Nanosight Launches the CFR21 Part 11 Compliant Version of Their Nanoparticle Characterization Software
CFR 21 Part 11 is the part of the CFR21 guidelines issued by the FDA related to electronic record keeping and is primarily aimed at the pharmaceutical industry. It pertains to a number of requirements for scientific instruments such as requiring that there are suitable levels of access for different user and manager levels within the organization, that records are stored in a protected way, and that data, if changed, should not replace or obscure the original data, and that the software has been developed in a responsible and reliable manner amongst others.
Speaking on this exciting news, NanoSight’s Head of Development, Dr Patrick Hole, said, “In the last year or so, our software has reached a level of maturity that with the April release of the latest version of NTA (Nanoparticle Tracking Analysis), implementation of the CFR21 part 11 was readily achievable and timely. The software was already aligning towards a level of robustness required across all industries and this, coupled with the requirement from several of our industry customers to implement these changes, made it an important and natural extension to the software. This extension will allow these users and others in the field to move forward further with their use of the technology.”
At the recent Protein Stability Conference held in Breckenridge, Colorado, senior FDA members broadly welcomed the growing appreciation of the emergence of the NTA technology onto the scene as a contributing technique in the characterization of levels of protein aggregation.
This implementation has been accelerated by the use of a customisable off-the-shelf CFR21 part 11 toolkit supplied by Process Analysis and Automation Ltd. Mike Collins, PAA, commented “PAA have a strong track record in precisely this field and we were happy to help NanoSight with bringing about this implementation”. The software was readily integrated into NanoSight’s existing NTA and automates many of the CFR requirements including all the user rights management and the digital signing and encryption of records.
CEO Jeremy Warren comments “CRF21 Part 11 compliance is a well-trodden path for analytical instrumentation in QA within Pharma; for us the timing is perfect, as we are introducing this just as customers are beginning to ask for it”.
This follows on swiftly from the company’s achievement in becoming ISO9001 certified last month and further demonstrates the ability of the company to rapidly adopt development and compliance.
To find out more about this implementation of the software and to see examples of it, please visit the company’s web site. Also to learn more about particle characterization using NanoSight’s unique nanoparticle tracking analysis solutions, visit the company website (www.nanosight.com) and register to receive the next issue of NanoTrail, the company’s electronic newsletter.
About NanoSight
NanoSight delivers the world’s most versatile and proven multi-parameter nanoparticle analysis in a single instrument.
NanoSight’s “Nanoparticle Tracking Analysis” (NTA) detects and visualizes populations of nanoparticles in liquids down to 10nm, dependent on material, and measures the size of each particle from direct observations of diffusion. Particle size, concentration, Zeta potential and aggregation can all be analyzed while a fluorescence mode provides differentiation of labelled particles. This particle-by-particle methodology goes beyond traditional light scattering and other ensemble techniques in providing high-resolution particle size distributions.
NanoSight’s comprehensive characterization matches the demands of complex biological systems, hence its wide application in development of drug delivery systems, of viral vaccines, in nanotoxicology and in biodiagnostics. This real-time data gives insight into the kinetics of protein aggregation and other time-dependent phenomena in a qualitative and quantitative manner.
NanoSight has a growing role in biodiagnostics, being proven in detection and speciation of nanovesicles (exosomes) and microvesicles. As functionalized nanoparticles increasingly fulfill their potential in biodiagnostics, NanoSight is ever more the analytical platform of choice.
NanoSight demonstrates worldwide success through rapid adoption of NTA, having installed more than 300 systems worldwide with users including BASF, GlaxoSmithKline, Merck, Novartis, Pfizer, Proctor and Gamble, Roche and Unilever together with the most eminent universities and research institutes. In addition to this user base more than 250 third party papers citing NanoSight results consolidate NanoSight’s leadership position in nanoparticle characterization. For more information, visit the NanoSight website (www.nanosight.com).
About PAA
Process Analysis & Automation Ltd (PAA) work with pharmaceutical, biotechnology and healthcare organisations to significantly increase sample throughput and data accuracy of sample preparation and analysis. PAA manufacture and supply automated workcells, proprietary laboratory automation scheduling software (Overlord) and other equipment to facilitate this. Overlord, incorporates drivers for over 400 of the most widely used instruments and robots.
For further information
Please contact NanoSight direct or their marketing agency, NetDyaLog Limited:
NanoSight Limited
Minton Park
London Road
Amesbury SP4 7RT
T +44 (0) 1980 676060
F +44 (0) 1980 624703
NanoSight website
jeremy.warren@nanosight.com
NetDyaLog Limited
39 de Bohun Court
Saffron Walden
Essex CB10 2BA
T +44 (0) 1799 521881
M +44 (0) 7843 012997
NetDyaLog website
jezz@netdyalog.com