Qualio or paper? eQMS comparison

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

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


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

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


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


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

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


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

Ecosystem


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

Scalability


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


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

Cost

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

Qualio or paper?

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The lowdown

Features, functionality and usage

Choose Qualio if you:

Choose paper if you: