Pricing
eQMS pricing by organization tier, with every module included
QMSdesk™ eQMS pricing is set by the size of your organization, never per seat. Every tier includes every module, and growing past your band never locks anyone out.
Three tiers, every module
Everyone in. No one locked out.
Early-Stage & Startup
1–25users
Every module
For teams building their first regulated quality system, or moving one off paper. Early-stage and growth teams can apply for the 2026 Early Adopter Program.
Growth & Mid-Market
26–250users
Every module
For teams running quality across departments, products or sites, where operators, supervisors and quality all work in one system.
Enterprise & Multi-Site
251+users
Every module, unlimited users
For organizations running quality across many sites, with site tokens in numbering, site scope in search and commercial terms by agreement.
How eQMS pricing works at QMSdesk
Priced by tier, never per seat
Your tier follows your organization's size, so the operators who record events can be in the system without anyone counting licenses.
Every module in every tier
No module, service or feature on this page is held back for a higher tier.
The seat limit is advisory
If you grow past your band, nobody is locked out. It becomes a conversation about your next tier.
Your records stay yours
If a module is ever suspended, every record in it stays readable and exportable.
Bring in only what you're ready for
Audits or supplier management can be marked "managed outside QMSdesk" until you move them in.
Suppliers never need a seat
They answer corrective-action requests through a single-use link, with no account.
The platform, and the services around it
Your subscription covers the whole platform. Implementation, migration and validation support are scoped separately, in writing, before you sign.
02
Managed deployment
Akatalyst's practitioners deliver the rollout end to end: data migration, validation support, SSO, UAT and hypercare.
03
A written validation scope, every time
QMSdesk's core platform is validated under a QA-approved Validation Summary Report, and your system is validated by you. We'll walk you through the full record under a mutual NDA. Every engagement includes a written validation scope, so you know exactly what's done and what remains yours. See how QMSdesk is validated
The target for a first working workflow is 8–12 weeks, depending on scope, data readiness and your team's availability.
Total cost of ownership
QMS software cost, over five years
Both are positioning estimates, not results measured at a customer. Your proposal sets out your own figures. Model your 5-year cost
No tier holds anything back
Included in every tier
Every tier includes all 10 modules and all 7 platform services:
Modules
- Document control
- Quality events
- CAPA
- Change control
- Training and competency
- Risk management
- Audit management
- Supplier quality
- Management review
- Reporting and analytics
Platform services
- Audit trail and e-signatures
- Regulatory profiles
- Workflow engine
- Implementation and go-live
- Access and governance
- Records and retention
- Integration
See the complete list of everything included
Document control
- Lifecycle: Draft, then Review, then Approval, then Approved, then Effective, then Superseded, Obsolete or Retired
- Signatures at authoring, review and approval
- Reviewers request changes (an attributed comment) or reject (a signed finding); any return goes back to Draft for full re-review
- Author, reviewer and approver kept separate at signing; two independent approvers for high-criticality documents
- Effective-date grace period, 14 days by default, with a signed early release
- Training assigned when a document is approved
- Controlled-copy PDF with a "CONTROLLED COPY" banner and signature log
- Downloads logged, and blocked if logging fails
- Typed cross-references, a "Referenced by" view and stale-reference flags
- Periodic review tasks; a risk opens after 30 days overdue
- Reference documents (standards, guidance, CVs, quality agreements) with provenance, currency checks and a "not internally approved" banner
- Restricted documents hidden from lists, search, counts and exports for anyone without rights
- Licensed standards viewable in the app, with download suppressed
- Author in the editor or upload a source file
- Migration import with one signed attestation per batch and a permanent "Migrated" badge
Quality events
- Six event workflows: incident, deviation, nonconformance, complaint, OOS/OOT and supplier issue
- Anyone can report an event; control applies from triage onward
- Deviations routed by severity: minor on a short path with one signature; major and critical through containment, investigation, a signed CAPA decision and QA approval
- Nonconformance disposition signed: reject, rework, use-as-is (with technical rationale) or return
- Incident containment required for major and critical incidents
- Complaints: acknowledgment tracked against a 3-business-day SLA, a signed reportability review, a signed CAPA decision and a customer response
- OOS/OOT: a mandatory two-phase investigation following FDA's 2006 OOS guidance
- Supplier issue (SCAR): signed response review, verification and closure that sets supplier status
- Profile workflows: GLP study deviation, GLP QAU finding, and patient safety event (always raises a CAPA)
- Profile event types, from batch deviation and MDR vigilance to protocol deviation and ATMP process nonconformance
- Records raised in error cancelled with a signed reason, never deleted
- A missed deadline escalates but never blocks; a late step records its delay reason
- Closure Record PDF with the full signature manifest, available once an event closes
CAPA
- A peer of change control, raised from an event, a trend, an audit or a management review
- Lifecycle: Reported, then Investigation, then Action plan review, then Implementation, then Verification, then Closed
- Effectiveness verification that can't be skipped
- Action items, each with its own evidence and QA review (Moderate, Major and Critical CAPAs)
- The investigator can't sign the action-plan review
- The approved action plan raises the linked change control and training
- Scheduled effectiveness checks after closure, over the interval you set
- A failed check raises a new, linked CAPA; the signed one is never reopened
- A critical risk raises its CAPA automatically, once
- An event's CAPA is raised by its signed CAPA decision, in the same transaction
Change control
- Lifecycle: Draft, then Triage, then Assessment, then Approval, then Implementation, then Verification, then Closed, with On hold, Rejected and Cancelled
- Risk-based approval routing: high-impact changes go to the Change Manager and the Quality Manager
- Classification can raise the tier but never lower it
- Approvers can be added, never removed
- The requester can't approve; the implementer can't verify
- Change actions for implementation
- Post-go-live configuration changes run as ordinary change controls
Training and competency
- Four ways to complete: signed acknowledgment, quiz graded against a frozen snapshot, practical assessment signed by a qualified assessor, external certificate
- Automatic assignment on document approval, change implementation, CAPA plan, new hire, role change and department change
- Recurring refreshers, overdue flags and digests
- Signed, time-limited waivers and equivalencies
- Competency assessments by qualified assessors
- Overdue training for a GxP-critical role opens a risk
- Training transcripts per person
Risk management
- Lifecycle: Identified, then Assessed (signed), then Mitigation planned, then Mitigated (signed residual), then Monitoring, then Accepted (ALARP, signed) or Closed
- Likelihood × impact on a 5×5 matrix, or FMEA RPN
- Your own thresholds on the 5×5 matrix
- Severity dominance: a maximum-severity risk never scores below High
- Built on ISO 14971 and ICH Q9 principles
- ISO 14971 control model: implementing and verifying kept separate, residual risk scored only after verification
- Control taxonomy following ISO 14971 §7.1, and new hazards from a control raised as risks
- Built-in risk templates, plus your own
- Risks opened automatically by an expired supplier certificate, a document review 30 days overdue, or overdue GxP training
- An ineffective CAPA sends its risk back for re-assessment
Audit management
- Lifecycle: Planned, then Scheduled, then In progress, then Completed (lead auditor signs), then Approved (management signs), then Closed
- Auditors can't audit their own department; the lead auditor can't approve their own report
- Critical findings raise a nonconformance and a risk; major findings raise a nonconformance; optional linked CAPA
- One register of findings across every audit
- Opportunities for improvement and positive observations, without finding consequences
- Audit program, calendar, templates and auditor qualification profiles
- Inspection View: time-boxed, read-only accounts for inspectors that can still export, with every access logged
Supplier quality
- Lifecycle: Prospect, then Under evaluation, then Conditionally approved or Approved, then Active, then Suspended or Disqualified, with signed decisions
- Risk tiers (Critical, Key, Standard) set qualification gates, completeness gates and 6-, 12- or 24-month reviews
- Approved Supplier List, with conditional approvals marked
- Certificate expiry alerts at 90, 60 and 30 days, and a risk opened on expiry
- Periodic re-evaluation tasks and a supplier scorecard
- Two rejected SCAR responses raise the supplier to the Critical tier
- Single-use SCAR link: no account, no seat, two fields to answer, expires on use, attributed in your audit trail
Management review
- A signed, frozen snapshot of the quality system as of the period end, never edited or recomputed
- Reviews scheduled, run and closed, with minutes and decisions signed at closure
- Follow-up actions assignable after closure
- SoD waivers included in the review pack automatically
Reporting and analytics
- Command Center with five views: Executive Pulse, Inspection Readiness, Risk Command, Training Intelligence and Notification Activity
- Every figure opens the records behind it
- My Work: each person's open tasks, deadlines and activity
- Review queue: everything awaiting your signature, across modules
- Global search that respects permissions and site scope
- Event trending by type, severity, site, product and root cause, with OOS lab-error trends by method, analyst and instrument
- PDF and Excel reports, plus weekly scheduled reports
- In-app inbox as the system of record; notifications never deleted
- Navigation grouped into My Work, Operations, Oversight and Administration
- Reminders before a due date, then widening escalation to coordinator and Quality Manager
Audit trail and e-signatures
- Every audit-trail entry SHA-256 hash-chained to the one before it
- Audit-log immutability enforced at the database layer
- Daily chain verification, on demand too; only a genuine break fails
- Daily check that every signature still resolves to its record
- Signed periodic audit-trail review over a risk-focused view
- A controlled vocabulary of signature meanings
- Re-authentication on every signature, with MFA where required
- Signature and record change committed in one transaction
Regulatory profiles
- 12 profiles, built from a registry of 27 regulations, standards and guidelines
- Profiles chosen directly at onboarding, several at once
- Event types, roles and required fields combined; longest retention, shortest deadline
- Electronic signature wherever any profile requires it
- Add-only for the life of your tenant
Workflow engine
- Eight connected quality objects: document, event, CAPA, risk, change, audit, training and supplier
- One versioned definition per workflow, read alike by the interface, API and validator
- Each step declares its required fields, electronic signature and SLA
- Steps and transitions locked; direct status writes rejected
- A daily check flags any live workflow behind its current definition
- New required fields apply to new records only
- Decision-driven cascades committed in the same transaction as the signed decision
- Typed, attributed links between any records; a removed link is kept
- Cascades into a module managed elsewhere suppressed and logged
- 18 scheduled compliance jobs
- Configurable numbering by prefix, year, site, department and counter, never reissued
Implementation and go-live
- Six-stage Configuration Runway
- Implementation Mode: modules locked during setup, a banner for every role
- Testing in your real tenant, with the records kept as evidence
- Implementation-era data kept out of live KPIs, and watermarked on PDF reports
- Go-live gate with evidence-based checks and two signed attestations
- Change control on validation-affecting settings after go-live
- Document migration with a signed batch attestation
Access and governance
- 9 core roles, plus the roles each profile adds
- Authorization checks a permission key, never the role name
- The Administrator holds no record-approval authority
- Segregation of duties checked when each signature is applied
- Time-bound SoD waivers; the beneficiary can't approve their own
- Break-glass access: granted, logged, time-boxed, reviewed, and never able to sign
- Delegations for cover and periodic access reviews
- Vendor support access: at most 7 days, visible to you, second-operator authorized, never able to sign
- Custom roles through the API, with no self-escalation and signed changes
- One person per account; user IDs never reissued
- Password history, lockout, MFA by tenant or role, an inactivity timeout and a maximum session length
- Tenant isolation by row-level security in the database
Records and retention
- One retention clock per tenant, at the longest floor your profiles set: 7, 10, 15 or 30 years
- Archived at the end of retention, never hard-deleted
- Audits or suppliers can be marked "managed outside QMSdesk"
- A suspended module stays readable and exportable
- A signed System Boundary Statement, available at any time
Integration and tenant
- SAML 2.0 single sign-on with Okta, Microsoft Entra, Google Workspace or custom SAML
- REST API for audits, changes, documents, events, risks, suppliers and training
- OAuth client credentials, API keys and OpenAPI documentation
- Site tokens in numbering, and site scope in search
- Your logo in the app and on controlled-copy cover pages
- A custom sign-in domain, set up by our team
Limited cohort
The 2026 Early Adopter Program
The 2026 Early Adopter Program is for early-stage and growth teams starting their eQMS now: an early adopter rate 60% below the standard subscription, held for your contracted term, for a limited cohort of 15 organizations. Applications close December 31, 2026.
Questions buyers ask
How much does QMSdesk cost?
We quote each organization directly, by tier. Your proposal sets out the tier, the services you choose and your written validation scope together. Request a proposal.
What happens if we grow past our tier?
Nobody is locked out. The seat limit is advisory, so everyone keeps working while we agree your move to the next tier.
Are any modules sold as add-ons?
No. Every module and platform service listed on this page is in every tier. Tiers differ only by organization size.
Is implementation included?
Your subscription covers the platform. Implementation, migration and validation support are scoped separately, in writing, before you sign. You can walk the Configuration Runway yourself with our support, or have Akatalyst deliver the rollout.
What happens to our records if a module is suspended?
Every record in it stays readable and exportable.
Do suppliers need a seat?
No. Suppliers answer corrective-action requests through a single-use link, with no account and no seat, and each response is attributed in your audit trail.
Can we try QMSdesk first?
Yes. Bring one of your own workflows to a demo, and we'll run it in QMSdesk with you.
Everyone in. Every module. One tier that fits.
Tell us how many people will use QMSdesk and which regulations you work under, and we'll send a proposal with your tier, services and validation scope.