21 CFR Part 11 Compliance
Particle Measuring Systems has been involved with meeting 21 CFR Part 11 since its introduction in 1997. Please read below the papers on our current compliance to the legislation relating to Electronic Signatures and Electronic Records (ESER).
Papers
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Particle Measuring Systems' Software and GAMP® 21 CFR Part 11 Compliance (92.9 KB) Pharmaceutical companies have historically submitted product applications to the Food and Drug Administration (FDA) on paper. With the advent of technology this is now dominated with electronic data records and electronic submissions. This change in philosophy has meant that in the FDA's... Download above file for full tables and figures, or for overview, see HTML Version. |
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FDA Paper Review on 21 CFR Part 11 (580.3 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
Products
Facility monitoring software that helps you meet your cGMP requirements, providing simplified validation and compliance to 21 CFR Part 11. Helps you to analyze data from your particle counters.
Provides a comprehensive view of batch-based liquid particle counter information with histogram, time plot, and tabular data.
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When a full microbial monitoring application is required, the AirCapt MP8 (an integrated PLC controller with SCADA interface and capability of running up to eight remote heads) can be used. This interface fully integrates into standard FMS software and is designed for compatibility with the next generation FacilityNet particle monitoring software. Expansion of the base module allows a second multiple of eight sensor heads to be added to a single PLC controller.
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The MiniCapt portable microbial air sampler allows the user to move the unit around the clean area to collect microbiological particle samples and replicates the Lasair® particle counter range of products in application. There are two accessories: a compressed gas kit for sampling high-pressure process gases and an isolator kit for remote sampling applications.
Services
Information on this website is subject to change without notice.
