FEATURES | BUSINESS EDITION | IMS UPGRADE | ENTERPRISE EDITION |
---|---|---|---|
# of Licenses Included with Purchase | 1 Primary | N/A | 25 Primary, 250 Secondary |
Max # of Licenses that can be used with Edition | Up to 25 Primary, 250 Secondary | N/A | Unlimited |
# of Production Databases Included with Purchase | 1* | N/A | 4* |
Modules Included With Edition | BUSINESS EDITION | IMS UPGRADE | ENTERPRISE EDITION |
LaunchPad | 1 | 1 | 1 |
Corrective & Preventative Action (CA/PA) | 1 | 1 | 1 |
Administration | 1 | 1 | 1 |
Documents | 1 | 1 | 1 |
Audits | 1 | 1 | 1 |
Assets | 1 | 1 | 1 |
People | 1 | 1 | 1 |
Training | 1 | 1 | 1 |
Customers | 1 | 1 | 1 |
Suppliers | 1 | 1 | 1 |
Workload | 1 | 1 | 1 |
CA/PA Analysis | 1 | 1 | 1 |
Incident Analysis | 1 | 1 | |
Occurrences (Forms) | 1 | 1 | |
Incidents | 1 | 1 | |
Additional Included Features | Q-PULSE BUSINESS EDITION | Q-PULSE IMS UPGRADE | Q-PULSE ENTERPRISE EDITION |
Document Retrieval Service (DRS) | 1 | 1 | 1 |
Web Portal | 1 | 1 | 1 |
Mobile Apps (iOS & Android Compatible) | 1 | 1 | 1 |
Application Programming Interface (APIs) | 1 | 1 | 1 |
Add-Ons that may be Purchased for Edition: | Q-PULSE BUSINESS EDITION | Q-PULSE IMS UPGRADE | Q-PULSE ENTERPRISE EDITION |
21 CFR Part 11 Functionality** | May be Purchased | May be Purchased | Included |
ECL2 Q-Pulse Validation Support Pack*** | May be Purchased | May be Purchased | May be Purchased |
*# of Production Database(s) & 1 Training Database included
** 21 CFR Part 11 Functionality includes: Audit Log Viewer (independent of application), Auto Log Off, Intruder Lock Out, Strong Passwords, Electronic Signatures (already included in all editions), Developer Support of Validation Document, Available and Executed Test Cases, Certificate of Conformity
*** ECL2 Q-Pulse Validation Support Pack includes: (CSVP) Computerized System Validation Plan, “Getting Started” document, SOP-Validation of Computerized Systems, SOP-Risk Assessment & Mitigation, (CRS) Configuration Specification, (IQ)Installation Qualification Protocol, (FRS) Functional Requirement Specification, (OQ) Operational Qualification Protocol, “Organizing the URS & PQ” document, (URS) User Requirements Specification Example, (PQ) Performance QualificationProtocol Example, Traceability Matrix, Final Report & Release Memo Template, Table of Contents, Appendix J-Audit Log