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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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Templates

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Computer System Validation Template

Computer System Validation Template

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

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Equipment Management Template

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

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Skills Matrix Template

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

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Complete Training Matrix Toolkit

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

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Standard Operating Procedure (SOP) template

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

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Work Instructions Template

Outline specific assignments and steps of broader processes and procedures.

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5 Whys Template

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

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Root Cause Analysis Template

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

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Quality Manual Template

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

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Guides

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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.

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How to Respond to FDA Warning Letters

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

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GAMP 5 vs GAMP 5 2nd Edition

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

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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!

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Internal Audits Best Practices

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

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Get FDA Drug Approval

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

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Lean vs. Six Sigma

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

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Best Quality KPIs to track

Achieve your goals and drive positive change in your organization.

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Create an Effective CAPA form

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

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Checklists

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EU MDR Checklist Implementation

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

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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.

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The 7-step blueprint for Smart Quality transformation

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

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