--- description: Review of MasterControl Quality Excellence Software: system overview, features, price and cost information. Get free demos and compare to similar programs on Software Advice Ireland. image: https://gdm-localsites-assets-gfprod.imgix.net/images/software_advice/og_logo-55146305bbe7b450bea05c18e9be9c9a.png title: MasterControl Quality Excellence | Reviews, Pricing & Demos - SoftwareAdvice IE --- Breadcrumb: [Home](/) > [Quality Management Software](/directory/420/quality-management-software/software) > [MasterControl Quality Excellence](/software/142000/mastercontrol) # MasterControl Quality Excellence Canonical: https://www.softwareadvice.ie/software/142000/mastercontrol Page: 1 / 23\ Next: [Next page](https://www.softwareadvice.ie/software/142000/mastercontrol?page=2) > Quality Management—Simplified with Life Sciences-Specialized AI MasterControl Quality Excellence (Qx) is the \#1 Quality Management System (QMS) in life sciences. Built on an AI-driven platform, it enables life-sciences companies to enable flexible quality event management, simplified document management, and automated training management—that all work seamlessly together to close the loop on quality. Qx is, trusted by more than 1,300 pharmaceutical, biotech, and medical device companies worldwide — including the FDA itself. Qx is an electronic quality management system (eQMS) purpose-built for regulated manufacturers that must comply with FDA 21 CFR Part 11, 21 CFR Part 210-211, QMSR, EU GMP Annex 11 and Annex 22, ISO 13485, GxP, and other global quality requirements, including EMA, MHRA, Health Canada, TGA, and PMDA jurisdictions. Qx connects document control, change control, training, quality event management (including CAPA), audits, and risk in a single closed-loop system, so information moves automatically between processes instead of through manual handoffs. When a document changes, training assignments trigger automatically for affected employees. When a quality event opens, related CAPAs can launch with context already populated, and audit findings link directly to corrective actions. Every action generates an immutable, audit-ready record — so instead of assembling evidence before an inspection, quality teams retrieve it in seconds and demonstrate compliance with confidence. Qx's patented Validation Excellence Tool (VxT) and Validation on Demand (VoD) reduce computer system validation from a months-long project to a process measured in minutes, aligned with FDA Computer Software Assurance (CSA). Compliant, specialized AI tools — including a Document Summarizer, SOP Analyzer, Exam Generator, Regulatory Chat, and Quality Event Summarizer — accelerate everyday quality work while keeping qualified humans in control of every decision. Used by pharmaceutical, biotech, and medical device manufacturers across North America, Europe, Asia-Pacific, and other global regulated markets, Qx scales from single-site startups to global, multi-site enterprises on one validated platform. Natively connected to MasterControl Manufacturing Excellence (Mx) and Asset Excellence (Ax), Qx extends quality directly to the shop floor and into asset management, creating one source of truth across the entire regulated operation, from organizational policy to the entry made by a technician on the floor. > > Verdict: Rated **4.5/5** by 540 users. Top-rated for **Likelihood to recommend**. ----- ## Quick Stats & Ratings | Metric | Rating | Detail | | **Overall** | **4.5/5** | 540 Reviews | | Ease of Use | 4.1/5 | Based on overall reviews | | Customer Support | 4.5/5 | Based on overall reviews | | Value for Money | 4.2/5 | Based on overall reviews | | Features | 4.2/5 | Based on overall reviews | | Recommendation percentage | 80% | (8/10 Likelihood to recommend) | ## About the vendor - **Company**: MasterControl - **Location**: Salt Lake City, US - **Founded**: 1994 ## Commercial Context - **Starting Price**: US$25,000.00 - **Pricing model**: Other - **Pricing Details**: Flexible packaging from Quality Excellence Starter — pre-configured, pre-validated, and operational in 90 days for emerging life sciences companies — through Quality Excellence Complete for organizations needing full closed-loop quality management. Contact MasterControl for a package and pricing tailored to your organization's size and regulatory requirements. - **Target Audience**: 2–10, 11–50, 51–200, 201–500, 501–1,000, 1,001–5,000, 5,001–10,000, 10,000+ - **Deployment & Platforms**: Cloud, SaaS, Web-based, Android (Mobile), iPhone (Mobile), iPad (Mobile) - **Supported Languages**: English, French, Japanese - **Available Countries**: Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Iceland, Ireland, Isle of Man, Italy, Japan, Jersey, Malaysia, Netherlands, New Zealand, Norway, Philippines and 12 more ## Features - Access Controls/Permissions - Activity Dashboard - Activity Tracking - Alerts/Escalation - Alerts/Notifications - Approval Process Control - Archiving & Retention - Audit Management - Audit Planning - Audit Trail - Automated Scheduling - Bills of Material - Business Process Control - Change Management - Collaboration Tools - Commenting/Notes - Communications Management - Complaint Management - Compliance Management - Compliance Tracking ## Integrations (16 total) - ADP Workforce Now - Arena - ComplianceWire - Microsoft 365 - Microsoft SQL Server - NetSuite - PowerBI Portal - SAP BTP - Sage - Salesforce Platform - ServiceNow - SharePoint Integration - Snowflake - Tableau - UKG Pro ... and 1 more integrations ## Support Options - Email/Help Desk - FAQs/Forum - Knowledge Base - Phone Support - Chat ## Category - [Quality Management Software](https://www.softwareadvice.ie/directory/420/quality-management-software/software) ## Related Categories - [Medical Lab Software](https://www.softwareadvice.ie/directory/4538/medical-lab/software) - [Audit Software](https://www.softwareadvice.ie/directory/4188/audit/software) - [Pharmacy Software](https://www.softwareadvice.ie/directory/88/pharmacy/software) - [Product Lifecycle Management Software](https://www.softwareadvice.ie/directory/444/product-lifecycle-management/software) - [Compliance Software](https://www.softwareadvice.ie/directory/4363/compliance/software) ## Alternatives 1. 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However, this complexity has a purpose to keep things simple for the end user. > > Overall, the experience with Qx has been great. The system does what it needs to with few issues. For the most part, MC is responsive and fixes these issues. However, reporting can be challenging with data "living" in multiple reports, requiring outside services to combine them into something usable (e.g., 6 fields you need are on one report, and 3 are on another) and the "new" report solution still has many data errors and latency issues. ----- ### "Robust eQMS platform for regulated environments" — 4.0/5 > **Simone** | *20 May 2026* | Pharmaceuticals | Recommendation rating: 7.0/10 > > **Pros**: MasterControl Quality Excellence is a solid and comprehensive eQMS platform, particularly suitable for highly regulated industries such as pharmaceuticals and medical devices. One of its main strengths is the ability to centralize quality processes including CAPA, deviations, change controls, training management, document control and audit management within a single integrated environment. The workflow configuration is flexible and supports compliance with GxP requirements, electronic signatures and audit trails. It also improves traceability, collaboration between departments and overall inspection readiness. The reporting and dashboard capabilities are useful for trending and KPI monitoring. > > **Cons**: The platform can sometimes feel complex and not fully intuitive for end users, especially during the initial learning phase. Certain configurations and workflow customizations require significant administrative support and can become time-consuming. Some modules could benefit from a more modern and user-friendly interface, and system performance may occasionally slow down when handling large processes or extensive datasets. Reporting customization could also be more flexible without requiring advanced configuration knowledge. > > Overall, my experience with MasterControl Quality Excellence has been positive. It is a reliable and mature solution for managing quality systems in regulated environments and it supports digital transformation initiatives effectively. While there are areas that could be improved in terms of usability and flexibility, the platform provides strong compliance support and helps standardize quality processes across different functions and sites. It is particularly valuable for organizations looking to move from paper-based systems to a more integrated electronic quality management approach. ----- ### "eQMS upon your needs" — 4.0/5 > **Verified Reviewer** | *20 May 2026* | Biotechnology | Recommendation rating: 10.0/10 > > **Pros**: Flexible system, can be configured upon your needs. Easy to improve and adjust if necessary. Great tool for digitalization. > > **Cons**: Some new products promise good and helpful functionality but lack at some points. Delivered to fast. > > I like the system because of its flexibility and you can always find a way to implement required features. ----- ### "Excellent traceability, training and Support for multiple departments" — 4.0/5 > **Karina** | *30 July 2026* | Pharmaceuticals | Recommendation rating: 8.0/10 > > **Pros**: The Documents and training module are so easy to use. I love how multiple collaborators can work on something and you have traceability of who added what. Also, training tasks are easy to assign and automate so that you never have to fall behind. The supplier module has also been great for us so that we are able to keep track of our approved suppliers and which products they supply to us. We have even be able to indicate which markets the products are approved for which helps our demand/planning and purchasing teams. > > **Cons**: The Audit module needs to be updated. When we were using it, there were many defects and work arounds that we had to use. This caused a lot of inefficiencies in our process as we had to restart multiple times. > > Overall, we would recommend using MasterControl. They have so many tools to support you in whatever stage of the process you are in. Customer support is outstanding and we always have a quick response to the issues we are dealing with. We feel well supported and taken care of. ----- ### "Reliable Quality Management, but Implementation Can Be Challenging" — 4.0/5 > **Marco** | *16 February 2026* | Biotechnology | Recommendation rating: 8.0/10 > > **Pros**: What I liked most about MasterControl Quality Excellence is its strong focus on compliance and its ability to streamline collaboration across teams. The system provides clear, structured workflows that support efficient task management and full traceability. I especially appreciate the ready‑to‑use digital forms, which are already designed around industry‑standard processes and allow teams to start working immediately without lengthy configuration. > > **Cons**: The main limitations I experienced with MasterControl Quality Excellence are related to usability and system stability. The interface can feel unintuitive for new users, requiring more training than expected to become fully comfortable. Additionally, some modules still show occasional bugs or inconsistent behaviors that slow down daily operations and require follow‑up with support. Implementation can also be time‑consuming due to the complexity of the platform and the level of coordination needed across teams. > > MasterControl Qx is a solid and compliance‑focused quality management system that delivers strong collaboration and form management features. However, the platform could benefit from improved usability, quicker bug resolution, and more competitive pricing. It’s a great fit for organizations with strict regulatory requirements and structured internal processes. ----- Page: 1 / 23\ Next: [Next page](https://www.softwareadvice.ie/software/142000/mastercontrol?page=2) ## Links - [View on SoftwareAdvice](https://www.softwareadvice.ie/software/142000/mastercontrol) ## This page is available in the following languages | Locale | URL | | de | | | en | | | en-AU | | | en-GB | | | en-IE | | | en-NZ | | | fr | | ----- ## Structured Data