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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 Spark QMS for Small Business

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

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 510K Guidance CTD File

Supplier Solution Overview Supplier Management Bill of Materials Supplier Management Audits Vendor Management SCAR 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

Platform

Explore the MasterControl Product Life Cycle Management Platform

Events

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Become A Partner

Learn about the variety of partnerships available in our network.

Careers

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

Resources

Resources

COMPLIANCE CENTER

01FDA 21 CFR 02ISO 03Global Regulations 04Platform Integrations 05Templates and Guidelines

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

Platform

Explore the MasterControl Product Life Cycle Management Platform

Events

Explore the upcoming events .

Become A Partner

Learn about the variety of partnerships available in our network.

Careers

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

About Us

About Us

WHAT WE OFFER

01Our Company 02Events 03Become a Partner

Why MasterControl Executive Team MasterControl In The News

Upcoming Events Masters Summit North America Masters Conference Europe Masters Forum Asia Let's do Lunch Customer Awards

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

Platform

Explore the MasterControl Product Life Cycle Management Platform

Events

Explore the upcoming events .

Become A Partner

Learn about the variety of partnerships available in our network.

Careers

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

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