PDS ClinPath Product Features
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Innovations
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a) Profile Driven :
A Profile relates to a collection of measurement parameters whose relationships one with another is intrinsic to the Profile. The use of Profiles is fundamental to the data collection function but becomes transparent when collating results for a sample (which can be derived from several different Profiles).
b) Super Profiles:
The SuperProfile concept allows profiles of measurement parameters, which may have their data collected via a variety of analytical equipment, to be grouped together for the purpose of verification and signoff. This facility greatly increases a technician's ability to identify anomalies which adds value to the Clinical Pathology end product..
c) Parameter hierarchy:
The relationships between reference parameters (profiles and Super Profiles) and measurement parameters has been refined so as to provide unambiguous and coherent analysis structures. The provision of an unlimited number of measurement parameters gives significant analytical capacity.
d) Squeezing Laboratory Operating Costs:
By making the Clinical Pathology system reflect the working practices of the ClinPath laboratory, greater efficiencies can be derived compared to systems where Clinical Pathology is subordinate to a wider data management facility. By making ClinPath the focal point of the system design, added value opportunities can be leveraged.
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| Data Collection
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a) Virtually any Instrument Supported
Instruments are peripheral laboratory equipment which communicate with computer systems using a variety of different protocols. No presumption has been built into ClinPath regarding the protocols that can or can not be supported: the system is designed to interface with any instrument via the provision of an instrument driver. Such drivers are purpose-built to meet client requirements. Through the use of connectivity standards, the introduction of a new instrument can never force a redesign of the kernel. Thus new instruments can be supported in an efficient and cost effective way.
b) Integrated Urine/Blood Microscopy
The SuperProfile technique enables the ClinPath user to invoke microscopy on the basis of value judgement decisions rather than by mandated protocol demands. This enhances throughput efficiency by reducing unnecessary analyses to a minimum.
c) High Volume Sample Throughput
The cycle from sample receipt through to data approval has been reduced to an intuitive sequence of interconnected processes having a minimum of mouse clicks and key presses. This, coupled with modern instrumentation and the intelligent use of microscopy, leads to high sample throughput. The ability of the system to scale to an unlimited number of sites across an unlimited number of environments ensures that the system can be tailored to meet any current or future level of demand.
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| Compliance |
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a) 21 CFR Part 11
The FDA final rule on electronic signatures has been mandated since 1998 but few systems yet comply. The PDS ClinPath system is fully compliant with this regulation.
b) GLP and cGMP
The principles of Good Laboratory Practice and Good Manufacturing Practice are embedded within the product which has been the subject of successful regulatory inspection.
c) Positive Sample Identification
A necessary part of ensuring that data are correctly ascribed to the samples from which they originate is achieved through positive sample identification. This feature is enabled by the use of bi-directional instrument interfaces which the PDS ClinPath system fully supports.
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| Connectivity |
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a) Multiple Sample Clients
By placing the Clinical Pathology system at the focal point, no one client (supplier of samples) assumes a greater priority than any other client. Therefore, by the use of manual and automated sample registration procedures, any supplier of samples can be handled as a regular client. This gives client scalability.
b) Multiple Data Repositories
Through the use of client-specific interfacing mechanisms, data can be transferred automatically to a data warehouse or other repository structure where relationships between ClinPath data and data deriving from other systems across the enterprise can be combined to leverage their intrinsic value. This gives data scalability.
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Data Storage
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a) Comprehensive Data Storage
The data from both QC and non-QC samples are stored in intelligently designed structures which preserve the data collection relationships and ensure maximal query accessibility. This satisfies the requirements of the regulator and the demands of the ClinPath client.
b) Comprehensive Data Reporting
In addition to the reporting functions which present information exactly as captured, sophisticated reporting tools provide tabular and graphical presentation of both QC and non-QC data. These value-added facilities maximize the benefits ClinPath clients derive from their data.
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| Technology |
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a) Client/Server
With client-side software and server-side data, the ClinPath is highly responsive and highly secure.
b) Microsoft
ClinPath is an all-Microsoft solution which can be deployed on any MS Windows-based configuration (Win 2000 preferred). Software is written in VB6 and utilizes remote data object connectivity (ODBC).
c) Open Systems
Connectivity guaranteed with all major databases (DBASE, Oracle, MS Access, MS SQL Server, etc.)
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