Compliant solutions

Workflow automation and digitalisation designed to meet the standards and requirements for regulated environments with assured business continuity.

Overview

Our Solutions

Development

Pre-validation as a standard

  • GAMP Category 4
  • Short time to business
  • Reduced qualification effort
  • Qualification documentation ready
  • Software validation certificate ready

End-to-end customised solutions

  • GAMP Category 5
  • Due to customisation longer projects and time to business timeline
  • Extensive testing prior the handover
  • Qualification documentation build during the development phase
  • Custom software and interface validation

Examples
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FLEX EP

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SWING SP

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FLEX POWDERDOSE

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FLEXSHUTTLE for end-to-end process automation.

Discover Chemspeed's first on market FLEX EP – a compliance-ready automated workstation for eluent preparation - seamlessly integrated with your lab information management system.

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Explore the possibility to improve the repetitive and time-consuming sample preparation for HPLC, GC, NMR, etc, tasks with automation and our proprietary tools for sample preparation.

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Small footprint with large throughput for your reference standards preparation, arching aliquotation, capping and labelling in one system, and enabling full data traceability.

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Our patent pending technology providing complete customisation and allowing to create the system as per your specific requirements and throughput required by combining and connect as many FLEX units as you like into one integrated platform while executing tasks in parallel, whilst samples are shuttled around the platform on the unique shuttle rails.

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Benefits

Powerful advantages

Chemspeed technologies supports your journey towards Pharma 4.0 by end-to-end workflow automation: starting with your input sample to the analytical data of the output sample. We integrate third party analytical devices and your laboratory data management software (LIMS), hence providing complete data integrity by design, increased productivity, and simplified compliance.

Solid and liquid material handling, filtering, shaking, centrifugation, ultrasonication, aliquotation operations are developed as per relevant regulations and requirements (ex., USP41, ISO8655, USP791, etc).

Robust and consistent workflow execution with high precision, throughput and data integrity.

3rd party devices integration (such as HPLC, GC, UV-Vis, centrifuges, etc).

Applicability throughout entire method life cycle from R&D to QC departments providing reduced risk of failure in technology transfers.

System supports electronic reports and signatures, complete audit trail and user roles.

Software complies with FDA’s 21 CFR part 11.