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IMSXpress ISO 13485:2016 & 21 CFR 820 Software
Document Control and Quality System Management Software
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13 Modules
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- Document Control (w/ training)
- Document Distribution (Library)
- Complaints
- Corrective/Preventive Action (CAPA)
- Internal Audit
- Nonconforming Product
- Risk Management
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- Automated Training with
Document Training integration
- Management Review
- Supplier Control
- Preventive Maintenance
- Measuring Equipment
- Change Control
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Normative compliance
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- 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 Certificate
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- Electronic signatures (Part 11)
- Document approval process
- Document distribution module
- Due/Past due record alerts
- Tasking
- Messaging and emailing
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- Data filtering and export
- Bulk data import
- User and group permissions
- Password security policies
- Audit trail (Part 11)
- Remote connectivity
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