Quality management resources

Best practice guides, product info and podcasts.
Created by and for life science quality professionals.

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Guide
Regulatory

ISO 9001 compliance checklist

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

ISO 14971 mastery guide

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

ISO 14971 compliance checklist

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

ISO 13485 compliance checklist

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

ISO 9001: ultimate 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 ...
Guide
Medical device/SaMD

Introduction to medical device risk management

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

ICH Q10 compliance checklist

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

How to prepare for ICH Q10 compliance

What is ICH Q10 compliance?  In 2001, a PWC report uncovered shocking levels of inefficiency and waste in the pharmaceutical world, with scrap and ...
Guide
Quality culture

How to build a quality culture

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

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

What is a GxP manufacturing system? Any computerized system controlling the manufacture of a GxP product, such as a pharmaceutical drug, is defined ...
Guide
Regulatory

GxP compliance: electronic records and signatures guide

A collection of quality guidelines and regulations designed to ensure your products and projects are safe, meet their intended use, and adhere to ...
Guide
Medical device/SaMD

Design controls for medical device companies: 6 principles for success

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 ...
Guide
eQMS

10 diagrams for audit mastery

Download our  guide to understand the 4 signs that your audit process needs a boost.   
Product info
eQMS

Our validation approach

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

Complete guide to computerized system compliance in 2022

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

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 ...
Toolkit
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 ...
Product info
eQMS

Qualio datasheet

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

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 ...
Guide
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 ...
Guide
eQMS

Boosting your competitive advantage with an eQMS

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

Qualio+ datasheet

Download your Qualio+ datasheet to:   Learn how our quality-as-a-service support accelerates and simplifies your compliance journey Explore our suite ...
Guide
Medical device/SaMD

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

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

ISO 13485 risk management plan template

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

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 ...
Product info
eQMS

Contract organization quality management software datasheet

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

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 ...
Guide
Medical device/SaMD

Medical device classification guide

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

Ultimate guide to medical device design controls

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

FDA 21 CFR Part 11 checklist

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

How to respond to an FDA 483

Download our guide 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 ...
Toolkit
Pharmaceutical

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 ...
Product info
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 ...
Guide
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 ...
Product info
Medical device/SaMD

SaMD quality management software datasheet

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

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 ...
Guide
Life sciences

Life science quality trends report 2022

Download our trends report to learn: How hundreds of life science quality professionals do their work How they feel about management support, pay, ...
Product info
eQMS

Supplier management datasheet

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

Why cloud-powered quality management is the future

Download your whitepaper to learn:   Why more and more life science professionals are turning to cloud-based electronic quality systems   The real ...
Product info
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 ...
Guide
eQMS

Comparing the top quality management system vendors: G2 2022 report

Access our G2 Winter 2022 guide to learn:   What real eQMS software users think of the vendors and systems on the market The key criteria for ...
Toolkit
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 ...
Toolkit
Certification

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 ...
Toolkit
Regulatory

GxP toolkit

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

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 ...
Guide
eQMS

Why your life science business needs electronic document management

Download our document management whitepaper to learn:   Why more and more life science companies are embracing electronic document management How an ...
Product info
eQMS

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 ...
Product info
eQMS

Training management datasheet

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

Document management datasheet

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

Expanding Med Device Distribution Internationally and in China

Subscribe on any major podcast player. Andy Levien, President and CEO of ArcScan talks to Robert about expanding his medical device company ...
Product info
eQMS

Integrations datasheet

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

How to prepare for ISO 9001 certification

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

How to prepare for ISO 13485 certification

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

The perfect quality assurance plan for pharmaceutical companies

Download our whitepaper to learn: The structure of a solid pharmaceutical quality manual The characteristics of the perfect pharmaceutical QA ...
Guide
Medical device/SaMD

9 ways to improve quality in medical device product development

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

Audit readiness checklist

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

How to evolve to a paperless eQMS

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

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 ...
Podcast
Medical device/SaMD

Using AI to Improve Healthcare Outcomes and Access with Sam Dribin

  Subscribe on any major podcast player. Sam Dribin is the Chief Technology Officer for CureMetrix, an AI company focused on solutions that support ...
Podcast
Medical device/SaMD

Lessons from Building an Open Source Quality Community with Gill Berry

  Subscribe on any major podcast player. Gillian Berry is a qualified clinical nurse specialist and founder of PerCen Technologies. She founded ...
Podcast
Medical device/SaMD

CureMetrix Helps Radiologists Make Better, Faster Decisions With AI

It’s no secret the pandemic kept many people at home for the bulk of the last year. At the same time, businesses that weren’t deemed essential were ...
Podcast
Medical device/SaMD

Funding and Scaling your Med Device Startup with Jen Baird

  Subscribe on any major podcast player. Getting funding and scaling a medical device business alone is challenging. But challenges don't deter ...
Podcast
Quality culture

Quality Management Fundamentals in Aerospace and Life Sciences

  Subscribe on any major podcast player. Cables are everywhere, quite literally. Quality management for a cable testing company can be challenging, ...
Podcast
Quality culture

Defining Quality: The Role, Responsibilities, and Industry

  Subscribe on any major podcast player. Today we're excited to have Laura Araujo, Vice President of Quality at 4G Clinical share her insight into ...
Podcast
Medical device/SaMD

How to Maintain a Quality Culture during Explosive Growth

  Subscribe on any major podcast player. Today’s guest is Kristinn Gylfason, Compliance Officer at Sidekick Health and a lawyer who specializes in ...
Podcast
Medical device/SaMD

Launching the First Single-use Endoscope for Unsedated Pediatric Endoscopy with Dr. Heather Underwood, CEO of EvoEndo

  Subscribe on any major podcast player. Today’s guest is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated ...
Podcast
Biotech

Improving the State of Cell Isolation & Recovery with Andrew Breite from VitaCyte

  Subscribe on any major podcast player. Today's guest, Andrew Breite, Director of Quality at VitaCyte, discusses VitaCyte's contributions to cell ...
Guide
eQMS

12 questions to ask before you buy an eQMS

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