AUTOMATION METROLOGY & VALIDATION 

PHA.SE. issue and perform Computer System Validation documentation for the automated system located in the facility (new and existing systems). PHA.SE. carry out these activities accordingly to a GAMP compliant approach in compliance with the international guidelines and regulation (i.e. CFR 21 Part 11, etc.) on the following systems typology:

Manufacturing area
  • EBR - Electronic Batch Record systems
  • MHS - Material Handling systems
  • WMS - Warehouse Management systems
  • Dispensing systems
  • Distributed Control Systems (DCS)
  • SCADA systems
  • PLC systems
Laboratory area
  • LIMS - Laboratory Information Management Systems
  • Laboratory Instruments

PHASE with its expertise in automation, provides systems completely customized, realizing the proper solution for their Client processes. Considering either the hardware and the software developing in accordance with international standards and current regulation. PHASE supports also its own Clients in the definition and procurement of the required process instrumentation. Moreover provides maintenance & calibration services on existing or new on board instrumentation, using its own master instrumentation with NIST certification.
In particular PHASE supports its Clients with the following expertise in automation:

  • Industrial processes and systems automation
  • Custom system development
  • Technical support
  • Hardware e Software Engineering
  • Application Software Development
  • Training
  • Assistance, start-up, maintenance
  • Risk assessment, 21CFRpart11 compliance
Software development
  • Functional Specification (Block Diagrams, Pin-Charts, Alarm List)
  • Hardware Design Specification (PLC & SCADA)
  • So ware Design Specification (PLC & SCADA)
  • Hardware e Software Engineering
  • Supervise the software implementation to make sure it will comply with Customer expectations
  • Coordinate the Software developers