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:
EBR - Electronic Batch Record systems
MHS - Material Handling systems
WMS - Warehouse Management systems
Distributed Control Systems (DCS)
LIMS - Laboratory Information Management Systems
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: