AQA Company, Inc.

- Version ISO 13485:2016 & 21 CFR 820 - Complete QMS Starter Package Software

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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

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Item 2 - ISO 13485/FDA QSR Template Documentation
  • Quality Manual
  • 39 Operational Procedures
  • 42 Forms (35 electronic and 7 manual)
  • All template documents are pre-loaded into the software (item 1)

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Item 3 - Internal Audit and Gap Analysis Checklist
  • 30-page MS Word checklist with integrated internal auditor guide
  • Covers both ISO 13485:2016 and 21 CFR Part 820

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Item 4 - Employee Training - Self-study Course for Personnel
  • 24-page training booklet
  • Multiple choice test
  • Certificate of completion

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  • Subscribe: Software as a service (SaaS) with database cloud hosting
  • Purchase to own: install software and database on your own server

  • Subscribe: Software as a service (SaaS) with database cloud hosting
  • Purchase to own: install software and database on your own server

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