MasterControl Inc.

Company Overview
MasterControl Inc. has been providing innovative electronic quality management systems since 1993. MasterControl offers a configurable, easy-to-use, integrated system to help companies effectively manage document control, change control, training control, audits, corrective/preventive action (CAPA) issues, customer complaints, Sarbanes-Oxley compliance and other quality and compliance processes under a single Web-based platform. It also offers comprehensive technical and customer support, including product training and validation services. MasterControl has distinguished itself as an organization that offers not just software, but solutions to critical problems faced by regulated companies. The MasterControl integrated quality management software suite combines robust software, expert services honed by experience, and exceptional customer care. MasterControl services include implementation, training, validation services and technical support for FDA-regulated companies.

Quick Facts
MasterControl Inc.
6322 South 3000 East, Suite 110
Salt Lake City, Utah 84121

Web:	www.mastercontrol.com
Email:	info@mastercontrol.com

Phone:	1 (801) 942-4000, 1 (800) 825-9117
Fax:	1 (801) 942-7088

Featured Solutions

• Tracking and controlling employee training records and requirements in FDA ... by MasterControl Inc.
  This white paper from MasterControl identifies the basis for employee training requirements and examines the challenges to meet them, the shortcomings that lead to general system failures, and a new approach for meeting and going beyond tracking requirements.
  
  
• Adoption of MasterControl key to efficient, FDA-compliant document management... by MasterControl Inc.
  In this case study, MasterControl helps Aplicare create and validate an electronic document control and change management system for U.S. Food and Drug Administration (FDA) computer systems validation compliance.
  
  
• Efficiency keeps ARUP industry leader by MasterControl Inc.
  In this case study, MasterControl installs systems for ARUP Laboratories that help the fast-growing lab-testing company achieve compliance and improve efficiency, process management and turnaround times.
  
  
• Improving efficiency at Blood Center of Iowa by MasterControl Inc.
  In this case study, MasterControl installed validation systems and trained employees at the Blood Center of Iowa, moving the company from an inefficient, redundant paper-based system and improve control of documents.
  
  
• MasterControl facilitates accurate, efficient FDA compliance at Teva USA by MasterControl Inc.
  In this case study, MasterControl cut the time it took to modify approve documents that kept Teva Pharmaceuticals USA in total compliance with U.S. Food and Drug Administration (FDA) regulations.
  
  
• Automating document change control by MasterControl Inc.
  This white paper by MasterControl Inc. describes the quality system lifecycle and the capabilities necessary to automate change control processes to increase efficiency and ensure Food and Drug Administration compliance.
  
  
• Product positioning by MasterControl Inc.
  This white paper by MasterControl Inc. describes 21 CFR Part 11 regulations regarding electronic signatures and document encryption.
  
  
• Are you ready for an FDA inspection? by MasterControl Inc.
  This white paper by MasterControl Inc. describes how it went about becoming compliant with Food and Drug Administration standards, the difficulties involved and how companies can go through the same process.
  
  
• Automating corrective and preventive actions in FDA environments by MasterControl Inc.
  This white paper by MasterControl Inc. describes how most companies create a corrective and preventive action (CAPA) program and the elements of successful electronic CAPA systems.
  
  
• Five ways MasterControl helps ensure system compliance with 21 CFR Part 11 by MasterControl Inc.
  This white paper by MasterControl Inc. discusses five ways to ensure system compliance with 21 CFR Part 11 using System SOP.
  
  
• How Effective Document Management Could Help Accelerate Time to Market by MasterControl Inc.
  This paper explains why document management is critical throughout the drug development process; examines common challenges pertaining to document control during each phase of the process (pre-clinical, clinical, commercialization, launch and post-market); and offers ways to maximize development time and avoid delays due to poor document management.
  
  
• Complaint handling as an integral part of FDA and ISO compliance by MasterControl Inc.
  This white paper by MasterControl Inc. explains regulations and standards required to handle customer complaints in a compliant manner, and how to address challenges including lack of standard procedure, inadequate documentation, customer access and management strategy through MasterControl's own solution.
  
  
• Q and A: CDER official offers tips on GMP inspections by MasterControl Inc.
  In this white paper, MasterControl's Q&A session with a federal regulatory official reveals the top three areas that FDA investigators scrutinize during GMP inspections.
  
  
• SOP management as a compliance tool in FDA and ISO environments by MasterControl Inc.
  This white paper by MasterControl discusses why Standard Operating Procedures (SOPs) are more than just a tool of operation, and how an effective SOP management system can support both sustainable compliance and long-term success in the market.
  
  
• Quality Audit: A tool for continuous improvement and compliance by MasterControl Inc.
  In the FDA and ISO environments, the audit process is closely associated with quality and directly related to regulatory compliance. This MasterControl white paper discusses the challenges facing companies that rely on a paper-based or a partially electronic system, and the benefits of implementing an electronic auditing solution.<BR>
  
  
• The Pharmaceutical Industry’s Transition to Electronic Processes by MasterControl Inc.
  This paper by MasterControl takes a frank look at some valid reasons for hesitation to electronic solutions, and provides a much-needed proposal for getting started.
  
  

• Managing corrective-preventive actions in regulated industries by MasterControl Inc.
  In this application note, MasterControl Inc. describes the need to establish an effective corrective action/preventive action (CAPA) program and how MasterControl CAPA helps companies to manage the corrective action processes that are critical in maintaining compliance.
  
  
• Modernizing quality control systems by MasterControl Inc.
  In this application note, MasterControl Inc. describes the quality systems model and how its software automates, tracks and manages document- and forms-based quality processes and employee training.
  
  
• Importance of training control in FDA environments by MasterControl Inc.
  This application note by MasterControl talks about common stumbling blocks in training management, FDA regulations and ISO standards that require training control, major challenges in implementing training, and how MasterControl's solution can help life sciences professionals address those challenges.
  
  
• Managing forms-based quality processes by MasterControl Inc.
  In this application note, MasterControl Inc. describes its MasterControl Forms, which were developed as part of an integrated solution to help companies manage forms-based processes that are critical in ensuring compliance, efficiency and overall competitiveness.