UPCOMING WEBINAR 5/22: Medical device internal auditing tips 💻

Join us
  • THE QUALIO PLATFORM

    • icon-nav_Check ring
      Product Overview

      #1 eQMS for life sciences

    • icon-nav_Subttasks
      Design Controls

      Drive a faster and stronger route to market

    • icon-nav_File
      Documents

      Digitize and organize your entire stack

    • icon-nav_Info
      Risks

      Pinpoint, prevent & resolve risks

    • icon-nav_Users
      Training

      Track and demonstrate competence

    • icon-nav_Pencil
      Change Control

      Manage any change easily & effectively

    • icon-nav_Chield
      Audits

      Become 100% audit-ready

    • icon-nav_Chart
      CAPAs & Nonconformances

      Drive continuous improvement

    • icon-nav_Bag
      Suppliers

      Manage suppliers with ease

    • icon-nav_Pie chart
      Analytics

      See your quality landscape at a glance

    • icon-nav_Chat
      Pharmacovigilance & post-market surveillance

      Keep your product compliant

    • icon-nav_Group
      Data

      Connect your QMS information

    PRODUCT TOUR

    Click through an interactive demo

    Learn more
    icon_product-tour
  • OUR SOLUTIONS

    • icon-nav_Setting
      Solutions overview

      An integrated eQMS to help you hit your goals

    • icon-nav_BPM
      Medical Devices

      Get to market faster with unshakeable quality

    • icon-nav_Laptop
      Paper to eQMS

      Ditch the clutter and chaos by going digital

    • icon-nav_Laptop
      Software as Med Device

      Embed quality into the core of your SaMD development

    • icon-nav_Chield
      ISO compliance

      Meet your requirements from 9001 to 13485

    • icon-nav_Drop
      Pharmaceuticals

      Build a world-class pharma quality system

    • icon-nav_Ticket
      CE & UKCA marking

      Bring your medical device to the EU and UK

    • icon-nav_DNA
      Biotech

      Drive life-saving, industry-leading products

    • icon-nav_Star
      FDA clearance

      Unlock the US market by satisfying the FDA

    • icon-nav_Plant
      Cannabis

      Grow regulatory trust and distribute with confidence

    • icon-nav_Chart
      ICH compliance

      Embed international pharma best practice

    • icon-nav_List
      Contract Research Orgs

      Provide compliant, quality-driven life science services every time

    QUALIO INTEGRATIONS

    Qualio integrates with your key business critical applications.

    See integrations list
    icon_solutions-callout
  • CUSTOMER SUCCESS STORIES

    • icon-nav_Sound
      Customer Stories

      Learn how companies like yours use Qualio

    • icon-nav_Heart
      Customer Reviews

      Hear what our customers say about us

    • Headphones-1
      Customer Reference Program

      Love Qualio? Spread the word!

    QUALIO G2 REVIEWS

    Hear from real Qualio customers right now

    See G2 reviews
    icon_customers-callout
  • EXPLORE OUR RESOURCES

    • icon-nav_Archive
      Content Library

      View guides, toolkits, podcasts, and more

    • icon-nav_Chat
      Qualio Blog

      Access tips, tools and insights from real quality professionals

    • icon-nav_Calendar
      Events & Webinars

      Join us at our online & in-person events

    • icon-nav_Smile
      Our Partners

      Search our network for quality expertise near you

    CALCULATE YOUR ROI

    See how much money Qualio can save you by sharpening your quality processes

    Get your ROI
    icon_roi-callout
  • ABOUT US

    • icon-nav_logo
      Company

      Learn about our company, people & investors

    • icon-nav_User+1
      Careers

      Come join the team

    • icon-nav_Star
      Partners

      Become our partner today

    • icon-nav_Email
      Contact

      Get in touch with us

    GET YOUR QUALITY SCORE

    Evaluate your quality maturity with our quick quiz

    Get your score
    icon_about-callout
  • Pricing
  • Book your demo
    Login
Book your demo
Login
Return to blog

    All articles from Molly Calvey

    Compliance
    • May 29, 2024

    The ultimate guide to change control for life sciences companies

    Read article
    Medical Devices
    • March 20, 2024

    14 medical device quality management system requirements for regulatory compliance

    Read article
    Pharmaceutical
    • January 05, 2024

    Pharmaceutical quality management software (QMS): our top picks for 2024

    Read article
    Pharmaceutical
    • November 07, 2023

    Understanding the major pharmaceutical regulations you need to know

    Read article
    ISO 15189
    • June 15, 2023

    What is ISO 15189? A complete overview

    Read article
    ICH
    • May 17, 2023

    What you need to know about ICH Q8

    Read article
    ICH
    • May 15, 2023

    ICH Q9 quality risk management: an introduction

    Read article
    GxP
    • April 14, 2023

    Guide to GxP compliance: processes, challenges and tools

    Read article
    Pharmaceutical
    • January 12, 2022

    What Are The Essential Elements of Pharmaceutical Quality Management Systems? [8 Examples]

    Read article
    Molly Calvey
    Molly Calvey

    Molly has over 8 years of deep quality management knowledge from the pharmaceutical, medical device and laboratory fields. Molly is particularly experienced with FDA, HPRA, MDSAP and ISO 13845 audits.

    Follow me on LinkedIn

    Topics

    • Compliance
    • Medical Devices
    • Quality Systems
    • eQMS
    • Pharmaceutical
    • ISO 15189
    • ICH
    • GxP
    Qualio Logo

    How strong is your quality system right now?

    Evaluate your QMS maturity against Qualio's quality pillars in our quick quiz

    Get your quality score
    • Product
      • Product overview
      • Documents
      • Design controls
      • Risks
      • Training
      • Change control
      • Audits
      • CAPAs & non-conformances
      • Suppliers
      • Analytics
      • Product tour
      • Pricing
      • Integrations
      • Competitors
    • Solutions
      • Solutions overview
      • Paper to eQMS
      • ISO compliance
      • CE and UKCA marking
      • FDA clearance
      • Medical devices
      • Pharmaceuticals
      • Biotech
      • Cannabis
      • Software as medical device
      • Contract research orgs
    • Customers
      • Customer stories
      • Customer reviews
      • G2 reviews
    • Resources
      • Content library
      • Qualio blog
      • Press room
      • Events
      • Podcast
      • Partner network
      • ROI calculator
    • About
      • Company
      • Careers
      • Partners
      • Contact
      • Quality policy
    • Legal
      • Terms of service
      • Privacy policy
    • Social media

    © Qualio — QMS for Life Sciences

    ISO 9001 ISO 27001 badge_quality-powered-by-qualio-1