Qualityze
AI-powered, Salesforce-native enterprise quality, safety, compliance and risk suite for regulated life sciences and manufacturing.
By Qualityze Inc. · HQ Tampa, US · 4.9/5 Value-Position score (estimate)
Positioning guardrails
Best for
- Regulated life sciences and manufacturing organisations wanting one EQMS spanning quality, EHS, supplier quality and product data.
- Salesforce-standardised enterprises that want quality workflows on the platform they already run.
- Quality leaders replacing manual CAPA, nonconformance, audit and calibration tracking.
- Multi-site, multi-standard operations that need validated, audit-ready releases.
Ideal size: 100–5,000 users people · Scale-up or enterprise with an established quality/compliance function and Salesforce or ERP in place
Not for
- Small teams wanting self-serve signup and published list pricing.
- Companies with no certification- or regulation-driven quality obligations.
- Buyers who want an outsourced quality service rather than configurable software.
Value metrics scorecard
Time-to-Value
Guided onboarding; roughly 3 months
~90 days to first production value
Total Cost of Ownership
On request
Custom quote, modular a-la-carte: priced by modules, users, sites and services selected; no published list price.
Implementation Friction
4/5
Engineering + admin effort required
Value-Position score
out of 5 · model estimate
Full cost breakdown
Mandatory implementation fee
None
Seat tiers
No published seat tiers; quotes are built per user count and site count.
Add-on costs
- Deployment and validation services are quoted as itemised line items alongside modules, users and sites.
Company & support
Who is behind Qualityze, and how your team gets help once it is live.
Company
- Founded
- 2015 · 11 yrs in business
- Headquarters
- Tampa, US
How you get support
- PhoneNot listed
- EmailNot listed
- Live chatNot listed
- Support portal / ticketsPaid plans
- Community forumNot listed
- Help centre / docsPaid plans
- Dedicated account managerNot listed
- In person / on-siteNot listed
- Hours
- Not recorded
- Response time
- Typically respond within one business day
Support requests are routed through the vendor's contact form by product area; subscriptions include user guides and an on-demand tutorial library, plus access to the Qualityze support team.
“Not listed” means the vendor’s public pages don’t mention that channel, not that it is unavailable. Ask about it during evaluation.
Market position
Where Qualityze sits against its closest alternatives. Pick any two of cost, speed, friction and buyer score, and up to 9 companies to compare.
Quadrant view
Typical annual cost × Time-to-value
The lines cross at the median of the solutions shown, so about half sit on each side of each line.
Companies on the chart 6 / 10
- Qualityze
- Kiteworks
- Verifiable
- Dot Compliance
- Ataccama ONE
- Exabeam
Add or change companies
Up to 10 companies including Qualityze. Listed closest first.
Stack fit signal
Compatibility with standard B2B ecosystems.
No supported MCP path today, so it cannot be driven from an AI client.
AI & MCP readiness
What Qualityze ships in AI, and what it asks of your ecosystem.
AI features shipped
Homepage describes Q, a conversational AI assistant embedded in quality processes, plus seven purpose-built AI agents (QMS, EHS, SRM, Asset, PDM, PMS, CI) that analyse connected records, surface recurring issues, prioritise high-risk events and recommend next-best actions. No source states model providers, key model, AI audit logging or AI training practices.
Your data & models
- Trains on your data
- Not recorded — ask the vendor
- Runs on
- Not recorded
- AI pricing
- Not recorded
In your ecosystem
- AI connection
- Not supported
- Model key
- Not recorded
- AI usage audit
- Not recorded
Compliance attestations
* IAPP AIGP certifies individuals, not products. It means named staff hold the credential — not that the platform does.
Bottom line
Qualityze is a Salesforce-native, AI-powered enterprise quality management suite for life sciences and regulated manufacturing. It unifies QMS, EHS, supplier quality, product data, asset, post-market surveillance and continuous improvement modules, with agentic AI agents for next-best actions, prioritisation and conversational reporting. Compliance frameworks include ISO 9001, 21 CFR Part 11, ISO 13485, IATF 16949 and AS9100. Pricing is quote-based and modular; implementation is guided.
Frequently asked questions
What is Qualityze and who is it built for?
Qualityze is a Salesforce-native enterprise quality management suite covering quality, EHS, supplier quality, product data, asset, post-market surveillance and continuous improvement. The vendor targets life sciences and regulated manufacturing, citing frameworks such as ISO 9001, FDA 21 CFR Part 11, ISO 13485, IATF 16949 and AS9100, and says it is trusted by Fortune 500 companies across 20+ industries.
How is Qualityze priced?
There is no published list price. Qualityze says pricing scales with the modules, users, sites and services you choose, with an itemised quote built around your scope. Platform updates, validation packages for each update, guided onboarding and training, Salesforce infrastructure and support are stated as included rather than charged separately, and there are no per-record or per-transaction fees.
Which regulations does Qualityze support?
The vendor highlights ISO 9001:2015, US QMSR, 21 CFR Part 11, AS9100/IAQG 9100, IATF 16949, ISO 45001, ISO 14001, ICH Q10, GDPR and HIPAA, and maps industries to frameworks such as ISO 13485, GMP, FSMA, API Q1 and 21 CFR Part 820. Part 11 support covers electronic records, controlled workflows, audit trails, role-based access and e-signature validation.
How long does implementation take, and is it included?
Qualityze says everything starts with guided onboarding and program implementation backed by a dedicated team, with milestones, costs and timelines set against your program goals. Validation packages ship with every release so compliance posture keeps up with updates. The vendor does not publish a standard implementation timeline, so duration and scope are agreed as part of the tailored quote.
What AI capabilities does Qualityze include?
Qualityze embeds agentic AI it calls Q across quality processes. Stated capabilities include next-best-action recommendations, prioritisation of CAPAs, investigations and risks, proactive risk alerts, conversational reporting in natural language, AI root-cause correlation, and seven purpose-built agents for QMS, EHS, supplier, asset, product data, post-market and continuous improvement work. No model providers or AI training practices are disclosed.