Nexygen Plus 4.18
is a flexible, easy-to-use materials testing software that comes with an optional Advanced Security module.
This module is specifically developed to assist medical device and pharmaceutical organizations worldwide in complying with FDA 21 CFR Part 11 and similar, critical international standards.
When combining the NexygenPlus Advanced Security module with a materials tester from the LS PLUS or LD Series, organizations get a complete solution that can be integrated into their Active Directory (AD). Audit trail data is stored in a secure SQL database where Admin users can find extensive logs containing information including:
- Timestamps
- User IDs
- Computer name
- Changes to machine setup
- Machine error events
- Changes including old and new values
- Printing of reports
- User authentication
NexygenPlus allows the operator to control and monitor all aspects of the system from a single front end, ensuring fast, reliable and powerful testing and data analysis for a variety of test types such as tensile, compression, peeling, tearing, creep, relaxation, and flexural tests. The user interface is intuitive and resembles the Microsoft Office user interface for ease of use.
Getting started with NexygenPlus is simple thanks to the extensive built-in library of test methods that all adhere to AACC, ASTM, DIN, EN, ISO, and other international standards. You can also choose to create custom multi-stage tests for more complex or unique test demands.
Entire tests can be videoed and synchronized with the stress/strain data and replayed for detailed post-test analysis.
A superviser can set the level of access for users and prevent unauthorized access. An optional IQ/OQ package that includes test result calculation verification is available. A certificate is provided upon completion.
As NexygenPlus interacts with Excel and Word, test results can automatically be transferred directly into an organization’s own templates. A simple-to-use report designer is linked to Excel and Word, enabling all layout, fonts, and images to be manipulated in the full power of these programs.
NexygenPlus and its optional Advanced Security module can be purchased as an upgrade to older versions of NexygenPlus, or as part of a complete solution including IQ/OQ and result calculation verification.
NexygenPlus Advanced Security Module Key Features:
- Assist in adherence to FDA 21 CFR Part 11
- Easy to use
- Complete standards library for pharmaceutical and medical device testing
- Comprehensive multi-stage test wizard
- Export data directly into your Excel and Word templates
Per maggiori informazioni vedere anche:
- Article about FDA 21 CFR Part 11 adherence
- Landing page about FDA 21 adherence
- Press release for pharma/medical device industry
- Video
