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PAS-X Full Scope Packages
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| Clinical Trial Supply Management for
Pharmaceutical Industry
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 download brochure
(pdf, 654 KB)
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PAS-X CT is the full scope package for clinical trial manufacturing in pharmaceutical industry. The software can be used in all clinical phases and is tailored for staff members who work in the areas of production and distribution of clinical trial medications.
Employing PAS-X CT will benefit you in:
- Saving time in the production of clinical trial medications
- Increasing safety when packaging clinical trial medications
- Making workflows more efficient owing to easy and intuitive operation
PAS-X CT supports all aspects of supply chain optimization for the manufacturing of clinical trial medications. PAS-X CT's core functions basically cover four operational areas:
- Study management
- Production process management for clinical trial medications
- Management of packaging and labeling processes
- Warehouse management and shipping
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| Saving Time by Automated Workflows |
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Process steps and workflows related to the manufacturing of clinical trial medications
become highly automated when relying on PAS-X CT. The system supports the user in every
phase of the production process, slashing the time consumed by routine tasks - so the user
can concentrate on business processes instead.
Because of the study-specific definition of so-called label lines the IMP labeling and packaging sequences
are determined already during the stage of study design. Electronic control and verification of the process
steps ensure accurate monitoring of the manufacturing and packaging processes.
Defined electronic release workflows serve to speed up the coordination and control process. Moreover, the
documentation of the processes is performed automatically.
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Manual Clinical Supplies Labeling |
At the same time, the reliable and expeditious IMP production ensures that patients are supplied with the
medications they need - on demand and just-in-time.
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| Increasing Safety by Technical Support |
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Problems like mix-ups, medication errors, insecure blinding or insufficient documentation
threaten the success of clinical studies. PAS-X CT takes up these challenges by translating
the specifications of the study design into easy-to-follow and clear instructions. So, the
likelihood of human errors in the packaging and labeling processes is significantly reduced.
Additional security is ensured by a barcode-based automated verification system.
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| Modular Structure enables Step-by-step Extension |
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The modular structure of PAS-X CT allows you to start with a small-scale or partial
solution (e.g. labeling) and to gradually extend it until a complete system has been
achieved. It is up to you to decide if and when you want to extend or complete the
functions of your solution.
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| Smooth Integration |
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PAS-X CT integrates itself smoothly into already existing IT landscapes. Standardized
interfaces make it possible to connect to ERP systems, to clinical study management
solutions, to Laboratory Information and Management Systems (LIMS), to Document
Management Systems (DMS), to training management systems as well as to analysis
and reporting tools. |
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| cGxP Compliance |
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Documentation of manufacturing and packaging processes is paperless and in compliance
with cGxP requirements (Electronic Batch Recording). Modifications are stored - based
on an audit trail function - in a Historian Database.
Every single medication of a patient can be tracked down and monitored with regard to shipping, packaging,
manufacturing, input materials used and specifications of the study design.
PAS-X CT allows validation. The software development process follows the principles of the Software Development
Life Cycle (SDLC) in GxP environment. Delivery of the software takes place upon successful completion of a Site
Acceptance Test (SAT). A qualification package serves to reduce the amount of work required to validate the system.
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| Benefits of PAS-X CT |
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Mit demThe potential benefits the use of PAS-X CT produces are:
- Significant time savings due to automated processes
- Optimized safety in IMP packaging
- Increased efficiency thanks to high usability
- Automatic generation of electronic packaging records
- IMP shipping including track & trace functionality
- Modular structure
- Seamless integration
- cGxP Compliance
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| Overview of PAS-X CT Functions |
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With regard to the manufacturing of clinical trial medications, PAS-X CT offers all
basic functions including:
- Study management
- Electronic packaging instructions
- Randomization
- Label design and printing
- Weighing and dispensing
- Electronic Batch Recording
- IMP tracking and tracing
- Warehouse management
- Shipping
- Deviation and event management
- Equipment management
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Automated Workflows 