NanoSight Launches the CFR21 Part 11 Compliant Version of their Nanoparticle Characterization Software
Product News Sep 06, 2011
NanoSight, has announced that they have developed their NTA (Nanoparticle Tracking Analysis) software platform such that it may now be implemented within a CFR compliant environment.
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 customizable 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.