SentroSuite GMP [ SentroSuite GMP ]
  • 제품명
    GmP compliant software
  • 제조사
  • 상세내용

모든 SentroPAT 시스템의 계측기 제어 및 작동을 위한 GmP 호환 소프트웨어


Main features

  • Comprehensive data analysis functionality including Moving F-Test, MBSD and RSD calculations
  • Flexible user management incl. support of domain user accounts
  • Full protection of system and result files incl. archiving functions
  • Integrated validation routines according to USP resp. EP 2.2.40
  • Documented audit trail
  • File encryption / file security
  • Real time prediction for methods generated with Unscrambler X and SIMCA-P (optional)
  • Continuous self- monitoring of the hardware and alarms in an event of critical system state
  • Display of measurements as spectra or trend views of monitored parameters (e.g. model / method output)
  • Full communication and control of the system by OPC (option to be ordered separately)
  • Optional interfaces to SiPAT (Siemens), SynTQ (Optimal Ltd.) and PharmaMV (Perceptive Engineering Ltd.)

Technical Data

Compliance Features

Audit trail
Comprehensive user management
Options for file encryption
File security service
Lock of Windows functionality
Prepared for integration to a domain

USP & EP 2.2.40
High Flux Noise
Low Flux Noise
Photometric Linearity
Wavelength Uncertainty
System suitability tests

Measurement stability
Wavelength filter test
Lamp check
Reference Check
Multivariate data analysis - external SIMCA Q
Unscrambler X
Multivariate data analysis - internal

Moving Block Standard Deviaton
Moving F-Test - contiguous blocks or configurable gap between blocks
Integral calculation
Statisical functions for calculated parameter (mean, standard deviation, relative standard deviation)

Baseline correction
Communication and Interfaces

Bi-directional OPC DA
SIPAT (Siemens)
SynTQ (Optimal Ltd.)
PharmaMV (Perceptive Engineering Ltd.)
Process Pulse (Camo)