Quick Tour Slide Show and Trial Software
Everything You Need to Jump-start Your ISO 13485 Project
As soon as you install the software most of your new quality system is automatically
implemented. You can immediately start editing and controlling your documents, initiate
corrective actions, process customer complaints, and so forth. The only work left
is to customize the manual and procedures, and start running the system.
A Platform for Part 11 Paperless Management of Your Quality System
After you implement (and certify) your ISO 13485 system, the ISOXpress software
will continue serving you as a platform for paperless document control and day-to-day
management of your quality system. ISOXpress Professional edition features electronic
signatures and fully complies with Part 11
MDR/Vigilance and CAPA system compliant with 21 CFR 803 and MedDev 2.12.1
ISOXpress software includes Complaints, NC Product and CAPA modules compliant with
FDA Medical Device Reporting (21 CFR 803), Euripean Medical Device Vigilance (MEDDEV
2.12.1), as well as Canadaian and Australian MD Vigilance requirements.
There is Plenty of Help
This software package can be easily implemented without any prior experience with
ISO 13485 quality systems. Everything you need to learn and know is included in
ISOXpress software Help consists of tutorials (slide shows) showing how everything
is done. For example, how to set up new users and assign permissions, how to manage
and control documents, how to plan and monitor internal audits, how to generate
reports, and so forth.
- The Template Manual and Procedures have plenty of embedded tips
and notes to help you edit and customize the documents to fit your company. It is
like having a consultant by your side, anticipating your questions and helping as
you go along.
- The Internal Audit and Gap Analysis Checklist includes an integrated
auditing tutorial — an additional column, "What to look for and how", with tips
and instructions for the auditor.
- The Employee Training Booklets provide basic information and
an overview of how the ISO 13485 quality system works.