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| Clinical Trial Supply Management for the Pharmaceutical Industry
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(pdf, 654 KB)
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The development of a pharmaceutical product is a complex process with
rigidly controlled regulations. Time is a major factor since it may often
take ten years or more to move a drug from pre-clinical phase to its
approval (time to market).
PAS-X CT is a software for the management of manufacturing CT medications in
the pharmaceutical industry; it is used during all clinical phases. PAS-X CT
is designed for personnel directly engaged in the manufacture and distribution
of clinical trial medications.
The functions of the software address these three key business objectives:
- Saving time when producing clinical trial medications
- Increasing safety when packaging clinical trial medications
- More effective workflows due to simplified and intuitive operation
As the following diagram illustrates, PAS-X CT supports all aspects of supply chain
optimization for the manufacturing of clinical trial medication.
The core functions of PAS-X CT primarily cover these four operational areas:
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| Automated Workflows Save Time |
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To a high degree, PAS-X CT automates the processing steps and operations for
manufacturing clinical trials medications. The system supports the user
during every phase of the manufacturing process; this enables the operator
to dramatically reduce his time investment for routine tasks, and instead
focus on the business process.
Because of the study-specific definition of so called label lines, the IMP
labeling and packaging sequences are defined in advance during the study design.
The electronic verification of the processing steps ensures the most accurate
monitoring of manufacturing and packaging.
Electronic release workflows stored in the database speed up the coordination and
control processes. The documentation of these processes is also automated.
The reliable and timely IMP manufacturing serves as the basis for a
distribution of the medications to the patient just in time (on-demand).
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| Safety First |
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Problems such as mix-ups, faulty medications, insecure blinding or insufficient
documentation jeopardize the success of clinical studies. PAS-X CT addresses these
issues by converting specifications defined during the study design into simple and
clear instructions during operations. This greatly reduces the potential for human mistakes
during the packaging and labeling processes. Additional security is insured by the use
of barcode-based automated verification.
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| Intuitive Usability due to Optimized User Friendliness |
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"Usability is the extent to which a product can be used by specified users to
achieve specified goals with effectiveness, efficiency and satisfaction in a
specified context of use"
(ISO 9241-11)
We have placed a high priority on developing dialogs that are user friendly.
The design and layout of the dialogs and forms provide intuitive guidance to
the users, and enhance the usability and ergonomics of the software. The software
and its layout have been tested according to ergonomic standards (ISO 9241,
section 10-17) as well as best practice considerations.
User groups were consulted throughout the development of the software,
and have had a significant impact on the final design of the software interface.
Due to the integrated system of access rights and roles, the individual
users only need to navigate through dialogs which are relevant to them.
The complexity of the workflow is therefore reduced for the user resulting
in higher data quality within the entire system.
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Color coding simplifies
the user‘s orientation within
the complex packaging processes
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Consequent adherence
to defined design principles
for dialogs leads to an
intuitive usability
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| Modular Structure |
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| The modular structure of the PAS-X portfolio allows the customer to start with
an initial or partial solution (e.g. labeling) and build an installation in a
step-by-step fashion until a complete system has been built. It is up to the
customer to decide if and when to extend or complete the solution functionally.
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| Seamless Integration |
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PAS-X CT integrates itself seamlessly into already existing IT architectures.
Standardized interfaces make it possible to connect to ERP systems,
to clinical study administration solutions, to Laboratory Information
Management Systems (LIMS), to Document Management Systems (DMS), to training
management systems, as well as to analysis and report tools.
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| cGxP Compliance |
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The manufacturing and packaging process are paperless and in compliance to cGxP requirements
(Electronic Batch Recording). Modifications are stored – based on an audit trail
function – in an Historian Database.
Every individual patient medication can be tracked and monitored with regard to
shipping, packaging, manufacturing, materials used, and specifications of the study design.
PAS-X CT is ready for validation. The soft-ware development process follows the
principles of the Software Development Life Cycle (SDLC) within GMP environments.
Delivery of the software occurs upon acceptance of a Site Acceptance Test (SAT).
A qualification package reduces the amount of work needed to validate the system.
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| Benefits PAS-X CT |
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- Significant time savings due to automated processes
- Optimized security in IMP packaging
- High usability to ensure increased efficiency
- Automatic creation of electronic packaging records
- IMP shipping including track & trace functionality
- Modular structure
- Seamless integration
- cGxP compliance
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| Functional Highlights PAS-X CT |
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- Study management
- Electronic packaging instructions
- Randomization
- Label design and printing
- Weighing and dispensing
- Electronic batch recording
- Tracking and tracing
- Warehose management
- Shipping
- Deviation and event management
- Equipment management
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