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"MasterControl met all our document control and quality needs including the necessary elements to comply with 21 CFR Part 11 for electronic records and signatures." -

ARUP Laboratories


"MasterControl really stood apart from the other quality management software companies in the area of cost compared to value." -

Teva Pharmaceuticals


"The auditors gave very favorable comments about our MasterControl document control system. They noticed that everything was easily traceable, documents were readily available, and electronic signatures were all there." -

Mallinckrodt Baker

"We're actually changing more documents and doing more work now.” -

NAMSA

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MasterControl is an integrated QUALITY and COMPLIANCE management software system for FDA, EMEA / EU-regulated companies.

Integrated software systems include Corrective Action Preventive Action CAPA, Document Control, Electronic Batch Records, Deviations, Training Management / Tracking , Change Control, Audits, Nonconformance Management, Complaints Handling, eProcess Automation, Electronic Batch Records EBR, Device History Records DHR, Out of Specification OOS, Statistical Process Control SPC, and Sarbanes-Oxley (SOX).

MasterControl provides easy-to-use, integrated quality and compliance management solutions that help companies automate EMEA / EU, FDA, and ISO-based content management processes. More than just a software company, MasterControl also offers implementation, training, and validation services to maximize our customers' efficiencies and savings.

Learn why hundreds of companies have chosen MasterControl to automate their CAPA, document control, change control, training, audit management, and other quality management and regulatory processes.


Quality Management System Software for Life Science
Pharmaceutical, medical device, CROs, laboratories, and other life science manufacturers walk a fine line trying to balance the implementation of quality and regulatory compliance processes without breaking the bank. By using MasterControl to automate document control systems, corrective action and preventive action (CAPA) processes, training control and other quality management initiatives, these manufacturers are finding the results they've been looking for.

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Why Corrective and Preventive Action CAPA Systems?
Corrective Action and Preventive Action / CAPA are required quality measures that must be maintained as outlined in the 21 CFR 820.100 and 21 CFR 211.180 regulations and in ISO 8402. The purpose of CAPA is to make sure the root cause of any problem is addressed so that current or future problems will be alleviated. As witnessed from FDA Form 483 observations and warning letters published on the FDA's Website, corrective action and preventive action problems are dealt with strictly during FDA systems-based inspections. According to the FDA, 30 percent to 50 percent of all 483s are directly due to CAPA nonconformances. These percentages have varied when using different inspection methods by FDA inspectors such as the Quality Systems Inspection Technique / QSIT.

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Why Document Control Systems for FDA and ISO Quality?
Controlling documentation is critical to compliance for FDA and ISO-regulated manufacturers. To ensure compliance, companies must control documents so that product is being built off the most current specs. They must also automate manual systems for document control, approval, signoff and change control management processes to improve efficiency. MasterControl provides more than just a docment control system through its integrated quality management software suite that consists of full-featured, integrated modules for change control, CAPA, training, etc. The suite helps ensure compliance with ISO 9000 / ISO 14000 quality standards and FDA regulatory requirements like CGxP, 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 820, 21 CFR Part 606, and Sarbanes-Oxley.

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White Papers
MasterControl has a variety of industry white papers to help you with your educational and research needs. Click on each white paper for a summary.

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Why Sarbanes-Oxley SOX Compliance?
One of the great challenges for Sarbanes-Oxley (SOX) compliance is maintaining the initial compliance. Not only does it mean continuous monitoring, but it also means constant re-assessment of risks and controls. This document change control aspect for both Sections 302 and 404 of SOX is what MasterControl has been supplying to its users for over 10 years through its proven document control system and quality management software.

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Why is MasterControl the Right Solution for Your Industry?

Compliant Document Control Software Compliant.
Sustained Regulatory
Compliance

Connected Document Control System Connected.
Integrated Quality
Management

A Complete Document Management System used Enterprise-wide Complete.
Enterprise-wide
Product Application

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Our Solutions
The MasterControl Integrated Quality Management Software Suite has proven to reduce the costs of managing quality content and business processes within ISO and FDA-regulated organizations.

Over 400 companies use MasterControl to automate their quality, and regulatory processes.
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