Since 1992, AQA's ISO systems have been implemented and certified in thousands of companies
ISOXpress Software:
ISO 13485 & 21 CFR 820 Document
Control and QMS Management Software
Formally Validated  (more info)
21 CFR Part 11 compliant  (more info)
10 Modules cover ISO 13485 and 21 CFR Part 820, FDA MDR (Part 803), and European, Canadian and Australian Vigilance.
Completely Paperless quality system
Electronic Signatures enhance security and compliance with regulatory requirements
Tasking, Alerts, E-mailing and other communication and collaboration features
Preloaded FREE ISO 13485 Starter Package with manual, procedures, checklists, training materials, etc. (more info)
      
3 Editions:      
Light
Standard
Professional (Part 11 compl.)
2 Purchase Options:   
Local Install: Purchase and install
on your own computers/servers
   
On-line: Subscribe to a hosted,
on-line system
FREE technical support and updates
More Information    Editions & Features Chart    Pricing
ISO 13485 & 21 CFR 820
Complete Starter Package
All you need to implement ISO 13485
and comply with 21 CFR Part 820/803
      
3 Editions:      
Light
Standard
Professional (Part 11 compl.)
2 Purchase Options:   
Local Install: Purchase and install
on your own computers/servers
   
On-line: Subscribe to a hosted,
on-line system
FREE technical support and updates
More Information    Editions & Features Chart    Pricing