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Blog Articles

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FDA 21 CFR Part 11 vs. EU Annex 11

Maria Anastasia Zormpa

FDA 21 CFR Part 11 vs. EU Annex 11: Key Requirements and Differences

21 CFR Part 11

FDA 21 CFR Part 11 Open vs. Closed System

Desiree Tarranco

21 CFR Part 11 Open vs. Closed System: Examples, Controls, and Key Differences

21 CFR Part 11

FDA 21 CFR Part 11 Audit Trail Requirements

Blagica Ingilizovska

FDA 21 CFR Part 11 Audit Trails: Definition, Requirements, and Compliance

21 CFR Part 11

FDA 21 CFR Part 11 Password Requirements

Maria Anastasia Zormpa

FDA 21 CFR Part 11 Password Requirements

21 CFR Part 11

FDA 21 CFR Part 11 Applicability Assessment

Maria Anastasia Zormpa

FDA 21 CFR Part 11 Applicability Assessment: Definition, Steps, and Compliance

21 CFR Part 11

FDA 21 CFR Part 11 Compliance Checklist

Desiree Tarranco

21 CFR Part 11 Compliance Checklist [PDF & XLS Download]

21 CFR Part 11

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QMS Templates

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QMS Software Comparison Template Featured Image

QMS Software Comparison Template

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CAPA Form Template Featured Image

CAPA Form Template

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Non-Conformance Report Template Featured Image

Non Conformance Report Template

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Data Sheets

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SimplerQMS CAPA Management Data Sheet Preview

SimplerQMS Training Management Data Sheet

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SimplerQMS CAPA Management Data Sheet Preview

SimplerQMS CAPA Management Data Sheet

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SimplerQMS Document Control Data Sheet Preview

SimplerQMS Document Control Data Sheet

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Customer Case Studies

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Pharmaceutical CDMO

Basic Pharma

Basic Pharma changed its way of working, allowing employees to focus on quality instead of administrative tasks.

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Pharmaceutical CRO/CDMO

Minerva Imaging

Minerva Imaging accelerated the employee onboarding and training processes by 50% with SimplerQMS.

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Medical Devices

LiNa Medical

LiNA Medical improved the efficiency of managing regulatory and quality documentation and R&D processes.

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Product Tours

SimplerQMS Product Tour

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Document control

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Training Management

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Analytics (Overview)

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Analytics

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Change Control

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Document Control (AI-Powered)

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Generate Summary (AI-Powered)

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Periodic Reviews

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