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QUALITY DOCUMENTS

General

e•noval documents

E-noval – Software Brochure (PDF document)

E-noval 4.0 – Validation Certificate (PDF document)

E-noval 4.0 – 21 CFR Part 11 Form (PDF document)

E-noval 4.0 – Security and Confidentiality Form (PDF document)

E-noval 4.0 – Quick Start Guide (PDF document)

Excel template

E-noval template (Excel document)

Sample datasets

Bioanalytical method (Excel document)

API method (Excel document)

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

Stab•e•lity documents

Stabelity – Software Brochure (PDF document)

Stabelity 3.2 – Validation Certificate (PDF document)

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

Stabelity 3.0 – Security & Confidentiality Form (PDF document)

Excel template

Long-term shelf-life (Excel document)

Accelerated testing (Excel document)

Commercial (OOT-OOS) stability (Excel document)

Sample datasets

Long-term shelf-life (Excel document)

Accelerated testing (Excel document)

Commercial (OOT-OOS) stability (Excel document)

Seelva documents

Seelva – Software Brochure (PDF document)

Seelva 2.1 – Validation Certificate (PDF document)

Seelva 2.1 – 21 CFR Part 11 Form (PDF document)

Seelva 2.1 – Security & Confidentiality Form (PDF document)

Seelva 2.1 – Content Quick Start Guide (PDF document)

Seelva 2.1 – Potency Quick Start Guide (PDF document)

Excel template

Content assay (Excel document)

Potency (Excel document)

Sample datasets

Content assay (Excel document)

Potency (Excel document)

Transval documents

Transval 2.0 – Validation Certificate (PDF document)

Transval 2.0 – 21 CFR Part 11 Form (PDF document)

Transval 2.0 – Security & Confidentiality Form (PDF document)

Transval 2.0 – Quick Start Guide (PDF document)

Excel template

Sample Transfer (Excel document)

Sample dataset

Sample Transfer (Excel document)