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Documents

Quality Documents:

General

Incident Report Form (to print, fill and sign before sending to info@arlenda.com)

Change Request Form (to print, fill and sign before sending to info@arlenda.com)

E-noval

Brochure (English - French - Chinese) | Quick-Start | User Guide

E-noval 3.0 - Factory Release Form (PDF document)

E-noval 3.0 - 21 CFR Part 11 Form (PDF document)

E-noval 3.0 - Security and Confidentiality Form (PDF document)

Sample dataset(s) for E-noval

Bioanalytical method (Excel document)

API method (Excel document)

Chromium in Water (ICP-MS) (Excel document)

Stabelity

Stabelity 3.2 - Factory Release Form (PDF document)

Stabelity 3.1 - User Guide

Stabelity 3.1 - Factory Release Form (PDF document)

Stabelity 3.0 - Factory Release Form (PDF document)

Stabelity 3.0 - 21 CFR Part 11 Form (PDF document)

Stabelity 3.0 - Security & Confidentiality Form (PDF document)

Sample dataset(s) for Stab.e.lity

Long-term shelf-life (Excel document)

Accelerated testing (Excel document)

Commercial (OOT-OOS) stability (Excel document)

Seelva

Brochure (English - French - Chinese) | User Guide

Quick Start Guides: Content | Potency (Coming soon ...)

Seelva 2.0 - Factory Release Form (PDF document)

Seelva 2.0 - 21 CFR Part 11 Form (PDF document)

Seelva 2.0 - Security & Confidentiality Form (PDF document)

Sample dataset(s) for Seelva

Content assay (Excel document)

Potency (Excel document)

Transval

Brochure (English) | User Guide

Transval 1.1 - Factory Release Form (PDF document)

Transval 1.1 - 21 CFR Part 11 Form (PDF document)

Transval 1.1 - Security & Confidentiality Form (PDF document)

Sample dataset(s) for Transval

Sample Transfer (Excel document)