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 >> Complete Starter Package >> Item 1: Software
IMSXpress ISO 13485 & 21 CFR 820 Software
Document Control and Quality System Management Software
14 Modules
  • Document Control (w/ training)
  • Document Distribution (Library) 
  • Complaints
  • Corrective/Preventive Action (CAPA)
  • Internal Audit
  • Nonconforming Product
  • Risk Management
  • Automated Training with
    Document Training integration
  • Management Review
  • Supplier Control
  • Preventive Maintenance
  • Measuring Equipment
  • Change Control
Normative compliance
  • Software complies with ISO 13485 and 21 CFR Part 820
  • Electronic signatures/records comply with 21 CFR Part 11
    (Professional Edition only) >>Part 11 Certificate
  • Complaints/CAPA modules comply with 21 CFR Part 803,
    MEDDEV 2.12.1 and MD Vigilance
  • Software formally validated to FDA software validation guidelines,
    21 CFR Part 11, IEC 60601-1, IEC 62304, ISO 14971 >>Validation Certificate
  • Electronic signatures (Part 11)
  • Document approval process
  • Document distribution module
  • Due/Past due record alerts
  • Tasking
  • Messaging and emailing
  • Data filtering and export
  • Bulk data import
  • User and group permissions
  • Password security policies
  • Audit trail (Part 11)
  • Remote connectivity
 
Purchase Options
  • Subscribe: Software as a service (SaaS) with database cloud hosting
  • Purchase to own: install software and database on your own server
>>  Purchase Starter Package
Three editions
  • Light
  • Standard
  • Professional
>> Editions and Feature Chart
Related Information
>> Complete Starter Package >> Part 11 Certificate >> Validation Certificate >> Editions and Feature Chart >> Installation Options
Download Free Trial
Install free trial software on your computer and test it for 30 days.
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Sign up for a Web Presentation
Sign up for a live web presentation of IMSXpress Document Control and QMS Management Software with Complete Starter Package. The web presentation takes about 30 to 45 minutes .
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