Qualcy is an AI-powered QMS for pharma, biotech, and medical device firms - document control, CAPA, audits, training, and FDA compliance in one platform.
Category
ERP & Business Management
Pricing
Monthly subscription billed per admin user, in three tiers: Basic $99/mo (6 modules), Gold $129/mo (8 modules), Platinum $149/mo (10 modules); optional backup/maintenance add-on $299-$449/mo and reduced-permission basic-user seats $21-$39/mo; no free trial advertised.
Verified
Not yet
Last updated
August 6, 2026
SaaSSubscriptionReportingAICloud
Qualcy is a cloud-based quality management system (eQMS) built for pharmaceutical, biotech, and medical device companies that need to manage regulatory compliance without stitching together multiple point tools. The platform bundles core QMS functions - document control, CAPA, audit management, non-conformance tracking, training management, calibration management, supplier quality management, risk management, and design control - with a dedicated AI-powered Regulatory Intelligence module that monitors regulatory changes, plus a CMMS module for maintenance tracking. Qualcy is sold in three module-based subscription tiers (Basic, Gold, Platinum) priced per admin user per month, and the vendor states all products are 21 CFR Part 11 compliant and hosted on AWS. The company is headquartered in San Diego, California.
Key Features
Document Control — Centralized document management for controlled QMS documentation across the organization.
CAPA Management — Corrective and preventive action tracking software for closing out quality issues.
Audit Management — Tools to plan, run, and track internal and supplier audits.
Regulatory Intelligence (AI) — AI-powered monitoring of regulatory changes affecting pharma, biotech, and medical device compliance.
Training Management — Tracks employee training records and completion tied to QMS requirements.
Risk & Design Control — Risk management and design control modules for product development compliance workflows.
Pros & Cons
Pros
Modular pricing lets teams buy only the QMS modules they need instead of one bloated all-in-one suite.
Combines core eQMS modules (document control, CAPA, audits, NC, training, risk, design control) with an AI-driven regulatory change monitoring module in a single platform.
Vendor states all products are 21 CFR Part 11 compliant and AWS-hosted, aligning with FDA-regulated buyers' needs.
Cons
Pricing page lists per-admin monthly fees plus separate backup/maintenance and basic-user add-ons, which can make total cost less than transparent.
No free trial is advertised, so prospects can't self-serve test the platform before a sales conversation.
Public marketing pages don't disclose founding year, team size, or named third-party integrations, making it harder to independently verify company maturity.