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ISO 13485:2016 & 21 CFR 820 SaaS Subscription Software
ISO 13485 & 21 CFR 820 Complete Software with all 15 Modules
Software with complete set of 15 modules: Document Library, Forms & Records, Document Control, Training, Change Control, Risk Management, Complaints, CAPAs, NC Product,
Products, Internal Audits, Management Reviews, Supplier Control, Mesuring Equipment, Preventive Maintenance
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Billing Cycle |
Standard
Edition |
Professional
Edition |
| ISO 13485 & 21 CFR 820 IMSXpress software with 15 modules. Incl. 3 Full users and cloud database hosting. |
Annual |
$2,500/year |
$3,300/year |
| Monthly |
$250/month |
$330/month |
Pre-loaded ISO 13485:2016 & 21 CFR 820 template documentation:
Quality Manual and 40 Operational Procedures.
Forms are embedded in the software, so no 'paper' forms are included. This item is nonrefundable. |
$760 (one-time-payment) |
| ISO 13485:2016 & 21 CFR 820 Internal Audit Checklist (can also use for Gap Analysis). |
$110 (one-time-payment) |
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SaaS Subscription Additional Users
Discounts available for 10 or more Full, Basic or Offline Trainee licenses
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Software Validation Report Package
The validation report package includes Validation Plan, Full Validation Report (about 600 pages), Software Release Notice, and Software Validation procedure. The documents are updated for new software versions.
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Software Validation Report Package: Validation Plan, Final Validation Report (over 600 pages), Software Release Notice, Software Validation operational procedure
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Annual |
$760/year |
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Upgrade Add-On Modules (for existing systems)
For systems that were purchased before these new modules existed
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Billing Cycle |
Standard
Edition |
Professional
Edition |
Training module:
Fully automated training system with self e-training, integrated document training, job descriptions, and more (Full, Basic or Offline Trainee license is required for each trainee) |
Annual |
$450/year |
$550/year |
| Monthly |
$45/month |
$55/month |
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Change Control module:
Use for document, engineering, and process
changes. Fully integrated with Doc Control module. |
Annual |
$450/year |
$550/year |
| Monthly |
$45/month |
$55/month |
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Risk Management module:
Use for ISO 14971 device risk management
and to manage QMS related risks. |
Annual |
$450/year |
$550/year |
| Monthly |
$45/month |
$55/month |
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Forms/Records module:
Use for making fillable PDF form templates, and for filling the forms with data and creating records. |
Annual |
$450/year |
$550/year |
| Monthly |
$45/month |
$55/month |
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Preventive Maintenance module:
Use for scheduling and administrating maintenance,
and for managing spare parts inventory. |
Annual |
$450/year |
$550/year |
| Monthly |
$45/month |
$55/month |
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Products module:
For each product (device) track changes, CPAs, complaints, nonconformities, risk management, audit findings, and supplier nonconformities. |
Annual |
$450/year |
$550/year |
| Monthly |
$45/month |
$55/month |
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If you require a quote, please contact us by phone +1 626 796 9000 or email cs@imsxp.com
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For the Purchase-To-Own option go to the PTO store.
SaaS Subscription includes:
- SQL database cloud hosting
- Online access from anywhere
- Unlimited maintenance and technical
support
The differences between the Standard and Professional editions are shown in the Feature Chart.
The template documentation package
and the internal audit checklist are billed only once on initial purchase. They are not refundable.
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