Qualio or paper?

Dedicated eQMS vs. old-school tool



See why our customers prefer us

The lowdown


  • Dedicated, specifically designed eQMS tool

  • Launched 2012

  • 500+ customers

  • Digital, cloud-based, automated

  • Designed for SMEs

  • Life science focus

  • No trees harmed in the making of this product

  • Universal method for manual information recording

  • Launched 105

  • 8 billion users

  • Completely analog: 0 automation

  • Designed for everyone

  • Usable in any business for any purpose

  • Requires tree sacrifice

Features, functionality and usage

Document management


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  • Cloud-based library for storing and controlling QMS documentation

  • Native editing, tagging and templates for automatic consistency

  • Version control, GDocP and ALCOA+ baked in as standard

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

  • Requires physical storage, organization, filing and retrieval

  • Editing, categorization and standardization all demand continual conscious effort to prevent loss, error, duplication and variation

  • Version control, change histories and any kind of integrity require constant manual upkeep work

  • Wet signatures legally binding and compliant, but require physical presence and manual desk-to-desk collection

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

  • Manually present documents to trainees and store completed physical training records

  • Training completion requires wet signature collection from every single employee

  • Users must be individually notified and provided with printed documents. Tracking completion requires trawling through physical storage areas for records

Quality event management

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  • Fully configurable workflows for managing any kind of quality event: complaints, CAPAs, change control, deviations
  • Explore events by status, type, root cause and more

  • Instant digital visibility allows targeted problem-solving for continuous improvement

  • Requires manual coordination of assigned personnel and combination of records for each event step

  • No way to see events by status or other criteria, or to compare events for root cause analysis without side-by-side paper comparisons

  • Manual, 'real world' actions ungoverned by workflows not necessarily performed in a repeatable way

  • 'Murky' paper clutter makes continuous improvement and root cause remediation highly difficult

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

  • Up-to-date issues, user requirements, risks, review info and associated documents must all be separately stored in a logical, interacting way for any visible device narrative

  • Manual collation of data from multiple sources often out of date as soon as it's completed

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 ever-expanding physical folders

  • No way to automatically enforce quality and compliance policies or track supplier statuses

  • Audit records generated for each supplier would require manual version control and upkeep


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 with basic literacy education

  • Works well in micro-organizations in their earliest days

  • Rapidly breaks down and becomes unsustainable as companies expand past 10 people: physical storage and retrieval becomes exponentially harder and saps energy from value-add activity

  • AIIM estimates employees of paper-based companies lose half an hour each day just searching for information they need

  • Long back-and-forth processes with uncontrolled document versions and siloed functions make compliant traceability and harmonized work highly difficult

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

  • No validation required; not a computerized system

  • Available instantly

  • Latest CSA guidelines from FDA and ISPE reveal industry push for regulated companies to digitize and move from paper - computer systems preferable over non-compliant or inefficient manual systems


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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

  • Can record information from any system you use - with lots of manual searching and recording

  • Instant synchronization of accurate data impossible

  • Inherently siloed: paper documents squirrelled away in drawers and cabinets

  • No single source of truth: the average paper document is copied 19 times, and difficulty of version control damages traceability and accuracy


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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

  • Highly unscalable; breaks down as companies expand

  • Lack of version control, audit trails and compliance makes usage at scale a major risk for regulated businesses

  • Not suitable for increasingly remote life science world

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 QMS content and additional QA support to accelerate compliance

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

  • No support or training required for day-to-day usage

  • No support available as operational issues emerge

  • QMS documentation templates must be manually built or bought

  • Over half of life science companies have already turned away from paper, with the number growing


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  • Varies based on business size and complexity: around $20,000 annually on average

  • Delivers substantial return on investment by accelerating speed to market, sharpening processes and mitigating compliance risk

  • No hidden costs: predictable SaaS expenditure which only requires hardware to run

  • Low upfront costs gradually cancelled out by creeping usage and storage costs

  • Inherently wasteful: 7.5% of all paper documents are lost forever

  • AIIM estimates  small organizations spend a minimum of
    $25,000 a year on paper production and usage costs, rising to $175,000 for larger companies

  • A single filing cabinet costs $25,000 to fill and $1,500 a year to maintain

  •  The average company spends $20 on labor to file a document, $120 to find a misfiled document and $220 to reproduce a lost document

  • Printers, toner cartridges, paper, writing tools, shredders, photocopiers, staples, paperclips, folders, cabinets and extra required headcount all present exponentially rising costs as headcount and QMS complexity grow

  • Manual data collection, department siloes and inaccurate documentation all potential triggers of QMS failures with their own substantial costs: recalls, site closures, reputational damage, etc.

Choose Qualio if you:

  • Want a dedicated life science eQMS tool within 60 days

  • Want to invest now to save money in the long run

  • 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 eliminates manual headaches and makes quality and compliance easy

  • Love trees

Choose paper if you:

  • Need some kind of QMS info storage instantly

  • Don't have any budget for a dedicated eQMS

  • Don't have growth or marketization plans

  • Can commit to upkeep and highly manual processes

  • Hate trees