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Guides & tools

Find relevant templates, guides, and other quality-related tools to ease your day-to-day work

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Computer System Validation Template

Validate any software and make sure it meets all your usage and regulatory requirements.

Download CSV Template  

Equipment Management Template

Manage all tasks related to equipment: qualification, verification, calibration, and overall maintenance.

Download Equipment Management Template  

Skills Matrix Template

Build your own skills matrix to define the required skills for a specific project or team.

Download Skills Matrix Template  

Complete Training Matrix Toolkit

Plan and manage your company training without skipping any important subject in the process.

Download Training Matrix Tool  

Standard Operating Procedure (SOP) template

Provide step-by-step instructions on how to perform tasks at your company.

Download SOP Template  

Work Instructions Template

Outline specific assignments and steps of broader processes and procedures.

Download Work Instructions Template  

5 Whys Template

Analyze and understand the cause of a problem using the 5 Whys technique.

Download 5 Whys Template  

Root Cause Analysis Template

Find the root cause of a problem and identify possible solutions by reviewing underlying issues.

Download Root Cause Analysis Template  

Quality Manual Template

Define the quality management system of your organization and how it should function.

Download Quality Manual Template  


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GMP Annex 1 Guide

Discover the main changes and updates you need to take into account regarding the manufacture of sterile medicinal products.

Download GMP Annex 1 Guide  

How to Respond to FDA Warning Letters

Learn the eight steps of how to successfully respond to an FDA warning letter.

Download Warning Letter Response Template  

GAMP 5 vs GAMP 5 2nd Edition

Get a complete overview of what has changed in this second edition by ISPE.

Download GAMP 5 vs GAMP 5 2nd edition comparison  

8-Step Guide to a Crisp and Clear Non-conformance Report

Nail a non-conformance report, avoid recalls, and legal penalties, and, improve your product quality!

Download Non-conformance Report Template  

Internal Audits Best Practices

Perform an internal audit correctly and foster an organization-wide quality culture.

Download Internal Audits Guide  

Get FDA Drug Approval

Start preparing all your documentation to launch your pharmaceutical product fully compliant on the market.

Download FDA Drug Approval Template  

Lean vs. Six Sigma

Learn the usage of both methodologies and how to get certified.

Download Lean vs. Six Sigma Guide  

Best Quality KPIs to track

Achieve your goals and drive positive change in your organization.

Download Quality KPIs Guide  

Create an Effective CAPA form

Use the 8D approach to plan and build a compliant and efficient Corrective and Preventative Actions (CAPAs) report.

Download CAPA Form Guide  


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EU MDR Checklist Implementation

Do a free assessment of your QMS readiness under EU MDR and ISO 13485:2016.

Download EU MDR Checklist  

Other resources

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Smart Quality Maturity Level Quiz

Get insightful tips on how to improve your organization’s processes and quality culture, and identify areas for improvement.

Download Smart Quality Maturity Quiz  

The 7-step blueprint for Smart Quality transformation

Understand the basics of Smart Quality methodology and execute it in your organization.

Download Smart Quality Transformation Blueprint  
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