• Document Control
• QAAD Audit Software
• Corrective Action Preventive Action CAPA
• Audit Management Software
• Nonconformance Management
• Electronic Batch Records EBR
• GCP Document Management
• Out of Specification OOS
• Product Data Management PDM System

• Document Management Software
• eProcess Automation
• Integrated Quality Management System
• Training Management & Tracking
• Change Control / Change Management
• Deviations Management
• Complaint Handling & Tracking
• Design Control / Device History Files DHF
• Bill of Materials BOM Software

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 document 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, 21 CFR Part 1270-1271, 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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