Biopharma and Bioprocess
- From cell line development through upstream and downstream processing, use event driven Scitara DLX Orchestrations to maximize process integration, automation and efficiencies
- Connect to streaming data systems and non PC based instruments
- Unique IoT interface for simple instruments speeds up analysis and improves data integrity
- Data aggregation support throughout the entire bioprocess
- Event driven notifications inform you of steps needing review or action by the lab team
- Data integrity and maintaining a GxP compliant environment for simple instruments that do not have a connected PC has historically been a challenge, requiring a combination of manual lab notation and witnessing.
- Scitara DLX™ brings this process in to the 21st century using a unique Scitara secure IoT device that is linked to the device by a hash code.
- The IoT device may be identified by a QR code scanned by a phone or tablet. After scanning the users must log in establishing a clear chain of custody. The Scitara DLX user interface provides control of the device and all actions are captured by the Scitara DLX audit trail. Once the data is captured, it becomes part of the Scitara DLX™ event stream . The ability to add notes and a picture or video of the activity is supported.
Data Integrity for Data in Flight
- Within Scitara DLX™, data in flight between instruments, applications or repositories are managed by Scitara DLX™ Orchestrations and become part of the Event Stream.
- Orchestrated activities that take place within the Event Stream are all tracked and logged in the Scitara DLX™ Audit Trail establishing a clear chain of custody as data is moved, merged or transformed.
- This allows reconstruction of complete workflows weeks, months or years after the fact and extends support for GxP compliant processes to data in flight.