Regulations & Standards Overview

The Regulations & Standards Overview of compliance with federal regulations and adherence to international quality standards is part of doing business for most industries.

Regulations and standards overviews are provided 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.

Watch Videos View FDA 3-Minute Demo (3:00) Using MasterControl for FDA Compliance (3:53) Using MasterControl for ISO Certification (2:17)

MasterControl Regulations & Standards Overview

Since 1993, hundreds of companies in a wide range of regulated industries have relied on the MasterControl's 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 Standards
• ISO 14000
• ISO 13485
• TS 16949
• CLIA Regulations
• Canadian Quality Standards
• Europen Union Standards

Compliant - Sustained System for Regulations & Standards

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

Connected Regulations & Standards system for an 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.