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ISO 13485:2016 & 21 CFR 820 (Medical) Software

Document Control and Quality System Management Software

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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

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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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FEATURES (vary by edition)

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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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4-product bundle with all you need to implement ISO 13485 and/or FDA QSR

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  • 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

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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)

>>More Information[/vc_column_text][/vc_tta_section][vc_tta_section title=”Item 3 – Internal Audit and Gap Analysis Checklist” tab_id=”1581928243349-533ead45-e6db”][vc_column_text]

  • 30-page MS Word checklist with integrated internal auditor guide
  • Covers both ISO 13485:2016 and 21 CFR Part 820

>>More Information[/vc_column_text][/vc_tta_section][vc_tta_section title=”Item 4 – Employee Training – Self-study Course for Personnel” tab_id=”1581928365050-9791e0a4-2bcd”][vc_column_text]

  • 24-page training booklet
  • Multiple choice test
  • Certificate of completion

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