Guides and tools

Guide

How to Prepare for GMP Annex 1 Guide

EU GMP Annex 1 will come into force in less than six months. Are you prepared for it? Discover the main changes and updates you need to take into account regarding the manufacture of sterile medicinal products. 

Guide

How to Respond to FDA Warning Letters

FDA warning letters are critical events for pharmaceutical companies. Download our proven guideline now to learn the eight steps of how to successfully respond to an FDA warning letter!

Guide

GAMP 5 vs
GAMP 5 2nd Edition Guideline

The latest Life Sciences innovations and technological advancements pushed ISPE to adjust to these trending topics and update the GAMP 5 Guide. Get a complete overview of what has changed in this second edition! 

Quiz

Smart Quality Maturity Level Quiz

Find out how far you are in the Smart Quality transformation journey! Get insightful tips on how to improve your organization’s processes and quality culture, and identify areas of improvement. 

Template

Computer System Validation Template

Use our comprehensive template to validate any software and make sure it meets all your usage and regulatory requirements!

Guide

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

Use our guidelines to learn how to nail a non-conformance report and avoid recalls, and legal penalties, and ultimately, improve your product quality! 

Guide

Internal Audits Best Practices Guideline

Use our guidelines to learn how to perform an internal audit correctly and foster an organization-wide quality culture.

Template

Equipment Management Template

Use our template to manage all the tasks related to the equipment: qualification, verification, calibration, and the overall maintenance. 

Guide

How to Get FDA Drug Approval

Download our guideline and start preparing all your documentation to launch your pharmaceutical product in the market fully compliant! 

Template

Skills Matrix Template

Use our template and build your own skills matrix to define the required skills for a specific project or team!

Guide

Complete Guide: Lean vs Six Sigma

Learn the usage of  the methodologies  Lean and Six Sigma,  apart and together, and why and how  get certified.

Guide

Guide: The Best Quality KPIs to track

Achieve your goals and drive positive change in your organization by setting the best Quality KPIs. Get your Quality KPIs guide today!

Guide

Guide: Create an Effective CAPA form

Learn to use the 8D approach to plan and build a compliant and efficient Corrective and Preventative Actions (CAPAs) report with our guide!

Template

The Complete Training Matrix Toolkit

Plan and manage your company trainings with our template and user guide to keep your team consistent.

Checklist

EU MDR Checklist Implementation

Do a free assessment of your QMS readiness in accordance with EU MDR and ISO 13485:2016, right now.