogram.
Thermo Scientific Security Administration Server
The Security Administration Server provides centralized control over:
- Software access
- System policies
- Digital signature meanings
It can run:
- Stand-alone on an XRD workstation
- As a server application to administer one or multiple systems
Capabilities include:
- Prevent overwriting of files
- Require digital signatures on file saves
- Require reason entry when data is changed
- Prevent changing directories when opening/saving files
- Automatically lock workstation after inactivity
- Control access to software features
- Add, delete, or edit signature meanings
- Preview and print user settings for inspection
The system allows high security while maintaining productivity. Once configured, settings can be locked to prevent modification.
Thermo Scientific SolstiX XRD Software with Security Suite.
