AQA Company, Inc.
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- IMSXpress - Version ISO 13485:2016 & 21 ...
IMSXpress - Model ISO 13485:2016 & 21 CFR 820 - Document Control and Quality System Management Software
Electronic signatures (part 11), document approval process, document distribution module, due/past due record alerts, tasking, messaging and emailing, data filtering and export, bulk data import, user and group permissions, password security policies, audit trail (part 11), remote connectivity.
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13 Modules
- Document Control (w/ training)
- Document Distribution (Library)
- Complaints
- Corrective/Preventive Action (CAPA)
- Internal Audit
- Nonconforming Product
- Risk Management
- Automated Training with
- Document Training integration
- Management Review
- Supplier Control
- Preventive Maintenance
- Measuring Equipment
- Change Control
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 Certificate