Il team di Advisory di Particle Measuring Systems ti supportano con gli strumenti e le strategie di implementazione necessari per controllare la contaminazione nelle tue operazioni critiche, dall’idea iniziale fino alle applicazioni successive all’implementazione. I nostri esperti ti aiutano a integrare la qualità nei tuoi processi operativi, grazie agli strumenti PMS di riferimento nel settore e ai servizi di Advisory, riconosciuti come standard di eccellenza.
Facility Monitoring Systems - FacilityPro®
- FacilityPro Process Mapping service includes the creation of all the specifications for the configuration and system settings (for example: recipes, alarms and warning limits, equipment, user types, etc.).
- FacilityPro Performance Qualification (PQ) documentation creation and execution. Assistance includes defining and creating the PQ documents and test procedures.
- FacilityPro SOP Creation (1 SOP) includes defining and creating one (1)
- FacilityPro data management system SOP (Standard Operating Procedures) document. The Standard Operating Procedure may include:
- FacilityPro use and operation
- Support for defining trends and creating reports
- Audit trail retrieval and review
- User management processes
Microbial Monitoring - BioCapt® Single Use
- Performance Qualification protocol (PQ) for standard applications
- Performance Qualification protocol (PQ) for non-standard applications
- Support for the review and interpretation of qualification results.
- Rationale for the removal of settle plates with the implementation of Biocapt Single Use
Compliant Data Management and Trend Analysis - PharmaIntegrity™
User Requirement Specifications including:
- Process Mapping
- Performance Qualification (PQ) protocol writing and assistance performing the approved procedure
- SOPs
