End-to-end LIMS solution for the entire tracer product
Production planning / Batch execution • Flexible Workflow Designer • QMS Document Management
Radio-tracer production control
Order management / Batch planning • Production and dose management • Batch Report & Release
QMS Document Management
Centralized repository for all electronic documents • Revision and version handling • 
Multi-site management
Management dashboard with map overview • Data aggregations from different facilities • Multi-site reporting • 
GMP-compliant inventory process
Supplier Management • Material Management • Inventory Management and release • Label printing & barcode scanning
Equipment integration and tracking
Equipment type setup • Equipment Lifecycle Management • Automated equipment data access • Flexible equipment integration
Digital Workflow Setup
Process definition (SOP) and workflow setup • Flexible workflow designer to digitize your processes
Trend analysis
Analyze and visualize trending timelines for production and QC values • 
Quality management
Quality method definition • Deviation and CAPA management • Supplementary methods
Training and qualifications
Manage qualifications and certificates of lab employees • Organize trainings and manage in-house courses • 
Additional functions
Full audit trail • 21 CFR Part 11 / EU Annex 11 compliance • Multi-language
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ASIS.TO is a scalable and flexible system that supports both research and production activities. It includes features to help ensure GMP during production, but there are override options available for deviations. When in research mode, GMP enforcement is disabled. Even with a small research team, ASIS.TO can assist in organizing your data and documents, automatically tracking your inventory, and helping you generate various reports and documents.
Amongst others, ASIS.TO gives significant benefits in 3 key areas:
• Boosts Speed, reduces mistakes: Automates data capture from various lab devices, and generates batch reports and other documents within a matter of seconds.
• Guarantees Release: Enforces mandatory SOPs and provides instant digital batch review, speeding up the critical release process for short-lived radiopharmaceuticals.
• Ensures Compliance: Provides non-negotiable audit trails and electronic signatures (21 CFR Part 11).
ASIS.TO is designed to comply with 21 CFR Part 11, EU Annex 11 and GxP with several different features:
• Auditable e-signatures are enforced for all critical steps like validations and batch release, providing an equivalent to wet signatures.
• Audit Trails: Every action, modification, and data entry is recorded with a timestamp, user ID, and detailed description, creating a complete, tamper-proof history of all user activities.
• Automated Workflows: The system enforces your approved SOPs, preventing non-compliant steps and ensuring a consistent and auditable process from starting material to final release.
The system can display alert limits and expiration dates. Specific calculations can be set for the radionuclide half-life and particular product specifications, which are automatically calculated during production.
• Out-of-trend and specification thresholds are monitored in real-time, with warnings and errors are triggered in case of threshold violations
• Warnings and errors regarding deadlines for inventory expiry, equipment maintenance, and calibration are shown to the appropriate QA team and technicians.
• Calculations for decay corrections can be configured, reducing manual calculation errors during production.
ASIS.TO features a comprehensive inventor management module that tracks all consumable and raw material intake, inventory quality assurance, and release. It also monitors final product doses and QC samples, especially for hot elements. Waste management and disposal are included within this module as well. The LIMS provides automated, transparent tracking for each inventory item with detailed history records.
Yes, absolutely. ASIS.TO has a flexible equipment integration framework offering integration options witha wide range of lab equipments and much more.
ASIS.TO offers a broad array of flexible configuration options, and our implementation team follows a straightforward process for preparations and installation. With that, the implementation can be completed within a few months, although the exact timeline depends on the specific customer needs. We provide ASIS.TO at a transparent, one-time, all-inclusive, fixed price with no hidden fees. The pricing includes software usage rights as well as preparation, installation, and qualification activities.
Our proven implementation process aims to minimize the customer's resource commitment. Our analysts and software technicians handle most of the preparation and installation tasks. Through online training, we offer a flexible and efficient way for your team to acquire the necessary knowledge to operate the system in their daily routines. We perform IQ and OQ as well and support your team when it comes to PQ.
The flexible workflow designer is a central feature of ASIS.TO, enabling process changes without requiring any software modifications. Your team can easily implement any necessary adjustments with clearly tracked revision management. In addition, ASIS.TO provides a variety of configuration options on different user screens.
Yes, it is crucial to feed your existing information into the system before it is started up. Our implementation team offers a wide range of migration possibilities, using different migration tools and techniques.
