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13 September 2013

Software Solutions

ACCREDIA – Italy’s National Accreditation Body

ISO – International Organization for Standardization

 

Companies operating in compliance with GxP international quality standards (Good x Practices, such as ACCREDIA and ISO) need software to manage in an integrated manner multiple kinds of data and to automate all main production processes.

We have at your disposal standard solutions and we develop customized software for systems and workflow management and automation, to increase efficiency in all business areas, from laboratory or industrial prototype equipment, to integrated data management (ERP, MES, LIMS), to flow management in production or logistic areas (storage areas, monitored condition and flow areas, etc.)

 

Our Solutions

  • Development of customized software for complex workflows management on laboratory or industrial equipment (ex. dissolution test, auto sampler automation, automation of data flows from all main software for chromotography management and any kind of equipment management, automatic production line management etc.)
  • Reprojecting of firmware of currently in use hardware
  • Software for management of quality systems documentation, such as SOP (standard Operating Procedures) or of Change Controls
  • Drafting and following assessment of RFP (Request For Proposal), USR (User Specification Requirements) and System Design for your software and hardware systems to implement or purchase
  • Performing of UAT/SAT tests (User/Site Acceptance Test) as end users to assess conformity with initially stated requirements
  • LIMS interfaces (Laboratory Information Management System) to combine analytic laboratory equipment with quality system documents
  • PIMS interfaces (Plant Information Management System) to manage and record in real time all data and settings from company plants, remote
  • Paperless Lab: software for management of automatic systems to record laboratory data
  • ELN (Electronic Lab Notebooks) and MES (Manufacturing Execution Systems): software for management of laboratory experiments and workflows or industrial and logistic processes (ex. storage area, dispensing room, pick-up list) in full compliance with reference regulations
  • Management of time table of calibrations, adjustments and preventive maintenance of instruments, machinery and plants
  • Management of product timetable (ex. laboratory reagent cabinet, industrial reactives, stored goods)
  • Management and automated updating of MSDS product safety sheets (Material Safety Data Sheet) and resulting GHS labelling (Globally Harmonized System of Classification and Labelling of Chemicals)
  • Software for biobank management
  • Validation plan of currently in use information systems, also for CDS (Chromatography Data Systems)

Implementing or updating a CDS (Chromotography Data Systems) or a MES (Manufacturing Execution Systems) may be a complex procedure which involves several groups, from laboratory to Information Technology and, for regulated settings, also quality assurance. In such cases the support of a consultant becomes very useful, and even necessary, to coordinate and/or perform the various activities.

 

Use Cases

  • To automatize workflows, machinery and equipment in laboratories, production and logistic areas in general
  • To automatize critical processes minimizing the eventuality of human error
  • To streamline time and resources required in terms of man/hours
  • To standardize operations, increasing quality and reducing costs due to possible reprocessing caused by procedure errors
  • To record of all data in real time and acquire more information about one’s processes or flows, consequently allowing a reanalysis with the aim of reducing costs
  • For laboratories, GxP production and/or logistic areas which must comply with CFR21 Part 11 or EU Annex 11 regulations and undergo inspections from authorities such as FDA (Food and Drug Administration) in the United States or ISS (Istituto Superiore di Sanità Italiano – Italian National Health Service) in Italy and other national or international authorities which expect a documentation of currently in use systems. Non-compliance with these regulations might result in warning letters and even a ban from certain markets
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