ISO 13485:2016 & 21 CFR 820 (Medical) Software
Document Control and Quality System Management Software
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) - 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
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
FEATURES (vary by edition)
- 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
ISO 13485:2016 & 21 CFR 820 Complete Starter Package
4-product bundle with all you need to implement ISO 13485 and/or FDA QSR
- 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) Formally validated to FDA, ISO and IEC requirements
- Quality Manual
- 39 Operational Procedures
- 42 Forms (35 electronic and 7 manual)
- All template documents are pre-loaded into the software (item 1)
- 30-page MS Word checklist with integrated internal auditor guide
- Covers both ISO 13485:2016 and 21 CFR Part 820
- 24-page training booklet
- Multiple choice test
- Certificate of completion