The ZignX Medical is a security system that can be used to add-on GMP functionality on equipment with respect to regulatory demands specified in FDA 21 CFR Part 11 and EU Annex 11.
Based on the ZignX patented technology, ZignX Medical works independently of the system on which it is installed. Thus it can used on existing equipment that is otherwise not compatible with today’s compliance solutions.
ZignX Medical adds a range of GMP security features to the existing system as mentioned below.
Our solutions comply with the quality standards set in the industry, and we produce the necessary documentation and perform qualifications and test in accordance with GAMP4 standards.
ZignX Medical products are divided in two groups:
ZignX Medical standard solution comes in two versions, i.e. Basic and Advanced. They are both of-the-shelf products that can be installed into PCs, adding key regulative requirements to the system.
The standard ZignX Medical are highly suitable for stand-alone automated equipment that requires immediate upgrade on regulative requirements.
Our custom solutions are aimed at individual and complex systems or where unique user requirements are in demand. They cover key compliance functionality for PLCs, SCADA PCs and instruments. Select ZignX Custom in the left menu for more information.
Products
