Resources

Latest resources

Complete guide to the FDA Quality Management Maturity program

Download our Quality Management Maturity program guide to: Understand the FDA's plans for its innovative new pharmaceutical quality program Get to ...

How to build and measure a culture of pharmaceutical quality

Download our pharmaceutical culture of quality guide to: Learn what a culture of quality actually means in practice for therapeutic companies ...

Pharmaceutical quality in 2025: an overview

Download our 2025 pharmaceutical industry overview guide to: Unpick the core developments on the horizon for pharmaceutical quality professionals in ...

All publications

How to prepare for ICH Q9 compliance PDF guide

Download our ICH Q9 guide to: Understand the core requirements of ICH Q9, the pharmaceutical quality risk management standard Master your risks, from ...

How to prepare for ICH Q8 compliance PDF guide

Download our ICH Q8 guide to: Understand the core requirements of ICH Q8, the pharmaceutical development standard Embed business-wide ICH ...

Quality culture

Audit success playbook

Download our audit success playbook to: Access a wealth of top tips and things to consider before, during and after your upcoming audits Position and ...

Medical device/SaMD

Complete 510(k) submission guide

Download our complete 510(k) submission guide to: Understand the end-to-end process for completing and submitting a 510(k) to the FDA Access top ...

When to adopt an eQMS

Download our eQMS adoption timing guide to: Understand the optimal time to upgrade your quality system with a digital tool Learn the key risks and ...

Medical device/SaMD

510(k) submission checklist

Download our 510(k) submission checklist to: Know what you need to do (and when!) during your 510(k) submission process Tick off each step as you go ...

Using Qualio for management reviews

Download our management review guide to: Explore the difference in the life science quality professional's management review experience with and ...

4 scary life science quality management stories

Download our scary story collection to: Learn the real impact of typical quality management mistakes, from sticking with paper to slipping up on ...

Qualio document migration guide

Download our document migration guide to: Access top tips for an optimized document migration from your legacy system to Qualio Know which documents ...

Using Qualio for external audits

Download our external audit guide to: Explore the difference in the life science quality professional's external audit experience with and without ...

Using Qualio for building a medical device technical file

Download our medical device technical file guide to: See how real medical device companies use Qualio to assemble technical files for compliance with ...

Using Qualio to manage your equipment

Download our equipment management guide to: See how real life science companies use Qualio to manage their vital equipment and physical assets, from ...

Securing funding for your life science start-up

Download our life science start-up funding guide to learn: How to maximize your chances of attracting investments and acquisitions Tips and tactics ...

The business case for electronic GxP management

Whether you need to comply with cGMP, GDP, GDocP, GLP, GCP, or a combination of several, your focus is always on patient safety. But how can patient ...

ISO 9001 compliance checklist PDF

ISO 9001 lays out the baseline requirements for the modern quality management system. Use this checklist PDF to ensure compliance with the particular ...

Medical device/SaMD

ISO 14971 mastery PDF guide

This is a PDF guide for medical device professionals looking to gain a deeper understanding of the risk management process and how it may be applied. ...

Medical device/SaMD

ISO 14971 compliance checklist PDF

ISO 14971 lays out the core risk management considerations for a medical device organization. It is not an auditable standard which you can get ...

ISO 13485 compliance checklist PDF

ISO 13485 lays out the broad quality requirements for the modern medical device quality management system. Use this PDF checklist to ensure ...

ISO 9001: ultimate PDF guide to the core quality management standard

If you want to establish a holistic and functional quality management system from scratch, ISO 9001:2015 is the perfect place to begin. ISO 9001 lays ...

Medical device/SaMD

Introduction to medical device risk management PDF guide

Risk management continues to be a hot topic in the medical device world as regulators place additional emphasis on the role of risk management ...

ICH Q10 compliance checklist PDF

ICH Q10 lays out the broad quality requirements for the modern pharmaceutical quality management system. ICH Q10 incorporates many of the core ...

How to prepare for ICH Q10 compliance PDF guide

Download our ICH Q10 compliance guide to: Understand the ICH Q10 model, the best practice structure for pharmaceutical quality management Take ...

Quality culture

How to build a quality culture PDF guide

In quality cultures, every employee is focused on adhering to quality guidelines, and they always see their peers taking quality actions and talking ...

Guide to GAMP 5, data integrity and quality by design GxP manufacturing PDF guide

Download our GAMP 5, data integrity and GxP manufacturing PDF guide to: Understand the key ingredients of the modern GxP manufacturing system Embed ...

GxP compliance: electronic records and signatures PDF guide

A PDF collection of quality guidelines and regulations designed to ensure your products and projects are safe, meet their intended use, and adhere to ...

Medical device/SaMD

Design controls for medical device companies: 6 principles for success PDF guide

Since 1990, the FDA has required manufacturers of all class II and class III devices, and certain class I devices, to enact design controls, which ...

Our validation approach

Download our validation breakdown guide to: Understand how Qualio follows the latest CSA best practice for rapid, compliant, expert-approved and ...

Quality culture

Phase 1 & 2 clinical trial quality by design guide

Download our clinical trial Phase 1 and Phase 2 QbD guide to: Understand how and why quality by design is the crucial ingredient for the success of ...

Medical device/SaMD

UKCA marking pathway guide

Download our UKCA marking medical device pathway guide to: Get a step-by-step action guide for getting your medical device approved for the Great ...

Medical device/SaMD

CE marking pathway guide

Download our CE marking medical device pathway guide to: Get a step-by-step action guide for getting your medical device approved for the EU market ...

The essential guide to life science supplier management

Download our essential life science supplier management guide to: Understand and tackle the issues, risks and common mistakes connected to the modern ...

Complete guide to computerized system compliance in 2023

Download our computerized system compliance PDF guide to: Understand the evolution from computerized system validation (CSV) to assurance (CSA), and ...

eQMS: build or buy?

Download our build vs. buy guide to: Access a balanced breakdown of the pros and cons of each option Dive into the cost, effort and risk ...

Medical device/SaMD

ISO 14971 toolkit

ISO 14971 is the industry risk management standard for organizations involved in the design, development and manufacture of medical devices. Download ...

Qualio datasheet

Download our electronic quality management datasheet to learn how Qualio: Arms your business with a complete, compliant eQMS for life science quality ...

EU IVDR software datasheet

Download our EU IVDR datasheet to learn how Qualio: Helps your business meet the requirements of the EU IVDR in a single digital quality system ...

Information security management software datasheet

Download our information security management datasheet to learn how Qualio: Helps your business build an unshakeable and fully controlled information ...

Quality culture

Consumers & quality sentiment report

Download our consumers and quality sentiment report to: Access the findings of our comprehensive public survey of 2,002 American household ...

Boosting your competitive advantage with an eQMS PDF Guide

Download our PDF guide to learn: How an eQMS helps life science companies like yours augment their competitive advantage How digital quality ...

Medical device/SaMD

Assembling a Design History File (DHF) for your medical device PDF guide

Download our Design History File (DHF) PDF guide to: Understand what a DHF is and how it fits into your medical device quality management activities ...

ISO 13485 risk management PDF plan template

Download our ISO 13485 risk management PDF plan template to: Access a ready-made 8-section template of a typical ISO 13485 risk management plan ...

Annex SL: the core of your ISO journey

Download our Annex SL guide to learn: How Annex SL forms the overarching 'high-level structure' governing all modern ISO standards The 10 clauses of ...

Contract organization quality management software datasheet

Download our contract organization quality software datasheet to learn how Qualio: Gives contract research and manufacturing organizations a trusted ...

The return on investment of an electronic quality management system (eQMS)

Download our eQMS return on investment breakdown guide to: Understand the typical cost savings associated with an electronic quality management ...

Medical device/SaMD

Medical device classification PDF guide

Download our medical device classification PDF guide to: Understand what regulatory class your medical device falls under for FDA and EU compliance ...

Medical device/SaMD

Ultimate PDF guide to medical device design controls

Download our ultimate design controls breakdown PDF guide to: Become an expert in medical device design controls Get to grips with design control ...

FDA 21 CFR Part 11 checklist PDF

Download your FDA 21 CFR Part 11 checklist PDF to: Get to grips with the FDA's requirements for the integrity, quality and compliance of electronic ...

How to respond to an FDA 483

Download our PDF to: Learn how to respond to an FDA Form 483 Know the 5 things you should consider if you receive a 483 Access FDA inspection tips ...

ICH Q10 toolkit

Download our ICH Q10 toolkit to: Understand the fundamentals of ICH Q10, from the 4 lifecycle stages to the 4 pillars Take actionable steps towards ...

Medical device/SaMD

EU MDR software datasheet

Download our EU MDR compliance software datasheet to learn how Qualio: Arms your business with a complete, EU-compliant eQMS for medical device ...

Medical device/SaMD

EU MDR general safety and performance requirements (GSPR) checklist

Download our EU MDR general safety and performance requirements (GSPR) checklist to: Understand every requirement your business and device(s) must ...

Medical device/SaMD

TGA essential principles checklist

Download our TGA essential principles checklist to: Understand every requirement your business and device(s) must follow for Australian medical ...

Medical device/SaMD

SaMD quality management software datasheet

Download our SaMD quality management datasheet to learn how Qualio: Arms your business with a complete, compliant eQMS for software as medical device ...

Pharmaceutical quality management software datasheet

Download our pharmaceutical quality management datasheet to learn how Qualio: Arms your business with a complete, compliant eQMS for pharmaceutical ...

Cannabis quality management software datasheet

Download our cannabis quality management datasheet to learn how Qualio: Arms your business with a complete, compliant eQMS for cannabis ...

Supplier management datasheet

Download our supplier management datasheet to learn how Qualio: Gives your business unshakeable control of your third-party relationships Equips your ...

Medical device/SaMD

Medical device quality management software datasheet

Download our medical device quality management datasheet to learn how Qualio: Arms your business with a complete, compliant eQMS for medical device ...

Comparing the top eQMS vendors: G2 2024 report

Access our G2 2024 PDF review guide to learn: What real eQMS software users think of the vendors and systems on the market The key criteria for ...

Medical device/SaMD

ISO 13485 toolkit

ISO 13485 is the definitive quality standard for organizations involved in the design, development and manufacture of medical devices. Download our ...

ISO 9001 toolkit

ISO 9001 is the core, foundational quality management standard for modern organizations. Download our ISO 9001 toolkit to: - Get to grips with the ...

GxP toolkit

Whether your business operates a laboratory, clinic or pharmaceutical manufacturing line, GxP is essential. Download our GxP toolkit to: Understand ...

Design controls management datasheet

Download our design controls management datasheet to learn how Qualio: Gives your business a concerted, compliant and accelerated route to market for ...

Why your life science business needs electronic document management

Download our document management best practices PDF to learn: Why more and more life science companies are embracing electronic document management ...

Quality event management datasheet

Download our quality event management datasheet to learn how Qualio: Unlocks end-to-end control and visibility of all your quality events Drives ...

Training management datasheet

Download our training management datasheet to learn how Qualio: Provides a robust and holistic training environment for life science companies Embeds ...

Document management datasheet

Download our document management datasheet to learn how Qualio: Empowers your organization with a centralized digital repository of quality ...

Quality analytics datasheet

Download our quality analytics datasheet to learn how Qualio: Empowers your organization with deep visual analytics of your quality management system ...

Integrations datasheet

Download our datasheet to learn how Qualio's integrations functionality: Connects your QMS to your other business-critical systems Breaks down ...

How to prepare for ISO 9001 certification

Download our ISO 9001:2015 PDF guide to: Learn how to prepare for certification Take the first steps on your accreditation journey Understand the ...

How to prepare for ISO 13485 certification

Download our ISO 13485 certification preparation PDF guide to: Understand the ISO 13485:2016 standard and its requirements Get to grips with what ...

The perfect quality assurance plan template for pharmaceutical companies

Download our quality assurance plan template to learn: The structure of a solid pharmaceutical quality manual The characteristics of the perfect ...

Medical device/SaMD

9 ways to improve quality in medical device product development PDF guide

Download our PDF guide to learn: The 9 things your business needs to do to maximize your medical device quality Common issues for medical device ...

Medical device/SaMD

Audit readiness checklist for medical device companies

You know you want to be ready for the next audit, but how do you prepare? Use this complete checklist to evaluate your medical device company’s audit ...

Audit readiness checklist PDF

What we will cover This checklist PDF will guide you through 12 different aspects of your company's quality procedures and systems including: ...

How to evolve to a paperless eQMS

Access our PDF guide to learn: The 3-step migration journey from paper to an electronic quality management system (eQMS) Top tips and recommendations ...

Life science culture of quality toolkit

Download our life science culture of quality toolkit to learn: What a culture of quality looks like for medical device, pharmaceutical, biotech and ...

12 questions to ask before you buy an eQMS PDF guide

Access our PDF guide to learn: The 12 specific and detailed questions you should be asking eQMS vendors on your system hunt How to pinpoint the right ...