Solutions

What We Offer

01Quality 02Manufacturing 03Clinical 04Regulatory 05Supplier 06Product Development 07Postmarket

Quality Solution Overview Document Control Change Control Training Management CAPA Software Deviations Management Nonconformance Out of Specification Audit Management Quality Management Risk Management Data and Analytics

Manufacturing Solution Overview Batch Records Device History Records Equipment Calibration Recipe Management System Variant Management Data and Analytics

Clinical Solution Overview Clinical Management Trial Master File Trial Software TMF Checklist

Regulatory Solution Overview Regulatory Information Management (RIM) Submissions for 510(K) and PMA Submissions for eCTD Submissions Management 510K Guidance CTD File

Supplier Solution Overview Supplier Management Bill of Materials Supplier Management Audits Vendor Management Supplier Scorecard Supplier Corrective Action Request Supplier Deviation

Development Solution Overview Design Control Change Control Software Change Management Software Change Order Change Management Tool

Postmarket Solution Overview Customer Complaints Medical Device Reporting (eMDR) Complaint Tracking System Complaint Example Device Reporting Software

Industries

Integrated software solutions for a variety of industries.

Platform

Explore the MasterControl Product Life Cycle Management Platform

Pricing

Explore our pricing plans and request an estimate from our team.

Services

Unrivaled Deployment Experience. Faster Solution Delivery.

Learning Center

Explore Our Knowledge Base

01Resources 02FDA 03ISO 04Global 05Platform Integrations 06Templates and Guidelines

Resource Center Quality ROI Calculator Manufacturing ROI Calculator Blog - GxP Lifeline Customer Awards

21 CFR Part 11 21 CFR Part 111 21 CFR Part 1270—1271 21 CFR Part 210—211 21 CFR Part 606 21 CFR Part 820

ISO 9000 ISO 9001 ISO 13485 ISO 14000 ISO 14971 ISO 15189 ISO 17025

TS 16949 CLIA Canadian Standards EU Annex 11 EU Medical Device Regulation Therapeutic Goods Administration (TGA) Regulations

ERP Software System MRP Software System MES System Manufacturing Resource Planning Production Operations Management LIMS System

SOP Template Change Control Template Design Control Template GMP Guidelines SOP Guidelines ICH Guidelines ECTD Guidelines CDER Guidelines

GxP-Lifeline Blog

Read our newest articles from our industry experts.

Resource Center

Search our collection of authoritative publications.

Quality Awards

The Masters of Excellence

About Us

Who We Are

01Our Company 02Events 03Become a Partner

About MasterControl Our Core Values Executive Team MasterControl In The News Careers Contact Us

Upcoming Events Masters Summit North America Masters Conference Europe Industry Events Webinars

MasterControl Associations Partner Program Referral Partners Sales Partners Service Partners Technology and Strategic Partners

Careers

We are growing fast and look for people to join the team.

Become A Partner

Learn about the variety of partnerships available in our network.

Events

Explore the upcoming events.

Masters Summit

Learn about the upcoming industry event.

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Meet Our Executive Team

Our executives bring a wealth of knowledge to the cause!

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info@mastercontrol.com

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Solutions

Quality
Manufacturing
Clinical
Regulatory
Supplier
Product Development
PostMarket

Learning Center

Resource Center
Blog - GxP Lifeline

About Us

About MasterControl
Upcoming Events
Partner Program
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6350 South 3000 East
Salt Lake City, Utah 84121 View map

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