ApplicationPAKs
VelQuest has configured its SmartLab solution as ApplicationPaks designed to provide an environment for your group to quickly evaluate the platform at minimal costs then expand as needed. Each ApplicationPak contains a suite of pre-validated application templates that can be configured for your specific production needs, instrument integration and licenses to get you up and running (validated or non-validate) in as little as 45 days.
Click on the links below to find out more about our ApplicationPAKs:
The Raw Materials ApplicationPak is a low cost, rapid deployment product configuration of VelQuest’s award winning SmartLab GMP Electronic Notebook System to automate the standard USP-based test methods for raw materials testing. The system integrates all aspects of the testing procedures including presenting the approved test method to the analyst on a hand-held PC, connection of the system to testing instrumentation (balances, pH meters, AA’s, HPLC’s etc.) and automated data capture, cataloging and review processes. The ApplicationPak contains USP-based test templates that can be configured to your specific product testing specifications. In addition, VelQuest’s library of instrument connections and validation documentation provides a “go-live” in your cGMP environment in about 45 days.
The SmartLab RMT ApplicationPak utilizes VelQuest’s SmartTest technology where the USP-based method is templated and specific test parameters for each raw product is listed in a separate spreadsheet. Typical test templates include:
<191> Identification Test – General
<211> Limit Test – Arsenic
<216> Limit Test – Calcium, Potassium and Sodium
<221> Limit Test – Chloride and Sulfate
<231> Limit Test – Heavy Metals
<731> Physical Test – Loss on Drying
<733> Physical Test – Loss on Ignition
…..and many more
Download our Raw Materials ApplicationPAK literature
Register for our Raw Materials ApplicationPAK webinar to learn more
Contact Us to Find out More about this ApplicationPAK.
The SmartLab Calibration ApplicationPak automates the routine method execution and data capture validation and calibration tasks required for instruments in cGMP operations.
With the Calibration ApplicationPak, all the manual tasks associated with performing routine calibration tasks for simple and complex instruments are automated. Instruments such as pipettes, HPLC’s, balances, pH meters, titrators, spectrophotometers, dissolution testers, particle size analyzers, etc. that require routine calibration for cGMP use can be implemented with the Calibration ApplicationPak. Lab analysts/technicians view the instrument calibration test method from a tablet PC and execute the procedure with data capture for each step of the procedure done in real-time. The procedures are your current test methods as written in MS Word and loaded for use in the Calibration ApplicationPak.
Download our SmartLab Calibration ApplicationPAK literature
Contact Us to Find out More about this ApplicationPAK.
The SmartLab™ CDS ApplicationPak automates sample data input, and post-run evaluation, calculations, reporting and IT integration for the commercial Chromatography Data Systems (CDS).
The SmartLab CDS ApplicationPak is a LIMS to CDS integration/link technology for comprehensive data evaluation, analysis and sample prep integration requirements of today’s modern CDS systems. The CDS ApplicationPak is powered by SmartLab technology and takes the data from the output of the CDS system and transcribes the data stream into an XML format for powerful and flexible automated evaluation, calculation and distribution to any output target application such as a lab report or any LIMS. The application is non-invasive to the CDS operation. In addition, the CDS ApplicationPak contains an input template to automatically push all sample preparation information into the CDS prior to the run. This input information can come from any LIMS, the SmartLab GMP Electronic Notebook or manual operation. This process reduces the analyst’s pre and post CDS run workload from hours/day to minutes.
The significant productivity and compliance benefits include:
- Reduction of analyst’s workload for post-run CDS operations from hours/day to minutes.
- Automated peak count assessments to eliminate the risk of missed degradation products or impurities in the samples with automated restatement of results.
- Automated and validated calculations (including LLQ values, system suitability etc.) remove the risk of any human error in this important quality assessment operation in GMP areas.
- Automated (and validated) data transfer to a final report (in-house template or LIMS) eliminates transcription errors and the need for time consuming peer review processes.
- Since the CDS ApplicationPak is powered by the SmartLab core system, additional method-based applications like reagent preparation procedures and analytical test methods can be added at any time to complete a full GMP Electronic Notebook System.
Download our CDS ApplicationPAK literature
Register for our SmartLab CDS ApplicationPAK webinar to learn more
Contact Us to Find out More about this ApplicationPAK.
Instrument to LIMS Interface ApplicationPak
Similar to the LIMS ApplicationPak the Instrument to LIMS Interface ApplicationPak provides a direct link with any PC-based or serial-based instrument for compliant data capture and exchange. This product configuration includes instrument integration, with our advanced parsing engine to capture and catalog any data elements needed for cGxP operations. The system is expandable at any time to include other SmartLab functions (eg. Method execution etc.).
Register for our Instrument to LIMS Interface ApplicationPAK webinar to learn more.
Download our Instrument to LIMS Interface ApplicationPak literature
Contact Us to Find out More about this ApplicationPAK.
Finished Product and Stability Testing ApplicationPak
Finished Product and Stability Testing ApplicationPak is a series of final product test templates including Content Uniformity, Dissolution Testing, ID and Assay are configured with instrument integration and system validation. The method templates represent best-practices from pharmaceutical industry leader deployments and are 95% complete – with specific product configurations finalized for your individual methods.
Download our Finished Product and Stability Testing ApplicationPak literature
Contact Us to Find out More about this ApplicationPAK.
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