Guides & tools

Brought to you by Scilife, experts in life sciences compliance, this guide breaks down everything you need to know about FDA inspections.

This guide provides essential insights into FDA and EU regulations, along with actionable steps to implement effective quality systems, minimize risks, and maintain GMP standards.

Gain a clear understanding of Computer System Validation (CSV) in life sciences with this handbook by Scilife's GAMP 5 specialists.

This free handbook addresses frequently asked questions about audits and inspections, giving you the clarity and confidence you need. Enter your details below to receive your copy instantly via email.

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

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

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

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

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

Outline specific assignments and steps of broader processes and procedures.

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

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

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

A powerful resource that simplifies the process of identifying, investigating, and resolving non-conformances.

Improve your medical device quality management with our comprehensive Quality Plan Template!

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

Save valuable time in vendor meetings by asking the right questions and identify the perfect eQMS fit for you!

Our Scilife Success Guide is here to help you think outside the box and implement strategies that truly work.

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

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

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

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

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

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

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

Achieve your goals and drive positive change in your organization.

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

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

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

Transform your eQMS proposal from a technical request into an executive vision that demands attention.