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