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21 CFR 11 Compliant Software
Pharmaceutical Net and SamplerSight-Pharma satisfy pharmaceutical regulations
(295.1 KB)
Software Features Include
Secure System Audit Trails
Unique User Names and Passwords
Encrypted Data
Ease of Validation
Software Validation Notebook
Pharmaceutical Net Software
Pharmaceutical Net and 21CFR11
(99.0 KB)
Facility Monitoring software
Data Acquisition and Reporting
SamplerSight-Pharma Software
Parenteral Sampling Software
Small and large volume parenteral systems
Testing to USP <788>
Aerosol/Cleanroom Monitoring
LASAIR II 550L
aerosol particle counter in 50 LPM
HandiLaz Mini
handheld airborne particle counter 0.1 cfm
Airnet
system integration sensor
Validation
System installation
Full validation documentation
Onsite system testing to GMP regulations
Application Notes:
Particle Measuring Systems Software & 21 CFR Part 11 Compliance
(315.9 KB)
Particle Monitoring Requirements in Pharmaceutical Cleanrooms
(758.0 KB)
Particle Counting in Parenteral Solutions
(176.0 KB)
Technical Document Review: GAMP Good Practices Guide, Calibration Management
(156.7 KB)
Technical Document Review: Good Automated Manufacturing Practices, GAMP Guide 4 - December 2001
(182.5 KB)
Technical Document Review: February 2003 FDA Guidance for Industry note
(127.5 KB)
Without Measurement There Is No Control
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