Editions Comparison Chart
IMSXpress ISO 13485 (21 CFR 820) Software
 |
|
|
|
|
|
|
|
|
LIGHT
Edition
|
STANDARD
Edition
|
PROFESSIONAL
Edition
|
|
|
|
Validation and 21 CFR Part 11 compliance |
|
|
|
|
|
|
Formal validation |
 |
|
|
|
|
|
Full 21 CFR Part 11 compliance (Electronic Signatures and Electronic Records regulation) |
|
|
|
|
|
|
Users and Access |
|
|
|
|
|
|
Multiple admin and full log-in users (3 included with purchase and SaaS subscription) |
|
|
|
|
|
|
Set up remote access from anywhere (over internet):
You can set up your own remote access, use our cloud-based data hosting service,
or get the on-line subscription package |
|
|
|
|
|
|
Data hosting service (cloud MS SQL Server)
|
NA |
Optional
|
Optional
|
|
|
|
Terminal Server and Remote Desktop deployment
|
|
|
|
|
|
|
Document Distribution |
|
|
|
|
|
|
Document folder tree menu |
|
|
|
|
|
|
Auto generated headers/footers |
|
|
|
|
|
|
Document attachments |
|
|
|
|
|
|
Document viewing permissions |
|
|
|
|
|
|
Automated document training |
|
|
|
|
|
|
Document Control |
|
|
|
|
|
|
Multiple revisions |
|
|
|
|
|
|
Revision approval and release |
|
|
|
|
|
|
Sealing of approved/released revisions |
|
|
|
|
|
|
Revision status (Active, Draft, Archive) |
|
|
|
|
|
|
Document reading and editing permissions |
|
|
|
|
|
|
Automated document training |
|
|
|
|
|
|
Revision approval request process (incl. emailing, attachments, etc.) |
|
|
|
|
|
|
Document approval management (for Document Control admins) |
|
|
|
|
|
|
Part 11 compliant electronic signatures |
|
|
|
|
|
|
ISO Modules |
|
|
|
|
|
|
Overview and record-level reports |
|
|
|
|
|
|
Training module and employee training accounts (training centers) |
|
|
|
|
|
|
Part 11 compliant electronic signatures (for approving and closing out records) |
|
|
|
|
|
|
Data Filtering and Export |
|
|
|
|
|
|
Data filtering |
|
|
|
|
|
|
Data export to Excel (for charting, statistics, etc.) |
|
|
|
|
|
|
Alerts and Notifications |
|
|
|
|
|
|
Record status alerts (due, past-due, days left, etc.) |
|
|
|
|
|
|
Record status reports |
|
|
|
|
|
|
Tasking |
|
|
|
|
|
|
Tasking process (incl. emailing, attachments, etc.) |
|
|
|
|
|
|
Tasking management (for module administrators) |
|
|
|
|
|
|
Messaging and Emailing |
|
|
|
|
|
|
Internal messaging system |
|
|
|
|
|
|
Emailing messages to external email |
|
|
|
|
|
|
Security, permissions and electronic signatures |
|
|
|
|
|
|
Password security policies |
|
|
|
|
|
|
User access, edit and read permissions |
|
|
|
|
|
|
Prmissions management by groups |
|
|
|
|
|
|
Electronic signatures (Part 11 compliant) |
|
|
|
|
|
|
Data Import |
|
|
|
|
|
|
Bulk import documents (into Document Control module) |
|
|
|
|
|
|
Bulk import personnel (into Training module) |
|
|
|
|
|
|
Bulk import suppliers (into Supplier Control module) |
|
|
|
|
|
|
Bulk import measuring equipment (into Measuring Equipment module) |
|
|
|
|
|
Bulk import operations equipment (into Preventive Maintenance module) |
|
|
|