Qualio or Google Drive?

Dedicated eQMS vs. popular file-sharing platform

 

 

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The lowdown

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  • Dedicated, specifically designed eQMS tool

  • Launched 2012

  • Cloud-based, paperless, market-tested eQMS

  • Designed for SMEs

  • Life science focus

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  • File sharing and management system sometimes adapted for eQMS usage

  • Launched 2012

  • Cloud-based storage tool which fulfils basic quality functions

  • No customer focus

  • No industry focus

Features, functionality and usage

Document management

 

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  • Cloud-based library for storing and controlling QMS documentation with native editing, tagging and templates

  • Version control and GDocP baked in as standard


  • FDA- and EU-compliant e-signatures provided as standard for document activity


  • Strong collaboration/commenting features in new editor


  • Cloud-based access point for storing QMS documentation and organizing in folders

  • Core compliance functionality like version control and change histories missing or limited 

  • No built-in e-signature functionality - physical paper printouts or third-party investment and integration required for FDA/EU compliance

  • Archiving old documents or sending new ones for electronic review requires clunky, manual and non-compliant processes

  • Strong collaboration/commenting features

Training management

 

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

  • E-signatures underpin training activity

  • Push training, prompts and reminders to users with workflows and track organizational and departmental training status


  • No native functionality for training employees or capturing evidence of training

  • Lack of compliant e-signature functionality makes printouts or third-party add-ons required

 

Quality event management

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  • Fully configurable workflows for managing any kind of quality event: complaints, CAPAs, change control, deviations
     
  • Build bespoke event templates to capture and act on the information you need to see


  • Not a dedicated eQMS and so no event management functionality


  • Documents of event activity could be stored and Google Forms used to capture data, but no mechanism for pushing, tracking or tracing actions

Design controls

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  • Centralizes and manages all medical device design elements for easy collation of Design History File

  • 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 dedicated design control functionality


  • Design elements could be stored as Drive documents and Google Drawings, but no way to connect these documents, ensure version control, or keep up to date with other data sources without constant manual updates

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 and export Approved Supplier Lists (ASLs) as required


  • Store supplier documents like contracts, quality agreements and SLAs in bespoke folders


  • No functionality for enforcing supplier quality and compliance policies or tracking supplier statuses


  • Audit records could be attached to suppliers, but would require manual version control and upkeep

 

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


  • No native analytical functionality to interrogate quality data


  • Data stored in Google Sheets could be used to build simple visual charts - but would require constant manual updates to be useful

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


  • Easy to use because of basic functionality and familiar Google set-up

  • Performs search and retrieval tasks easily, as well as document collaboration and editing. No way to easily execute other quality management activities without highly manual workarounds and third-party integrations

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


  • Not a dedicated life science tool with in-house expertise, making you responsible for all validation activity


  • Could require additional consultancy support depending on your in-house expertise and comfort levels


  • Validation and re-validation required by you for every significant system change or update from third-party integrated tools

  • Can be implemented theoretically instantly

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


  • Extra effort and cost of third-party integrations unavoidable to fulfil modern quality and compliance requirements


  • Rich API integration set, particularly with other Google products

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 QMS quick and easy


  • Largely basic, inflexible set-up impedes scalability


  • Lack of version control, audit trails and built-in compliance functionality makes usage at scale a risk for regulated businesses

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


  • Offers online training and access to Google Drive Help Center and community


  • Largely intuitive and simple - little or no implementation/training support needed

  • No QA support or QMS documentation templates provided - must be built or bought by the user

Choose Qualio if you:


  • Want a dedicated life science eQMS tool within 60 days

  • Want to invest in a long-term tool that makes quality easy

  • Have plans to launch a high-quality, trusted product to market and comply with relevant regulations

  • Want to house your entire QMS in a single digital tool that simplifies your quality tasks and automates compliance

Choose Google Drive if you:


  • Need some kind of QMS document storage instantly

  • Don't have any budget for a dedicated eQMS

  • Don't have growth or marketization plans


  • Can commit to manual upkeep, workarounds and necessary third-party integrations