Qualio or BizzMine?

A balanced eQMS comparison to help you decide

 

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BizzMine

 

See why our customers prefer us

The lowdown

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  • Holistic, integrated eQMS

  • Founded 2012

  • 500+ customers

  • Cloud-based, paperless eQMS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus

BizzMine logo



  • Provides both eQMS and Vario HSE platforms

  • Founded 1995

  • 1000+ customers

  • Cloud-based or on-premise quality platform

  • Supports/simplifies quality and compliance

  • Size-agnostic

  • Industry-agnostic

Features, functionality and usage

Document management

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  • Cloud-based document library with e-signatures, native editing, tagging, templates and review/control workflows


  • Documents viewed, edited and collaborated on within the system




 

  • Document control module allows storage, categorization and control of documents with compliant e-signatures, version control, approval prompts and so on

  • No native document viewing, editing or collaboration - documents must be downloaded, read and edited outside the system

  • Some customers report unintuitive ID-based search

Training management

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  • Train users on eQMS documents and house training records in a digital repository

  • Prompts, reminders and assessments keep training moving and prove competence

  • Build and cascade Training Plans for proactive team training


  • Build training forms and record completed training in a digital database

  • Assign assessments and automate reminders for trainees


  • View color-coded training matrices to spot and fix competency gaps

Quality event management

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  • Fully configurable workflows in a single area for managing any kind of quality event: complaints, CAPAs, change control, deviations, etc.

  • Editable form templates allow bespoke information capture and response within a scalable, malleable eQMS


  • Separate system areas for management of CAPAs, complaints, calibrations and change control

  • Configurable workflows, but some customer reports of difficulty building and running them

Design controls

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  • Dedicated design control area centralizes and manages all medical device design elements for easy collation of Design History File: ISO 14971 and FMEA risk management, user requirements, open device issues, etc.

  • Pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail with plug-and-play API integrations


  • No design control functionality




  • Not specifically designed for medical device companies

Supplier management

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  • Build a configurable database of your supply chain in a dedicated supplier management area

  • Set bespoke policies for manufacturers, service providers, distributors, consultants and more – then use them to enforce supplier requirements and ensure compliance

  • Attach key documents, manage audit details and export Approved Supplier Lists (ASLs) as required


  • Schedule supplier reviews, raise complaints and build SCARs from a dedicated supplier library

Audit management

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  • Quality event forms and workflows can be configured to capture and respond to audit data

  • Attach any kind of file format to audit reports

  • Trigger corresponding event workflows to respond to findings instantly


  • Audit module allows construction of forms for data capture


  • Attach scanned reports and images of findings

  • Build associated CAPA events for follow-up

 

Analytics

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  • Rich analytic dashboards for at-a-glance visibility of document, training, event and supplier management activity

  • Dive into visual eQMS data to spot trends, fix bottlenecks and more


  • Solid analytic functionality - build charts to capture and track system data

  • Some customer reports of difficulty manipulating and analyzing data; some still opting for export to Excel

Health, safety and environment

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  • eQMS only: no dedicated HSE functionality


  • Events forms and workflows could be configured to manage HSE elements like incidents, risks and substances


  • Separate and non-integrated VARIO platform provides dedicated HSE management functionality

  • Modules for incidents, inspections, substances, risks and materials

 

Ease of use

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  • Designed with natural, intuitive ease of use at the core


  • Clean, minimal UX to maximize user engagement and simplify training and onboarding

  • Consistently ranked the easiest eQMS software to set up and use


  • Only available in English


  • Slightly complicated but generally strong UX with good customer feedback

  • Strong emphasis on mobile usage and creation of different system 'environments' for different teams and departments

  • Some customers report difficulty building and managing workflows, and accessing documents

  • Multilingual options

Implementation & validation

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  • Industry supplier guided by the latest FDA and GAMP computerized system assurance (CSA) guidelines for a rapid, least burdensome validation approach for customers

  • Validation document pack provides all objective functional evidence of system suitability. Customers need only perform extra software testing if they feel it’s risk-appropriate

  • Average implementation time frame: 60 days


  • Provides validation documentation pack of system functionality to help customers focus only on higher-risk configurations and system applications

  • Customer reviews suggest generally quick and easy onboarding and set-up

 

Ecosystem

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  • Designed to seamlessly connect to your other business-critical tools. Keeps your teams in their familiar, specialized systems while the eQMS absorbs real-time data from them

  • Plug-and-play API integrations with Salesforce, Jira, Zephyr, Xray, Azure DevOps, Asana, TestRail and ComplianceWire, with NetSuite integration on the way


  • ERP and CRM integrations possible to pull data into the system



  • No other integrations out-of-the-box, but API allows custom integrations to be pursued

Scalability

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  • Designed to ‘grow with you’ and guide your business up the quality maturity curve to marketization and beyond

  • Flexible, configurable make-up makes tweaking processes, adding new users and scaling up the eQMS quick and easy

  • Unlimited free basic document and training access turns Qualio into a business-wide quality tool


  • Highly configurable workflow-based system allows the platform to scale with you

  • Modular structure could allow expansion into new system areas as required, but with additional user costs

Customer support

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  • Commits to a long-term partnership with customers. Customer success managers, plus high-touch 24/7 support from team members in the US and EMEA with live chat and Help Center

  • Qualio+ package provides targeted QA expert support and pre-built standard-specific system templates to accelerate compliance


  • High marks from customers for responsiveness, level of support, and general satisfaction


  • Support Portal and responsive support team from a series of international locations


  • No pre-built QMS documentation templates provided, no additional quality and compliance support


  • Generally good customer feedback about strength and speed of support

Choose Qualio if you:


  • Are a growing life science company and want industry-tailored eQMS functionality (like design controls) to match

  • Want a flexible eQMS to tailor to your exact business needs, with pre-built quality document templates available

  • Want to integrate your eQMS with multiple tools like CRM and design platforms

  • Want the easiest to use, most scalable cloud eQMS on the market

Choose BizzMine if you:


  • Aren't a life science start-up or scale-up 


  • Want a HSE platform alongside your eQMS


  • Need a multilingual or non-English quality platform


  • Want an on-premise platform