Pricing

Audit-ready eQMS for regulated teams

From a free Pilot to multi-site Enterprise. Every plan includes the complete quality suite and the full validation pack — both CSV and CSA — at no extra cost.

Pricing is scoped to your deployment — request a quote, or download the validation pack first.

Choose the plan that fits your programme

Four plans, one platform. Compliance and the full validation pack are in every plan — including the free Pilot. Plans differ on the modules in production, the intelligence layer, your environments, and the depth of support — never on whether you can be compliant.

Free
Pilot · Try Complere free

Pilot

Free evaluation

For QA teams evaluating Complere in a real workflow before committing to a plan.

  • The complete quality suite to explore
  • CSV + CSA validation pack included
  • Item count capped per module while you evaluate
  • Self-serve — most teams decide within a 30-minute call
Start free
Foundation · Get audit-ready

Foundation

Five core modules

For small biotech, device, and CDMO teams preparing for their first regulatory submission or audit.

  • 5 core modules — Documents, CAPA, Events, Training, Audits
  • CSV + CSA validation pack included
  • Production + Sandbox + DR environments
  • SSO, MFA & next-business-day support
Request pricing
Enterprise · Premium assurance

Enterprise

Premium SLA & success

For large regulated organisations needing premium SLA, 24×7 Sev-1 response, a dedicated CSM, and quarterly business reviews.

  • Everything in Professional
  • Audit Confidence views
  • Premium SLA with service credits
  • 24×7 Sev-1 support + premium API tier
  • Dedicated CSM & quarterly business reviews
Request pricing
Every plan includes:
  • CSV + CSA validation pack
  • 21 CFR Part 11 e-signatures
  • Immutable ALCOA+ audit trails
  • Role-based access control
Compliance is never an upsell.

Why no sticker price? We scope each quote to what you actually run — your plan, the modules in production, your team size, and your environment and support needs — rather than a flat per-seat rate. The Pilot is free; Foundation, Professional, and Enterprise quotes come from a 30-minute scoping call.

Compare plans in detail

Every cell a buyer can quote back at us. Compliance and validation rows are identical in every plan — by design. For exact figures, request pricing.

  • Included
  • Included, capped for evaluation
  • Not included
Capability PilotFree FoundationCore ProfessionalMost popular EnterprisePremium
Compliance & validation — in every plan6 features
CSV validation pack — VMP, URS, IQ / OQ / PQ, traceability
CSA validation pack — FDA risk-based assurance
21 CFR Part 11 e-signatures
EU GMP Annex 11 alignment
Immutable ALCOA+ audit trail, per record
ISO 13485 record-keeping · GAMP 5 methodology
Quality modules10 features
Document Control
CAPA Management
Events / Deviations
Training & Competency
Audit Management
Change Control
Risk Assessments — ICH Q9 / ISO 14971
Supplier Management
Audit Confidence views
Modules availableEight quality modules in total Complete suite, capped 5 core modules Complete suite Complete suite
Compliance Intelligence5 features
Compliance CockpitSee every module's health at a glance
Obligation Registry & coverage mapKnow which controls cover which regulation
One-click Inspection PackHand an auditor a signed, reproducible evidence set
CSA Evidence Graph explorerTrace any record back to its requirement
Executive Compliance IndexOne score leadership can track over time
Platform & security6 features
Environments Production Prod + Sandbox + DR Prod + Sandbox + Val + DR Prod + Sandbox + Val + DR
Role-based access control
Multi-factor authentication
Single sign-on — SAML / OIDC, Azure Entra
Per-customer isolated infrastructure
Regional data residency options
Developer & integrations3 features
Developer API Read-only Full read / write Full + premium
Webhook integrations
Sandbox API for development
Support & success4 features
Time to liveFrom kickoff to your first controlled record ~1 week 2–4 weeks 4–8 weeks Phased rollout
Support response Self-serve docs Next business day Priority — business hours 24×7 Sev-1
Uptime SLAContractual availability commitment Best-effort Standard Enhanced Premium + service credits
Dedicated CSM + business reviews
Pilot Try Complere free

Complete quality suite, capped for evaluation · free

  • Full compliance layer — CSV + CSA packs, Part 11, ALCOA+, RBAC, isolated infra
  • The complete quality suite to explore
  • Production environment · self-serve docs
  • MFA · SSO · Compliance Intelligence · API · multi-env
Start free
Foundation Get audit-ready

5 core modules · Prod + Sandbox + DR

  • 5 core modules — Documents, CAPA, Events, Training, Audits
  • CSV + CSA validation pack · full compliance layer
  • MFA · SSO (SAML / OIDC) · read-only API · sandbox API
  • Next-business-day support
  • Change · Risk · Suppliers · Compliance Intelligence · Validation env
Request pricing
Enterprise Premium assurance & success

Complete suite + Audit Confidence · premium SLA

  • Everything in Professional
  • Audit Confidence views
  • Premium SLA with service credits
  • 24×7 Sev-1 support + premium API tier
  • Dedicated CSM + quarterly business reviews
Request pricing

One validation pack. Both approaches the FDA recognises.

Use the approach that fits your QA culture, your regulator, and your risk profile — or use both. Either way, it's included in every plan, with no add-on fees.

Traditional approach

CSV — Computer System Validation

The traditional, documentation-led approach: VMP, URS, IQ / OQ / PQ, test scripts, and traceability evidence. Defensible under any audit framework worldwide.

  • Best for established CSV practice and conservative auditors
  • Mature, fully documented regulated environments
Risk-based approach

CSA — Computer Software Assurance

The FDA's newer risk-based approach (draft guidance, Sep 2022). Test effort focuses on patient safety, product quality, and data integrity — lower documentation burden, same audit defensibility.

  • Best for modern QA programmes and faster validation cycles
  • Teams adopting the FDA's risk-based direction

Why teams pick Complere over enterprise suites

Pricing posture, not just pricing. What buyers compare when they shortlist Complere against Veeva Vault QMS, MasterControl, or TrackWise.

Scope

Pay for the plan you run

No 12-module enterprise SKU priced for a Top-20 pharma. Start on Foundation's five core modules, step up to Professional when you need Change, Risk, Suppliers, and the intelligence layer.

Validation

Both validation packs included

CSV and CSA — VMP, URS, IQ/OQ/PQ, traceability, and the FDA risk-based approach — shipped with every plan. Enterprise suites typically charge $25–50K separately or push validation to a partner.

Time-to-value

Start free, in days

The free Pilot is a real workflow in a validated environment, not a stripped sandbox. Most enterprise rollouts take 6–12 months before the first record is captured.

Compliance Frameworks Addressed

Every Complere deployment is built to support these regulatory frameworks and standards.

  • FDA 21 CFR Part 11Electronic records & signatures
  • EU GMP Annex 11Computerised systems controls
  • ISO 13485Medical device QMS records
  • GAMP 5Validation methodology
  • ALCOA+Data integrity principles

Frequently Asked Questions

Quick answers to the questions we hear most from quality leads, compliance managers, and IT teams evaluating Complere.

Is there a free version of Complere?

Yes. The Pilot plan is free for evaluation — your QA team can run a real workflow across all eight quality modules, with both CSV and CSA validation packs included, before committing to a plan. Item counts are capped per module during the evaluation. Most teams know whether Complere fits within a 30-minute scoping call.

How is Complere pricing structured?

Pricing is scoped to your deployment — the plan you choose, the modules in production, your team size, and your environment and support needs — rather than a published per-seat sticker price. The Pilot plan is free; Foundation, Professional, and Enterprise quotes are shared on a short scoping call so we can size the plan to what you actually put into production.

What is the difference between Foundation, Professional, and Enterprise?

Foundation gives you the five core quality modules — Document Control, CAPA, Events / Deviations, Training, and Audit Management — for teams preparing for their first submission or audit. Professional adds Change Control, Risk Assessments, and Supplier Management, plus the Compliance Intelligence layer, the developer API, and a dedicated Validation environment. Enterprise adds Audit Confidence views, premium SLA with credits, 24×7 Sev-1 support, a dedicated CSM, and quarterly business reviews.

Are both validation approaches really included at no extra cost?

Yes — every plan, including the free Pilot, ships with both validation approaches the FDA recognises. The CSV pack is the traditional, documentation-led approach (VMP, URS, IQ/OQ/PQ, test scripts, traceability). The CSA pack is the FDA's newer risk-based Computer Software Assurance approach, focusing test effort on patient safety, product quality, and data integrity. Use whichever fits your QA culture and your regulator — or use both. There are no add-on validation fees.

What is Compliance Intelligence and which plans include it?

Compliance Intelligence is Complere's analytics and inspection-readiness layer — the Compliance Cockpit, an Obligation Registry and coverage map, a one-click Inspection Pack, the CSA Evidence Graph explorer, an Executive Compliance Index, and an explainability panel on every score. It is included with the Professional and Enterprise plans.

Can I add users or modules later?

Yes. Additional users above your included count are billed at your in-tier rate up to a defined headroom; beyond that, you move up to the next plan. Modules and capabilities are activated without recompiling or redeploying, so you can expand scope as your quality programme grows. Talk to us to map the right starting plan.

Not sure which plan fits your programme?

Start free with the Pilot, or take a 30-minute scoping call — usually enough to map your modules, your compliance requirements, and the right plan. Want the figures? Request pricing and we'll size a quote to what you run.

Or download the validation pack first →

Audit-ready eQMS — validation included in every plan Start free Request pricing