Regulations & Standards Overview

Compliance with federal regulations and adherence to international quality standards is part of doing business for most industries.

Regulations and standards exist to protect consumers and the public in general. They are a major driving force for companies to manufacture and sell products (or provide services) that are safe, reliable, and effective.

Download Free Documents
	White Paper: 21 CFR Part 11 Risk of Non-compliance
	White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
	White Paper: How to Successfully Manage Your Suppliers and Ensure Product Safety and Compliance
	White Paper: Noncompliance to FDA Quality Standards: What's the Risk to Executives?

Watch Videos MasterControl's Documents Module (2:02) Creating a Paperless Process Using MasterControl (3:38) Using MasterControl for FDA Compliance (3:53) Using MasterControl for ISO Certification (2:17)

MasterControl Solution

Since 1993, hundreds of companies in a wide range of regulated industries have relied on the MasterControl™ integrated quality management suite to attain and sustain compliance with regulations and standards such as:

• 21 CFR Part 11
• 21 CFR Parts 210 - 211
• 21 CFR Part 820
• 21 CFR Part 606
• ISO 9000
• ISO 14000
• ISO 13485
• TS 16949
• SOX
• CLIA
• Canadian Quality Standards

Compliant - Sustained Compliance

MasterControl is compliant, helping you meet FDA regulations and ISO quality standards year after year.

Connected - Integrated Quality Management Suite

MasterControl is connected, giving you the ability to monitor the entire quality system and continuously improve it.

Complete Enterprise-wide Product Application

MasterControl is complete, meeting every department's needs to ensure that quality initiatives are enforced across the enterprise.