Qualio: public-source profile

Product: Qualio, a cloud quality-management platform, now also marketed as an “Agentic Compliance Platform” with “Compliance Intelligence” and AI agents. Separate commercial items: Qualio Plus (content and advisory), plan tiers Foundation, Growth, and Scale, and an Integration Hub add-on. Vendor: Everworks Limited, trading as Qualio. Irish company number 508152. Registered office (terms effective 13 August 2024): 13-18 City Quay, Dublin D02 ED70, Ireland. Founder and CEO: Robert Fenton. Category: Life-sciences electronic quality management system (eQMS) and, on 2026 pages, a compliance platform covering quality processes, design controls, and regulatory-framework gap analysis. Not an MES, ERP, or LIMS. Verification date: 2026-10-02. Scope: Public web sources only.

1. Overview

Qualio is a cloud-only, multi-tenant eQMS for medical device, SaMD, GxP software, pharma, and biotech companies, now sold as an “Agentic Compliance Platform” that layers AI gap analysis and regulatory monitoring on document control, training, supplier quality, and quality events. Its plans run from teams preparing a first regulatory submission to multi-site operations, and Qualio reports “700+ highly regulated customers” (Qualio homepage; Pricing).

Qualio runs one shared application for all customers on Amazon Web Services, sold as an annual subscription in three plans plus an implementation fee. Pricing is quote-only; Qualio publishes no list price.

The homepage also lists cannabis and contract research organizations as served industries. Foundation is for teams formalizing quality management before a first submission. Growth is for companies managing several markets and frameworks. Scale adds custom configuration, custom pricing, and dedicated success staff.

What it is not:

Not an MES, batch-record, or equipment-control system. Qualio’s product, pricing, and integration pages describe no shop-floor execution, electronic batch records, or machine integration.
Not an ERP or LIMS. The integration catalog has no ERP or LIMS connector.
Not a substitute for legal obligations. The July 2021 and August 2024 terms both say the platform is a quality-management tool and not a substitute for standards required by law (Terms, effective 13 Aug 2024; Terms, effective 14 Jul 2021).
Not Qualio Plus. The 2024 terms define Qualio Plus as proprietary content (policies, SOPs, work instructions, templates, training decks) sold with a service.

2. Company and product identity

Point	Fact	Source
Legal entity	Everworks Limited, trading as Qualio, incorporated in Ireland, company number 508152.	2024 terms clause 1.2; 2021 terms clause 2.1
Registered office	2024: 13-18 City Quay, Dublin D02 ED70. 2021: Westlodge, Deerpark, Mitchelstown, Co. Cork, with formal notices to City Quay.	2024 terms clause 1.2; 2021 terms clauses 2.1, 13.2
Governing law	Irish law; Irish courts have exclusive jurisdiction, with a carve-out for Qualio to enforce an Irish order elsewhere.	2024 terms clause 16.4; 2021 terms clause 13.3
Founding	Fenton, 25 May 2021: “When I founded Qualio in 2012.” The same-day release names him Founder and CEO, datelined San Francisco.	Fenton post; PR Newswire, 25 May 2021
Series A	$11 million, first half of 2020 (Fenton: “our $11M Series A raised during the first half of 2020”).	Fenton post; PR Newswire
Series B	25 May 2021: $50 million led by Tiger Global, with Menlo Ventures. Existing investors per the release: Frontline Ventures, MHS Capital, Operator Partners, Sorenson Ventures, Storm Ventures. Fenton’s post omits Operator Partners. The release says “To date, Qualio has raised more than $63 million.”	PR Newswire; Fenton post
Later funding	Company page: “We’ve secured 8 rounds and over 60 million dollars of investment.” No round list.	Company page
Leadership	Robert Fenton, Founder and CEO. Mirko Hallenberger, Finance. Kevin Duggan, Engineering and Product. Suresh Balasubramanian, Marketing.	Company page
Workforce	2021: “all-remote,” with teammates in the San Francisco Bay area and customers “in 19 countries.” 2026: “globally distributed team.”	PR Newswire; Fenton post; company page
Former name	CB Insights lists ZenDoc as a former name. Qualio’s company page, 2021 posts, and terms do not use it.	Search index
Product name	Qualio, with no published version brand.	Homepage; terms

3. Pharma, biotech, and device relevance

Pharma positioning. Qualio’s pharma page says the software supports FDA, EMA, ISO, ICH, and GxP requirements, with workflows for documents, training, change control, suppliers, events, and audit trails, and names CAPA, deviation, and OOS tasks (Pharma solution page).
FDA warning letter naming Qualio at a customer. On 3 June 2025 CDRH issued a warning letter to Insightra Medical Inc. (Clarksville, Tennessee) about the Double Pump and Ultra IABP catheter kits. FDA quotes the firm’s SOP-15 (CAPA, effective 26 October 2022): CAPAs “are generated and documented in the Qualio system, an electronic record system used by your firm to manage quality documents.” Complaint CMP-44 went into “the Qualio database” on 29 February 2024 after receipt on 22 January 2024; CMP-36 went in on 4 December 2023 after the firm learned of it in October 2023. Insightra’s 14 February 2025 response said “the Qualio software will be modified to include a provision for closure time justification” for complaints open more than 30 days. FDA called the response inadequate. The cited violations are Insightra’s (FDA warning letter CMS 706921).
21 CFR Part 11. Qualio’s validation FAQ (updated 3 October 2025, Susan Griffith) says the validation pack includes a Part 11 assessment. It reminds customers that 21 CFR 11.100(c) requires the customer to certify its electronic signatures to FDA, and gives the Rockville mailing address (Validation FAQ).
ISO certificates. Qualio’s public PDF holds three SGS North America certificates, signed by Viq Mohammed, Director of Technical Accreditation, addressed to 268 Bush Street #3334, San Francisco, CA 94104 (ISO PDF):
1. ISO 9001:2015, US20/819944173, issued to “Qualio.” Scope: development of a SaaS cloud-based eQMS and governance, risk, and compliance platforms by a fully remote workforce. Valid 7 August 2025 to 7 August 2028. Issue 3. Certified since 23 December 2020.
2. ISO/IEC 27001:2022, US22/00000047, issued to “Qualio, Inc.” Scope: the ISMS for customer information and intellectual property related to the SaaS platform, per Statement of Applicability version 3.0 (July 2025), fully remote workforce. Valid 6 August 2025 to 7 August 2028. Issue 4. Certified since 9 August 2022.
3. ISO/IEC 27701:2019, US25/00000319, issued to “Qualio, Inc.” Valid 6 August 2025 to 7 August 2028. Issue 2. Certified since 6 August 2025. Its scope page is not in the public PDF.
The July 2026 DPA says Qualio holds 27001, 27701, 9001, and 42001, with certificates on request (DPA). The certificates name Qualio or Qualio, Inc. in San Francisco; the 2024 terms name Everworks Limited in Dublin.
Frameworks. Foundation includes 3 frameworks and Growth 5, labeled “FDA, MDR, ISO, GxP.” Extra frameworks cost more.

Vendor counts:

Homepage: “Trusted by 700+ highly regulated customers across the globe.”
PR Newswire, 25 May 2021: “more than 250 customers” across medical device, pharmaceutical, biotech, and contract service providers, naming Medable, Paula’s Choice Skincare, Proscia, and Ginkgo Bioworks; “more than 260 percent revenue growth year-over-year,” no baseline given.
Fenton, same day: “250 inspirational customers,” “100 amazing teammates,” trust “in 19 countries,” with ArcScan, FifthEye, and 4G Clinical as examples.
Homepage: “80% reduction in audit prep time | 5x ROI in 2 months | 60% lower consultant spend,” with no study cited.
Homepage: “G2 4.7/5” from “667 reviews.”

4. Capabilities

Capability	Plan status	What Qualio says	Source
Document control	Plan feature	“Build, distribute, and store quality documents with version control and approval workflows.”	Pricing page
Training management	Plan feature	“Standardize and automate training compliance.”	Pricing page
Supplier quality	Plan feature, configurable	“Centralize supplier oversight.”	Pricing page; validation FAQ
Quality events (CAPA, deviations)	Plan feature	“Configure and run action workflows for quality events.” The row shows “5 templates” (Foundation) and “Unlimited” (Growth) by column order.	Pricing page
Design controls	Plan feature, configurable	“Manage product lifecycles from ideation to final delivery.”	Pricing page; validation FAQ
Resource library	Plan feature	Imports data objects (batch numbers, equipment, customers, products) and links them to events.	Pricing page; integrations
Reporting	Plan feature	“Detailed dashboards and analytics.” The 2024 terms name Amazon QuickSight and let Qualio withdraw it, which ends customer QuickSight access.	Pricing page; 2024 terms clause 10.7
Frameworks and gap analysis	Plan feature	Foundation 3 frameworks, Growth 5, more for a fee. Homepage: AI gap analysis, evidence cross-mapping, monitoring.	Pricing page; homepage
Qualio Copilot and AI	Plan feature	Copilot, gap analysis, documentation mapping, remediation guidance, automated evidence collection, and continuous monitoring under “Agentic Compliance Capabilities.” The 2024 terms say services are “powered in part” by third-party machine-learning models Qualio chooses, that output can be inaccurate, that the customer must review it, and that Qualio disclaims liability. Beta features are “as is,” not for production, and can be withdrawn.	Pricing page; 2024 terms clauses 4.7, 10.6, 11.5
E-signatures and audit trail	Validation documentation	Part 11 assessment in the validation pack.	Validation FAQ
Backend customization	Not offered	“Nothing in the platform backend can be customized for individual customers by the customer or Qualio engineers.”	Validation FAQ

The company page lists “six pillars of quality” as Qualio’s model of a quality system. In 2021 Fenton wrote of “twelve pillars.”

5. Architecture and deployment

Hosted SaaS. The 2024 terms describe an “online, hosted quality management platform” used through the customer’s own device and internet connection (clause 3).
Multi-tenant, single application. The validation FAQ says Qualio is “a web-based, multi-tenant system that runs identically for all customers,” with “only one application running.” Customer data is “segregated logically in the software instead of physically with hardware.” Production and sandbox “are using the same application and database” with segregated data; sandbox configuration does not carry into production. Customers generally cannot decline functional updates. Some features sit behind feature flags.
Versions. Every deploy is a release, and the in-app version number is the release date (example: 22 December 2021). The FAQ records an ISO 13485 auditor objecting to the lack of a conventional version number; Qualio answers that each version traces to its code.
Hosting (DPA Exhibit C). Production runs on Amazon Web Services; Qualio operates no data centres. Data at rest uses AES-256 or equivalent. Privileged production access requires multi-factor authentication; shared accounts are prohibited. Systems span multiple availability zones. Backups are encrypted and stored separately. RTO and RPO are “defined and tested,” with no numbers or region published. An independent firm penetration-tests production annually. Exhibit C is headed “Qualio, Inc.,” while the DPA’s contracting party is Everworks Ltd.
SLA (SLA, last updated 9 December 2022). Support hours: Monday to Friday 6 am–5 pm Pacific (excluding US holidays), 8 am–6 pm GMT, and 8:30 am–4 pm Australian Eastern (excluding local holidays). Routine tickets are acknowledged within 24 business hours. Backups run at least daily, encrypted, with recovery tested at least yearly under Qualio documents POL-14 and POL-42.
Availability. Target of 99.9 percent per month, on commercially reasonable efforts; scheduled maintenance is excluded. Service credits against future fees: 10 percent below 99.9 (to 99.0); 15 percent below 99.0 (to 98.5); 20 percent below 98.5 (to 98.00); 25 percent below 98.00 (to 97.50); 40 percent below 97.50 (to 95.00); 50 percent below 95.00. Exclusions: force majeure, internet beyond Qualio’s demarcation, acts of the customer or third parties including the hosting provider, equipment outside Qualio’s control, and suspension under the agreement.
Severity targets. Severity 1 (down, no workaround): acknowledge in 1 hour, workaround in 4 hours, permanent fix in the next suitable window or emergency maintenance. Severity 2 (wrong results): acknowledge in 2 business hours, workaround in 1 business day, fix in 5 business days. Severity 3 (minor): acknowledge in 24 business hours, workaround in 3 business days, fix in the next scheduled release. Unclassified issues are Severity 3. Contact: support@qualio.com.
Data processing (DPA, effective 15 July 2026). Everworks Ltd, trading as Qualio, is processor. Laws named: CCPA/CPRA, GDPR, the Swiss Federal Act of 19 June 1992, and the UK Data Protection Act 2018. Qualio commits not to sell personal data or use it outside the business purpose. The subprocessor list is inside the product only. New subprocessors trigger notice and a 30-day objection window; if unresolved after another 30 days, the customer can terminate the affected service for a pro-rated refund. EEA, Swiss, and UK transfers use EU standard contractual clauses under Irish law; UK transfers use the ICO Addendum B.1.0 (laid 2 February 2022). No special-category data is transferred. Data is deleted within 30 calendar days of termination, with a deletion certificate within 30 days of request. DPO: Edda Pernice, privacy@qualio.com. Customers can audit after an incident, on reasonable belief of noncompliance, at a regulator’s request, or once a year, at their own cost. Material vulnerabilities are fixed within 90 days unless otherwise agreed.
Deployment options. Cloud subscription only. Qualio offers no on-premise or private-cloud option on its pages.

Qualio’s validation position: because every customer runs the same application, repeating Qualio’s functional tests is redundant, and an eQMS is “low-risk, non-product software” with no direct impact on patient safety. Configuration of Events, Suppliers, and Design Controls still needs a configuration document, and API setup and intended use stay with the customer’s validation.

6. Integrations

Kind	What Qualio documents	Depth
Core, included	SSO, OneDrive, and Jira at no additional cost. The integrations page also lists Azure AD, Google Suite, and Okta.	Named connectors
Integration Hub (Foundation add-on)	GitHub, Azure DevOps, Intercom, TestRail, Zephyr Scale, Asana, Xray, GitLab, plus the core three. The page says the add-on unlocks the dev-tools catalog “with 2 integrations” and shows the longer logo list. On Growth it unlocks the full catalog with 3 integrations.	Plan-gated
CRM and support (Growth)	Salesforce (accounts, opportunities, cases), HubSpot (issues into events), Zendesk (tickets into quality events), Intercom (conversations into complaints), Microsoft Dynamics (complaints and adverse events), Linear.	One-way sync descriptions
Design-control feeds	Jira, Asana, Azure DevOps, TestRail, GitHub, GitLab, Xray, and Zephyr Scale feed requirements, tests, or trace matrices into Design Controls.	Marketing descriptions
Training	ComplianceWire receives Qualio documents.	One connector
Developer API	Listed on the pricing page. The validation FAQ says the API changes how data enters, not application behavior; customers validate their API configuration. No public API reference.	Exists
AI-to-system protocol	“Open protocol for AI-to-system communication,” marked “coming soon.”	Not released
ERP, LIMS, MES	None in the catalog.	None

7. Pricing and commercial model

Pricing is quote-only; Qualio publishes no list price. The pricing page says “Request Pricing” and “Talk to us for a quote.”

Plans. Foundation: 5 edit users, unlimited basic users. Growth: 10 edit users, unlimited basic users. Scale: “custom pricing, custom implementation,” with dedicated success and support.
Implementation fee “applies to all plans.”
Subscription. Annual, recurring, including updates, cloud storage, and support, “with no hidden fees.”
Add-ons. Extra edit users, extra frameworks (“additional fee”), extra Growth instances for multiple sites or entities, and Integration Hub.
Services. Qualio Plus and professional services (onboarding, consulting) are priced on the order form (2024 terms clauses 2.8, 4.5, 4.6).
Order-form terms (2024 terms section 6). Fees follow what was purchased, not usage. Payment obligations are non-cancellable and fees non-refundable. Quantities cannot be reduced mid-term. Invoices are due in 30 days. After notice and a 10-day cure period, Qualio can suspend access and charge 2.0 percent monthly late interest (or the legal maximum, if lower). Overage bills at order-form rates. Qualio can audit usage. The 2021 terms set euro as the default currency and 1.5 percent late interest; the 2024 fee section names no default currency.
Confidentiality. The 2024 terms treat the order form, including pricing, as confidential.
Renewal. Qualio can set a new fee before renewal; the customer can refuse in writing at least 30 days before term end (clause 7.2).
Time to live. Pricing FAQ: “most customers are live within 30 to 60 days.” Homepage: “go live 2 weeks faster than traditional eQMS validation methods” and “Only 1% of our customers choose to validate themselves.”

Public money that is not a list price

USAspending and TED searches on 2 Oct 2026 found no contract or notice naming the Qualio software company. A 2024 French TED award (notice 743073-2024) lists “QUALIO - Université de Besançon,” a university water-testing laboratory unrelated to the software company. Funding totals ($50 million Series B; “more than $63 million” raised by May 2021) are investment, not customer spend.

Questions a buyer should ask

How does the order form define edit users versus basic users?
What does the implementation fee cover: migration, validation pack review, Qualio Plus content?
Which frameworks are included, and what does each extra framework cost?
Is Integration Hub in the quote, and which systems are in scope?
Are sandbox instances included, and are extra production instances priced per site?
Is there a cap on renewal increases?
Is acceptance of Qualio’s validation tests written into the order form?
Which AWS region holds production data, and what are the RPO and RTO numbers?
Which AI features are included, which model providers process customer text, and how are beta features kept out of GxP use?
What analytics remain if Qualio withdraws Amazon QuickSight?

8. Implementation and validation support

Qualio says an onboarding team of “industry experts” gets most customers live in 30 to 60 days, with weekday chat and email support, and that “86% of customers self-serve through our Knowledge Base” (pricing FAQ). The 2024 terms make onboarding part of professional services, exclude Qualio liability for delays caused by the customer, and bar resale of Qualio Plus content.

Validation approach (validation FAQ, 3 October 2025):

Qualio tests the shared application with CircleCI and GitHub and advises customers not to repeat functional testing.
Qualio cites FDA CSA guidance and ISPE GAMP 5 as moving away from routine IQ/OQ/PQ, and supplies test scripts customers can format as IQ/OQ/PQ on request.
Sion Wyn, described as editor of GAMP 5 and an FDA advisor, reviewed Qualio’s assurance approach.
The pack includes a Part 11 assessment. Default content tells customers to qualify Qualio as a supplier, write intended use, and state that the system adds no additional risk to product or patient safety.
Qualio staff cannot review or approve customer QMS documents.
Validation documents reach the customer within a day or two of kickoff. Qualio says the approach “has been accepted by all types of auditors.”

Validation files sit in a Qualio Dropbox, which Qualio treats as an approved supplier (Validation Resources, 23 May 2026). The root holds three folders: Feature Val Packs (one per launch train, by month and version; use the latest), Support Documentation, and Qualio Policies & Certifications. The policies folder includes a Qualio Supplier Folder and: POL-14 Data Security, Backup & Redundancy v20.0; POL-15 Software Development Life Cycle v19.0; POL-42 Disaster Recovery v14.0; POL-51 Change Management Policy v12.0; POL-53 Validation Policy v6.0; QR-23 Multitenancy Memo v2.0; QR-3 Risk Assessment & Management Plan v15.0; QR-79 21 CFR Part 11 Compliance Assessment v4.0; QR-80 Annex 11 Assessment v3.0; QR-83 ISO Certificates v4.0; SGS certificates for ISO 9001 (07.AUG.2025), ISO/IEC 27001 (25.AUG.2025), ISO/IEC 27701 (11.AUG.2026), and ISO/IEC 42001 (12.23.25); and SOP-94 Software Design & Development v3.0.

9. Customer evidence

Account	What is public	Source type
Insightra Medical, Clarksville, TN	CAPA and complaint records kept in Qualio; FDA warning letter, 3 June 2025 (section 3).	Regulator record
Medable, Paula’s Choice Skincare, Proscia, Ginkgo Bioworks	Named as customers in the 25 May 2021 release.	Press release
ArcScan, FifthEye, 4G Clinical	Named by Fenton, 25 May 2021. FifthEye CEO Jeffrey B. on the homepage: “best balance of price, capability, and quality of support.”	Vendor post and homepage
Homepage testimonials	Paul H. (Advantice Health), Thais S. (Cergenx), Gene V. (Cirris), Dmitry F. (ViQi), Karen H. (30 Technology: contact in November, live mid-December, users in January, ISO 13485 in July), Chris R. (AGADA Biosciences), Phil C. (Bond Digital Health), Drew M. (ECM Therapeutics), Mike T. (xCures), Peter B. (Watchmaker Genomics: license cost “insignificant” against process savings), Jackie L. (Auxilio Pharmaceuticals), Jeffrey B. (FifthEye), Sara V. (Leaseir), Michael H. (TriMed), Heather U. (EvoEndo), Daniel A. (InVivo Bionics). Title-and-company quotes: Synthego, Dimension Therapeutics, Akadeum, KUBTEC (MDSAP recertification), VirTrial, SimBioSys, Expression Therapeutics, NeuFit, Restech, and a JMP Securities finance title.	Vendor homepage

The 2024 terms let Qualio list customer names and logos.

10. Competitive and third-party context

The Insightra warning letter is the main independent record naming Qualio. Qualio displays a G2 rating of 4.7/5 from 667 reviews. No Gartner or Forrester report on Qualio was retrieved; their reports are paywalled.

11. Changes, renames, and research status

2012: Fenton founds Qualio.
First half of 2020: $11 million Series A.
25 May 2021: $50 million Series B led by Tiger Global.
14 July 2021: master subscription terms (Mitchelstown office, euro default, 1.5 percent late interest).
9 December 2022: current SLA.
13 August 2024: current terms (Dublin office; Qualio Plus, beta features, third-party AI, Amazon QuickSight; 2.0 percent late interest).
3 June 2025: FDA warning letter to Insightra names Qualio as its quality-record system.
August 2025: SGS certificates reissued, valid to 7 August 2028.
15 July 2026: current DPA.
2026: repositioned as the “Agentic Compliance Platform”; company page cites eight funding rounds and six pillars.

An FDA warning-letter search on 2 Oct 2026 found no letter issued to Qualio or Everworks; the one letter that names Qualio, to Insightra Medical, names it as that firm's quality system. Qualio publishes no RPO, RTO, or hosting region.

12. Source library

Full URL list, discovery method, and file-retention decisions: ../sources/qualio-sources.md.

Claim-level records: ../evidence/qualio.evidence.jsonl.

Primary pages:

1. Overview

What it is not:

Not an MES, batch-record, or equipment-control system. Qualio’s product, pricing, and integration pages describe no shop-floor execution, electronic batch records, or machine integration.
Not an ERP or LIMS. The integration catalog has no ERP or LIMS connector.
Not a substitute for legal obligations. The July 2021 and August 2024 terms both say the platform is a quality-management tool and not a substitute for standards required by law (Terms, effective 13 Aug 2024; Terms, effective 14 Jul 2021).
Not Qualio Plus. The 2024 terms define Qualio Plus as proprietary content (policies, SOPs, work instructions, templates, training decks) sold with a service.

2. Company and product identity

Point	Fact	Source
Legal entity	Everworks Limited, trading as Qualio, incorporated in Ireland, company number 508152.	2024 terms clause 1.2; 2021 terms clause 2.1
Registered office	2024: 13-18 City Quay, Dublin D02 ED70. 2021: Westlodge, Deerpark, Mitchelstown, Co. Cork, with formal notices to City Quay.	2024 terms clause 1.2; 2021 terms clauses 2.1, 13.2
Governing law	Irish law; Irish courts have exclusive jurisdiction, with a carve-out for Qualio to enforce an Irish order elsewhere.	2024 terms clause 16.4; 2021 terms clause 13.3
Founding	Fenton, 25 May 2021: “When I founded Qualio in 2012.” The same-day release names him Founder and CEO, datelined San Francisco.	Fenton post; PR Newswire, 25 May 2021
Series A	$11 million, first half of 2020 (Fenton: “our $11M Series A raised during the first half of 2020”).	Fenton post; PR Newswire
Series B	25 May 2021: $50 million led by Tiger Global, with Menlo Ventures. Existing investors per the release: Frontline Ventures, MHS Capital, Operator Partners, Sorenson Ventures, Storm Ventures. Fenton’s post omits Operator Partners. The release says “To date, Qualio has raised more than $63 million.”	PR Newswire; Fenton post
Later funding	Company page: “We’ve secured 8 rounds and over 60 million dollars of investment.” No round list.	Company page
Leadership	Robert Fenton, Founder and CEO. Mirko Hallenberger, Finance. Kevin Duggan, Engineering and Product. Suresh Balasubramanian, Marketing.	Company page
Workforce	2021: “all-remote,” with teammates in the San Francisco Bay area and customers “in 19 countries.” 2026: “globally distributed team.”	PR Newswire; Fenton post; company page
Former name	CB Insights lists ZenDoc as a former name. Qualio’s company page, 2021 posts, and terms do not use it.	Search index
Product name	Qualio, with no published version brand.	Homepage; terms

3. Pharma, biotech, and device relevance

Pharma positioning. Qualio’s pharma page says the software supports FDA, EMA, ISO, ICH, and GxP requirements, with workflows for documents, training, change control, suppliers, events, and audit trails, and names CAPA, deviation, and OOS tasks (Pharma solution page).
FDA warning letter naming Qualio at a customer. On 3 June 2025 CDRH issued a warning letter to Insightra Medical Inc. (Clarksville, Tennessee) about the Double Pump and Ultra IABP catheter kits. FDA quotes the firm’s SOP-15 (CAPA, effective 26 October 2022): CAPAs “are generated and documented in the Qualio system, an electronic record system used by your firm to manage quality documents.” Complaint CMP-44 went into “the Qualio database” on 29 February 2024 after receipt on 22 January 2024; CMP-36 went in on 4 December 2023 after the firm learned of it in October 2023. Insightra’s 14 February 2025 response said “the Qualio software will be modified to include a provision for closure time justification” for complaints open more than 30 days. FDA called the response inadequate. The cited violations are Insightra’s (FDA warning letter CMS 706921).
21 CFR Part 11. Qualio’s validation FAQ (updated 3 October 2025, Susan Griffith) says the validation pack includes a Part 11 assessment. It reminds customers that 21 CFR 11.100(c) requires the customer to certify its electronic signatures to FDA, and gives the Rockville mailing address (Validation FAQ).
ISO certificates. Qualio’s public PDF holds three SGS North America certificates, signed by Viq Mohammed, Director of Technical Accreditation, addressed to 268 Bush Street #3334, San Francisco, CA 94104 (ISO PDF):
1. ISO 9001:2015, US20/819944173, issued to “Qualio.” Scope: development of a SaaS cloud-based eQMS and governance, risk, and compliance platforms by a fully remote workforce. Valid 7 August 2025 to 7 August 2028. Issue 3. Certified since 23 December 2020.
2. ISO/IEC 27001:2022, US22/00000047, issued to “Qualio, Inc.” Scope: the ISMS for customer information and intellectual property related to the SaaS platform, per Statement of Applicability version 3.0 (July 2025), fully remote workforce. Valid 6 August 2025 to 7 August 2028. Issue 4. Certified since 9 August 2022.
3. ISO/IEC 27701:2019, US25/00000319, issued to “Qualio, Inc.” Valid 6 August 2025 to 7 August 2028. Issue 2. Certified since 6 August 2025. Its scope page is not in the public PDF.
The July 2026 DPA says Qualio holds 27001, 27701, 9001, and 42001, with certificates on request (DPA). The certificates name Qualio or Qualio, Inc. in San Francisco; the 2024 terms name Everworks Limited in Dublin.
Frameworks. Foundation includes 3 frameworks and Growth 5, labeled “FDA, MDR, ISO, GxP.” Extra frameworks cost more.

Vendor counts:

Homepage: “Trusted by 700+ highly regulated customers across the globe.”
PR Newswire, 25 May 2021: “more than 250 customers” across medical device, pharmaceutical, biotech, and contract service providers, naming Medable, Paula’s Choice Skincare, Proscia, and Ginkgo Bioworks; “more than 260 percent revenue growth year-over-year,” no baseline given.
Fenton, same day: “250 inspirational customers,” “100 amazing teammates,” trust “in 19 countries,” with ArcScan, FifthEye, and 4G Clinical as examples.
Homepage: “80% reduction in audit prep time | 5x ROI in 2 months | 60% lower consultant spend,” with no study cited.
Homepage: “G2 4.7/5” from “667 reviews.”

4. Capabilities

Capability	Plan status	What Qualio says	Source
Document control	Plan feature	“Build, distribute, and store quality documents with version control and approval workflows.”	Pricing page
Training management	Plan feature	“Standardize and automate training compliance.”	Pricing page
Supplier quality	Plan feature, configurable	“Centralize supplier oversight.”	Pricing page; validation FAQ
Quality events (CAPA, deviations)	Plan feature	“Configure and run action workflows for quality events.” The row shows “5 templates” (Foundation) and “Unlimited” (Growth) by column order.	Pricing page
Design controls	Plan feature, configurable	“Manage product lifecycles from ideation to final delivery.”	Pricing page; validation FAQ
Resource library	Plan feature	Imports data objects (batch numbers, equipment, customers, products) and links them to events.	Pricing page; integrations
Reporting	Plan feature	“Detailed dashboards and analytics.” The 2024 terms name Amazon QuickSight and let Qualio withdraw it, which ends customer QuickSight access.	Pricing page; 2024 terms clause 10.7
Frameworks and gap analysis	Plan feature	Foundation 3 frameworks, Growth 5, more for a fee. Homepage: AI gap analysis, evidence cross-mapping, monitoring.	Pricing page; homepage
Qualio Copilot and AI	Plan feature	Copilot, gap analysis, documentation mapping, remediation guidance, automated evidence collection, and continuous monitoring under “Agentic Compliance Capabilities.” The 2024 terms say services are “powered in part” by third-party machine-learning models Qualio chooses, that output can be inaccurate, that the customer must review it, and that Qualio disclaims liability. Beta features are “as is,” not for production, and can be withdrawn.	Pricing page; 2024 terms clauses 4.7, 10.6, 11.5
E-signatures and audit trail	Validation documentation	Part 11 assessment in the validation pack.	Validation FAQ
Backend customization	Not offered	“Nothing in the platform backend can be customized for individual customers by the customer or Qualio engineers.”	Validation FAQ

The company page lists “six pillars of quality” as Qualio’s model of a quality system. In 2021 Fenton wrote of “twelve pillars.”

5. Architecture and deployment

Hosted SaaS. The 2024 terms describe an “online, hosted quality management platform” used through the customer’s own device and internet connection (clause 3).
Multi-tenant, single application. The validation FAQ says Qualio is “a web-based, multi-tenant system that runs identically for all customers,” with “only one application running.” Customer data is “segregated logically in the software instead of physically with hardware.” Production and sandbox “are using the same application and database” with segregated data; sandbox configuration does not carry into production. Customers generally cannot decline functional updates. Some features sit behind feature flags.
Versions. Every deploy is a release, and the in-app version number is the release date (example: 22 December 2021). The FAQ records an ISO 13485 auditor objecting to the lack of a conventional version number; Qualio answers that each version traces to its code.
Hosting (DPA Exhibit C). Production runs on Amazon Web Services; Qualio operates no data centres. Data at rest uses AES-256 or equivalent. Privileged production access requires multi-factor authentication; shared accounts are prohibited. Systems span multiple availability zones. Backups are encrypted and stored separately. RTO and RPO are “defined and tested,” with no numbers or region published. An independent firm penetration-tests production annually. Exhibit C is headed “Qualio, Inc.,” while the DPA’s contracting party is Everworks Ltd.
SLA (SLA, last updated 9 December 2022). Support hours: Monday to Friday 6 am–5 pm Pacific (excluding US holidays), 8 am–6 pm GMT, and 8:30 am–4 pm Australian Eastern (excluding local holidays). Routine tickets are acknowledged within 24 business hours. Backups run at least daily, encrypted, with recovery tested at least yearly under Qualio documents POL-14 and POL-42.
Availability. Target of 99.9 percent per month, on commercially reasonable efforts; scheduled maintenance is excluded. Service credits against future fees: 10 percent below 99.9 (to 99.0); 15 percent below 99.0 (to 98.5); 20 percent below 98.5 (to 98.00); 25 percent below 98.00 (to 97.50); 40 percent below 97.50 (to 95.00); 50 percent below 95.00. Exclusions: force majeure, internet beyond Qualio’s demarcation, acts of the customer or third parties including the hosting provider, equipment outside Qualio’s control, and suspension under the agreement.
Severity targets. Severity 1 (down, no workaround): acknowledge in 1 hour, workaround in 4 hours, permanent fix in the next suitable window or emergency maintenance. Severity 2 (wrong results): acknowledge in 2 business hours, workaround in 1 business day, fix in 5 business days. Severity 3 (minor): acknowledge in 24 business hours, workaround in 3 business days, fix in the next scheduled release. Unclassified issues are Severity 3. Contact: support@qualio.com.
Data processing (DPA, effective 15 July 2026). Everworks Ltd, trading as Qualio, is processor. Laws named: CCPA/CPRA, GDPR, the Swiss Federal Act of 19 June 1992, and the UK Data Protection Act 2018. Qualio commits not to sell personal data or use it outside the business purpose. The subprocessor list is inside the product only. New subprocessors trigger notice and a 30-day objection window; if unresolved after another 30 days, the customer can terminate the affected service for a pro-rated refund. EEA, Swiss, and UK transfers use EU standard contractual clauses under Irish law; UK transfers use the ICO Addendum B.1.0 (laid 2 February 2022). No special-category data is transferred. Data is deleted within 30 calendar days of termination, with a deletion certificate within 30 days of request. DPO: Edda Pernice, privacy@qualio.com. Customers can audit after an incident, on reasonable belief of noncompliance, at a regulator’s request, or once a year, at their own cost. Material vulnerabilities are fixed within 90 days unless otherwise agreed.
Deployment options. Cloud subscription only. Qualio offers no on-premise or private-cloud option on its pages.

6. Integrations

Kind	What Qualio documents	Depth
Core, included	SSO, OneDrive, and Jira at no additional cost. The integrations page also lists Azure AD, Google Suite, and Okta.	Named connectors
Integration Hub (Foundation add-on)	GitHub, Azure DevOps, Intercom, TestRail, Zephyr Scale, Asana, Xray, GitLab, plus the core three. The page says the add-on unlocks the dev-tools catalog “with 2 integrations” and shows the longer logo list. On Growth it unlocks the full catalog with 3 integrations.	Plan-gated
CRM and support (Growth)	Salesforce (accounts, opportunities, cases), HubSpot (issues into events), Zendesk (tickets into quality events), Intercom (conversations into complaints), Microsoft Dynamics (complaints and adverse events), Linear.	One-way sync descriptions
Design-control feeds	Jira, Asana, Azure DevOps, TestRail, GitHub, GitLab, Xray, and Zephyr Scale feed requirements, tests, or trace matrices into Design Controls.	Marketing descriptions
Training	ComplianceWire receives Qualio documents.	One connector
Developer API	Listed on the pricing page. The validation FAQ says the API changes how data enters, not application behavior; customers validate their API configuration. No public API reference.	Exists
AI-to-system protocol	“Open protocol for AI-to-system communication,” marked “coming soon.”	Not released
ERP, LIMS, MES	None in the catalog.	None

7. Pricing and commercial model

Pricing is quote-only; Qualio publishes no list price. The pricing page says “Request Pricing” and “Talk to us for a quote.”

Plans. Foundation: 5 edit users, unlimited basic users. Growth: 10 edit users, unlimited basic users. Scale: “custom pricing, custom implementation,” with dedicated success and support.
Implementation fee “applies to all plans.”
Subscription. Annual, recurring, including updates, cloud storage, and support, “with no hidden fees.”
Add-ons. Extra edit users, extra frameworks (“additional fee”), extra Growth instances for multiple sites or entities, and Integration Hub.
Services. Qualio Plus and professional services (onboarding, consulting) are priced on the order form (2024 terms clauses 2.8, 4.5, 4.6).
Order-form terms (2024 terms section 6). Fees follow what was purchased, not usage. Payment obligations are non-cancellable and fees non-refundable. Quantities cannot be reduced mid-term. Invoices are due in 30 days. After notice and a 10-day cure period, Qualio can suspend access and charge 2.0 percent monthly late interest (or the legal maximum, if lower). Overage bills at order-form rates. Qualio can audit usage. The 2021 terms set euro as the default currency and 1.5 percent late interest; the 2024 fee section names no default currency.
Confidentiality. The 2024 terms treat the order form, including pricing, as confidential.
Renewal. Qualio can set a new fee before renewal; the customer can refuse in writing at least 30 days before term end (clause 7.2).
Time to live. Pricing FAQ: “most customers are live within 30 to 60 days.” Homepage: “go live 2 weeks faster than traditional eQMS validation methods” and “Only 1% of our customers choose to validate themselves.”

Public money that is not a list price

Questions a buyer should ask

How does the order form define edit users versus basic users?
What does the implementation fee cover: migration, validation pack review, Qualio Plus content?
Which frameworks are included, and what does each extra framework cost?
Is Integration Hub in the quote, and which systems are in scope?
Are sandbox instances included, and are extra production instances priced per site?
Is there a cap on renewal increases?
Is acceptance of Qualio’s validation tests written into the order form?
Which AWS region holds production data, and what are the RPO and RTO numbers?
Which AI features are included, which model providers process customer text, and how are beta features kept out of GxP use?
What analytics remain if Qualio withdraws Amazon QuickSight?

8. Implementation and validation support

Validation approach (validation FAQ, 3 October 2025):

Qualio tests the shared application with CircleCI and GitHub and advises customers not to repeat functional testing.
Qualio cites FDA CSA guidance and ISPE GAMP 5 as moving away from routine IQ/OQ/PQ, and supplies test scripts customers can format as IQ/OQ/PQ on request.
Sion Wyn, described as editor of GAMP 5 and an FDA advisor, reviewed Qualio’s assurance approach.
The pack includes a Part 11 assessment. Default content tells customers to qualify Qualio as a supplier, write intended use, and state that the system adds no additional risk to product or patient safety.
Qualio staff cannot review or approve customer QMS documents.
Validation documents reach the customer within a day or two of kickoff. Qualio says the approach “has been accepted by all types of auditors.”

9. Customer evidence

Account	What is public	Source type
Insightra Medical, Clarksville, TN	CAPA and complaint records kept in Qualio; FDA warning letter, 3 June 2025 (section 3).	Regulator record
Medable, Paula’s Choice Skincare, Proscia, Ginkgo Bioworks	Named as customers in the 25 May 2021 release.	Press release
ArcScan, FifthEye, 4G Clinical	Named by Fenton, 25 May 2021. FifthEye CEO Jeffrey B. on the homepage: “best balance of price, capability, and quality of support.”	Vendor post and homepage
Homepage testimonials	Paul H. (Advantice Health), Thais S. (Cergenx), Gene V. (Cirris), Dmitry F. (ViQi), Karen H. (30 Technology: contact in November, live mid-December, users in January, ISO 13485 in July), Chris R. (AGADA Biosciences), Phil C. (Bond Digital Health), Drew M. (ECM Therapeutics), Mike T. (xCures), Peter B. (Watchmaker Genomics: license cost “insignificant” against process savings), Jackie L. (Auxilio Pharmaceuticals), Jeffrey B. (FifthEye), Sara V. (Leaseir), Michael H. (TriMed), Heather U. (EvoEndo), Daniel A. (InVivo Bionics). Title-and-company quotes: Synthego, Dimension Therapeutics, Akadeum, KUBTEC (MDSAP recertification), VirTrial, SimBioSys, Expression Therapeutics, NeuFit, Restech, and a JMP Securities finance title.	Vendor homepage

The 2024 terms let Qualio list customer names and logos.

10. Competitive and third-party context

11. Changes, renames, and research status

2012: Fenton founds Qualio.
First half of 2020: $11 million Series A.
25 May 2021: $50 million Series B led by Tiger Global.
14 July 2021: master subscription terms (Mitchelstown office, euro default, 1.5 percent late interest).
9 December 2022: current SLA.
13 August 2024: current terms (Dublin office; Qualio Plus, beta features, third-party AI, Amazon QuickSight; 2.0 percent late interest).
3 June 2025: FDA warning letter to Insightra names Qualio as its quality-record system.
August 2025: SGS certificates reissued, valid to 7 August 2028.
15 July 2026: current DPA.
2026: repositioned as the “Agentic Compliance Platform”; company page cites eight funding rounds and six pillars.

12. Source library

Full URL list, discovery method, and file-retention decisions: ../sources/qualio-sources.md.

Claim-level records: ../evidence/qualio.evidence.jsonl.

Primary pages:

1. Overview

2. Company and product identity

3. Pharma, biotech, and device relevance

4. Capabilities

5. Architecture and deployment

6. Integrations

7. Pricing and commercial model

Public money that is not a list price

Questions a buyer should ask

8. Implementation and validation support

9. Customer evidence

10. Competitive and third-party context

11. Changes, renames, and research status

12. Source library

Sources note

Sources: Qualio

Vendor and company

Press and third parties

Procurement

Regulators

1. Overview

2. Company and product identity

3. Pharma, biotech, and device relevance

4. Capabilities

5. Architecture and deployment

6. Integrations

7. Pricing and commercial model

Public money that is not a list price

Questions a buyer should ask

8. Implementation and validation support

9. Customer evidence

10. Competitive and third-party context

11. Changes, renames, and research status

12. Source library

Sources note

Sources: Qualio

Vendor and company

Press and third parties

Procurement

Regulators