How can ASIS.TO help you?

Radio-tracer production control

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.
Batch Report & Release:
Generate automatic batch reports and QC documents

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.

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.

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 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.

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.

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

Dedicated reporting module for flexible reporting:
Dive deep into your operational data with a structured datamart designed for complex queries and cross-sectional analysis.
Multi-dimensional analysis datamart:
Extract data with predefined Excel report templates, enhanced with various Power Pivot analysis options.
Multi-widget reporting dashboard:
Complex reporting dashboards using a variety of visual widgets to track key performance indicators (KPIs) at a single glance.
Site level and network level reporting options:
Generate detailed reports for a single production facility or aggregate data across your entire multi-site network for executive oversight.
Possibility to integrate external BI Tools like Microsoft Power BI and Tableau:
Connect ASIS.TO's Reporting Module to Business Intelligence platforms like Microsoft Power BI or Tableau to leverage advanced enterprise-level analytics and visualizations.

Dedicated AI Agent:
Specifically trained Agent to understand the unique structure and meaning of your radiopharmacy data. Dedicated Agent toolset for customized data extraction.
Multi-LLM Flexibility:
Seamlessly connect with the industry’s leading Large Language Models through our flexible AI connector.
BYOK:
Bring-your-own-key and have full control over your AI expenses and model appliance.

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.

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.

Nuclear medicine generator handling:
Comprehensive tracking and management of your entire radioisotope generator lifecycle, from initial delivery to final disposal and return shipment.
Elution planning and scheduling:
Plan and organize daily elution schedules in advance to ensure optimal isotope availability for patient doses and production batches.
Generator intake and QC:
Streamline the receiving process with quality control checks, ensuring every generator meets regulatory and safety standards before use.
Technical and production elution tracking:
Monitor and record detailed metrics for technical and production elution.
Decay calculation and activity forecast:
Automatically calculate isotope decay for daughter and mother isotopes and forecast available activity levels to optimize production and generator usage.
Electronic elution logbook:
Replace paper records with a fully digital, GMP-compliant logbook that securely stores all elution data.

Flexible calendar view for batches, resources, elution, etc.:
Visualize your facility's schedule in an intuitive calendar interface, displaying production batches, equipment usage, and planned elution.
Sophisticated batch scheduling with recurring productions:
Easily set up complex production schedules, including recurring daily or weekly production cycles.
Personal allocation planning:
Assign specific staff members to production tasks and QC activities, ensuring your team is optimally utilized.
Device allocation planning:
Reserve cyclotrons, synthesizers, and hot cells for specific batches to prevent bottlenecks and maximize your facility's throughput.
Resource overlapping and conflict detection:
Automatically identify and alert users to scheduling conflicts, double-booked equipment, or staff allocation overlaps before they happen.
Monthly, weekly, daily view:
Seamlessly switch between different calendar perspectives to manage long-term planning or focus on the immediate daily workflow.

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.

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