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    MasterControl

    Quality & compliance for life sciences

    4.4 · 1031 reviews across platforms
    Quality Management149 QHSE teams reviewed this page in the last 30 days
    1000+ · 201-1000 Pharmaceutical +4

    No signup · Direct vendor link · 100% free

    At a Glance

    Best for

    Pharmaceutical · 1000+

    Standout

    Industry-leading in life sciences

    Watch out for

    Premium pricing

    Pricing $$$

    Enterprise / Custom

    Overview

    MasterControl provides quality management, document control, and regulatory compliance solutions for highly regulated industries.

    Verified Listing

    Reviewed by The QHSE Standard · Jul 2026

    Fits 1000+ · 201-1000

    Company size coverage

    5+ Industries

    MasterControl use-cases mapped

    In-Depth Analysis

    MasterControl provides quality management system software with robust document control, training management, CAPA, and audit capabilities designed for FDA-regulated and life sciences industries. The platform's document control module supports 21 CFR Part 11 compliant electronic signatures, version-controlled workflows, and automated periodic review reminders. The training management module automatically links document changes to training requirements, ensuring affected personnel are assigned retraining. MasterControl's Manufacturing Excellence module extends beyond traditional QMS into production batch record management with electronic execution.

    Key Features

    Document Control
    CAPA Management
    Training Management
    Change Control
    Validation Management
    Audit Management
    Supplier Qualification
    Risk Management
    Electronic Signatures
    Batch Records

    Pros & Cons

    Industry-leading in life sciences
    Strong FDA compliance
    Comprehensive QMS
    Excellent training module
    Premium pricing
    Complex implementation
    Steep learning curve
    Life sciences focused

    Pricing

    Starting at

    Custom quote

    Model: Subscription

    Tier $$$

    Enterprise pricing. Contact for quote.

    Get a custom quote

    Pricing varies by modules, users, and contract length. Always confirm with the vendor.

    How MasterControl Compares

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    Frequently Asked Questions

    What industries does MasterControl serve?
    MasterControl is specifically designed for life sciences, including the pharmaceutical, medical device, and biotechnology sectors. It also provides quality and compliance solutions for the food and beverage and general manufacturing industries.
    Does MasterControl support ISO and FDA compliance?
    Yes, the software is built to help organizations adhere to strict regulatory standards such as FDA 21 CFR Part 11 and GxP. It also supports compliance with international quality standards including ISO 13485 and ISO 9001.
    What are the core features of the MasterControl platform?
    The platform offers a comprehensive suite of tools including Document Control, CAPA Management, Training Management, and Audit Management. Additionally, it supports advanced needs like Electronic Batch Records, Supplier Qualification, and Risk Management.
    How is the software priced and what company sizes is it for?
    MasterControl is offered through a subscription-based pricing model. It is primarily designed for mid-market and enterprise-level organizations, typically serving companies with 201 to over 1,000 employees.
    Does the system handle electronic signatures and validation?
    Yes, MasterControl includes built-in functionality for Electronic Signatures to ensure secure approvals and record-keeping. It also features dedicated Validation Management to help life science companies maintain their validated state more efficiently.

    AI-generated FAQ — verify details with the vendor.

    Interested in MasterControl?

    Get a personalized demo and see how it fits your organization.

    Book a Demo

    Why The QHSE Standard picked it

    • Industry-leading in life sciences
    • Strong FDA compliance
    • Comprehensive QMS
    Visit Website View Alternatives

    Pricing

    Model: Subscription

    Starting at:

    Enterprise pricing. Contact for quote.

    Supported Processes

    document-managementcapa-managementemployee-trainingiso-managementcomplaint-managementaudits-inspections

    Industries

    PharmaceuticalMedical DevicesBiotechnologyFood & Beverage+1 more

    Company Size

    1000+, 201-1000 employees

    Certifications

    FDA 21 CFR Part 11ISO 13485ISO 9001GxP