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PRODUCT 제품소개
QbD/PAT
SentroSuite GMP [ SentroSuite GMP ]
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- 제품명
- GmP compliant software
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- 제조사
- SENTRONIC
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- 상세내용
모든 SentroPAT 시스템의 계측기 제어 및 작동을 위한 GmP 호환 소프트웨어
OVERVIEW
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 |
| Validation |
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) |
| Pretreatments |
Smoothing Derivatives SNV Baseline correction |
| Communication and Interfaces |
Bi-directional OPC DA SIPAT (Siemens) SynTQ (Optimal Ltd.) PharmaMV (Perceptive Engineering Ltd.) Process Pulse (Camo) |