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- IMSXpress - Version ISO 13485:2016 & 21 ...
IMSXpress - Model ISO 13485:2016 & 21 CFR 820 - Complete QMS Starter Package Software
4-product bundle with all you need to implement ISO 13485 and/or FDA QSR.
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Item 1 - Document Control and QMS Management Software
13 Modules:
- Document Control
- Document Distribution (Library)
- Complaints
- Corrective/Preventive Action (CAPA)
- Internal Audit
- Nonconforming Product
- Risk Management
- Management Review
- Automated Training
- Supplier Control
- Preventive Maintenance
- Measuring Equipment
- Change Control
Electronic quality management system (QMS) software compliant
with 21 CFR Part 11 (Electronic Records and Electronic Signatures)
with 21 CFR Part 11 (Electronic Records and Electronic Signatures)
Formally validated to FDA, ISO and IEC requirements
Item 2 - ISO 13485/FDA QSR Template Documentation
- Quality Manual
- 39 Operational Procedures
- 42 Forms (35 electronic and 7 manual)
- All template documents are pre-loaded into the software (item 1)
Item 3 - Internal Audit and Gap Analysis Checklist
- 30-page MS Word checklist with integrated internal auditor guide
- Covers both ISO 13485:2016 and 21 CFR Part 820
Item 4 - Employee Training - Self-study Course for Personnel
- 24-page training booklet
- Multiple choice test
- Certificate of completion
- Subscribe: Software as a service (SaaS) with database cloud hosting
- Purchase to own: install software and database on your own server
- Subscribe: Software as a service (SaaS) with database cloud hosting
- Purchase to own: install software and database on your own server