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

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) Formally validated to FDA, ISO and IEC requirements