Order management / Batch planning: Record customer orders
Schedule production or research batches and track status changes. Assign orders to batches.
Production and dose management:
Monitor each production batch, record data during manufacturing and QC. Register and label production doses.
Track each production batch; document data during production and quality control. Register and label production doses.
Centralized repository for all electronic documents:
Store all your digital records and documents in one location, accessible from anywhere in your facility.
Revision and version handling:
Manage revision statuses and document versions effortlessly
Access control and electronic signatures:
Set access permissions for various documents and apply electronic signatures.
Multi-site management
Management dashboard with map overview:
A thorough summary of key production-related details from various facilities.
Data aggregations from different facilities:
The automated collection and aggregation of production-related information across various locations in real-time.
Multi-sire reporting:
Creation of summary reports for the complete production chain
Distributed inventory handling:
Planning and tracking in-house inventory transfers between different sites.
Share SOP definitions between sites:
Exchange process and workflow definitions across your sites to harmonize your operations.
GMP-compilant inventory process
Supllier Management:
Registration of approved Suppliers' data. Track supplier qualification.
Material Management:
Definition of consumable types. Definition of release acceptance criteria.
Inventory Management:
Automated stock level tracking and expiration management. Monitoring inventory release process. Label printing with barcodes. Site activity tracking for radioactive items.
Equipment integration and tracking
Equipment type setup:
Facilitates the grouping of similar instruments.
Equipment Lifecycle Management:
Calibration-, maintenance-, qualification status and digital document library.
Automated equipment data access:
Seamless, automated processing of production and QC device data from equipment PDF reports.
Flexible equipment integration:
Simple, scalable plugin technology with adaptable PDF processing for different equipment reports. A broad array of supported equipment includes cyclotrons, synthesizers, dispensers, QC, and more.
Digital Workflow Setup
Process definition (SOP) and workflow setup:
A what-you-see-is-what-you-get editor to setup your digital SOPs with various input and calculation fields. and combine them into complete workflows.
Flexible workflow designer to digitize your processes:
Intuitive graphical designer helping to combine processes into a complete production workflow.
Trend analysis
Analyze and visualize trending timelines for production and QC values:
Drill into your production data and reveal trends for different indicators in a matter of seconds.
Leverage the power of Excel Power Pivot to gain more detailed insight:
Export trend information into Excel and perform further analysis with the power of Excel Power Pivot
Quality management
Quality method definition:
Define your own QMS processes just as you like.
Deviation and CAPA management:
Track deviation and CAPA processes and generate QMS reports in electronic format.
Supplementary methods:
Track equipment qualification and validation processes. Consolidate change control activities in a single location.
Training and qualifications
Manage qualifications and certificates of lab employees:
Track team members’ qualifications and related certificates.
Organize trainings and manage in-house courses:
Record and organize training and in-house courses. Upload related electronic training materials.
Set qualification rules for material, equipment and SOPs:
Configure and verify qualifications for different activities and equipment handling.
Additional features
Multi-user:
Provide access for all employees as needed.
Full audit trail:
Detailed audit trail for each user interaction and data changes.
21 CFR Part 11 / EU Annex 11 compliance:
Compliance with 21 CFR Part 11 / EU Annex 11 regulations.
Multi-language:
Effortlessly switch the display language to your preferred option.
