 |
|
|
IMSXpress ISO 13485:2016 & 21 CFR 820 Software
Document Control and Quality System Management Software
|
|
15 Modules
|
- Document Library
- Document Control
- Forms and Records
- Training
- Change Control
- Risk Management
- Complaints
- CAPAs
|
- Internal Audit
- Nonconforming Product
- Management Review
- Supplier Control
- Preventive Maintenance
- Measuring Equipment
- Products
|
|
Normative compliance
|
- Software complies with ISO 13485:2016 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 report available as optional add-on subscription) >>Validation Certificate
|
|
|
- Electronic signatures (Part 11)
- Document approval process
- Document distribution module
- Due/Past due record alerts
- Tasking
- Messaging and emailing
- Data search, filtering and sorting
|
- Data export to Excel
- Bulk data import
- User and group permissions
- Password security policies
- Audit trail (Part 11)
- Remote connectivity
- Full Validation report
|
|
Optional Add-On QMS Template Documentation
|
- Covers both ISO 13485:2016 and 21 CFR Part 820
- Quality Manual
- 39 Operational Procedures
- All template documents are pre-loaded into the IMSXpress software
Note: There are no 'paper' forms in the documentation package. All forms are integrated into the IMSXpress software as electronic data entry screens.
|
|
Optional Add-On Internal Audit Checklist
|
- 30-page MS Word checklist with integrated internal auditor
guide
- Covers both ISO 13485:2016 and 21 CFR Part
820
- You can also use it as Gap Analysis checklist
|
|
Optional Add-On Software Validation Report
|
- Validation Plan
- Full Validation Report (over 600 pages)
- Software Release Notice
- Software Validation operational procedure
Note: The report is updated fo every new software version (excluding hot fixes).
|