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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 |
$2,750/year |
$3,630/year |
| Monthly |
$275/month |
$363/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. |
$890 (one-time-payment) |
| ISO 13485:2016 & 21 CFR 820 Internal Audit Checklist (can also use for Gap Analysis). This item is nonrefundable. |
$210 (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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Billing Cycle |
Standard
Edition |
Professional
Edition |
Additional Full User account
(You can change quantity in the shopping cart)
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Annual |
$420/year |
$540/year |
| Monthly |
$42/month |
$54/month |
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Additional Basic User account
(You can change quantity in the shopping cart) |
Annual |
$210/year |
$270/year |
| Monthly |
$21/month |
$27/month |
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Additional Offline Trainee
account
(You can change quantity in the shopping cart)
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Annual |
$70/year |
$90/year |
| Monthly |
$7/month |
$9/month |
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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 |
$830/year |
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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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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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