Resource Center

The MasterControl™ Resource Center is your personal resource for product information. Select the items you would like to receive, then click on the submit button at the bottom of the page. What resources are you interested in?

Watch Customer Video () Creating a Paperless Process Using MasterControl (3:38)

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Product Data Sheet

The following are data sheets for each product within the MasterControl suite of quality management software solutions. Click on the item for a brief description.

	MasterControl Analytics™
	MasterControl API Toolkit™
	MasterControl ASP™
	MasterControl Audit™
	MasterControl Bill of Materials™
	MasterControl Business Process Library™
	MasterControl CAPA MD™
	MasterControl CAPA PathWise™
	MasterControl CAPA Pharma™
	MasterControl CAPA™
	MasterControl Change Control™
	MasterControl Collaboration™
	MasterControl Copies™
	MasterControl Customer Complaint MD™
	MasterControl Customer Complaint Pharma™
	MasterControl Customer Complaints"
	MasterControl Deviations™
	MasterControl DHF Express™
	MasterControl DHF JumpStart™
	MasterControl Document Connections™
	MasterControl Documents™
	MasterControl Electronic Batch Records™
	MasterControl eMDR™
	MasterControl Enterprise™
	MasterControl Equipment Calibration™
	MasterControl Equipment Maintenance™
	MasterControl Exams™
	MasterControl Forms Quickview™
	MasterControl GCPDocs Express™
	MasterControl GCPDocs JumpStart™
	MasterControl Global Licensing Server™
	MasterControl HR/Finance™
	MasterControl Integrated Quality Suite Overview™
	MasterControl MD™
	MasterControl MS Word Integration™
	MasterControl Nonconformance™
	MasterControl Out-of-Specification™
	MasterControl Outlook E-mail Integration™
	MasterControl PDM Connector for PTC's Pro/Intralink™
	MasterControl PDM Connector for PTC's Windchill™
	MasterControl PDM Connector for SolidWorks PDMWorks™
	MasterControl PDM Connectors™
	MasterControl Portal™
	MasterControl Process™
	MasterControl Projects™
	MasterControl Publishing™
	MasterControl QAAD™
	MasterControl Risk Analysis™
	MasterControl Rules™
	MasterControl SharePoint Connector™
	MasterControl Submissions Gateway™
	MasterControl Submissions Locker™
	MasterControl Supplier Deviation™
	MasterControl Supplier™
	MasterControl Taxonomy Organizers™
	MasterControl TotalMFG™
	MasterControl Training™
	MasterControl Transfer OQ™
	MasterControl/Datafarm GxP2eCTD Connector
	MasterControl/Kofax Interface™
	MasterControl/PleaseReview Collaboration
	Validation Services

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White Paper

MasterControl has a variety of industry white papers to help you with your educational and research needs. Click on the item for a brief description.

	21 CFR Part 11 Industry Overview: Ready for an FDA inspection?
	21 CFR Part 11 Product Positioning
	21 CFR Part 11 Risk of Non-compliance
	21 CFR Part 11 System Validation (Risk management plan)
	5 Ways MasterControl Ensures System Compliance with 21 CFR Part 11
	Automating Document Control Processes
	Automating Electronic Engineering Change
	Automating Training Control Processes
	Calibration Software The Buck Starts at User Requirements
	Change Control - Quality Improvements in FDA and ISO Environments
	Complaint Handling as an Integral Part of FDA and ISO Compliance
	Compliance and Traceability in Regulated Industries Benchmark Report
	Does Your CAPA need a CAPA
	Drug and Device Accountability Act of 2008: How Execs can Avoid Jail Time
	Effective Nonconformance Management Key to FDA and ISO Compliance
	Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?
	Ensuring the Adequacy of the Informed Consent Process in GCP Regulated Environments
	FDA Experts Offer Top Tips to Optimize Your eCTD Submission
	FDA Guidance for Clinical Investigators, Sponsors and IRBs Regarding Adverse Event Reporting in GCP Regulated Environments
	Final FDA Rule on Dietary Supplements - 21 CFR Part 111
	GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems
	Getting Less For Your Money Isn't Always A Bad Thing
	How 21 CFR Part 111 Helps Dietary Supplement Companies
	How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market
	How Software Helps Pharma/Biotech Maximize Value of External Resources
	How to Kick-Start Your CAPA Process
	ISO 14000 Standards
	ISO 9001-2000 Standards
	Managing Change Control to Comply with FDA and EU Regulations
	Noncompliance to FDA Quality Standards: What's the Risk to Executives?
	Pragmatic Approach to Computer Systems Validation
	Quality Audit - A Tool for Continuous Improvement and Compliance
	Reducing the Documentation Burden in FDA Design Control
	Risk Management: Best Practices for Medical Device Profitability
	Sarbanes Oxley Compliance - Challenges and Solutions for Sustained Compliance
	Simplifying CAPA: Seven Steps
	Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments
	Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
	Software Automation in the Blood and Biologics Industry
	Software Automation in the Blood and Biologics Industry
	Software Automation Trends in the Medical Device Industry
	SOP Management as a Compliance Tool in FDA and ISO Environments
	Submissions - Managing Doc Lifecycle
	Technology: What's the Return on Investment
	Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations
	The Importance of Effective Quality Management in Complying with the European Union's GMP Standards
	The Pharmaceutical Industry's Transition to Electronic Processes
	The Top 5 Benefits of Electronic GLP Audit Management
	Top 5 BOM Challenges
	Top Five Ways Automation Can Boost Financial Success

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Q&A

The following are quality management related documents that answer questions relevant to important FDA, ISO, and specific industry issues.

	CAP Accreditation and Document Control
	Compliance ISO 13485 / 21 CFR Part 820 Med Device
	Compliance with FDA's Good Tissue Practices
	FDA Medical Device Investigator Offers Insights on Inspection
	FDA's Quality Systems Approach to Pharmaceutical CGMPs
	Guidelines For The European Medical Device Vigilance System
	ISO 14971 Medical Device Risk Management
	Pharmaceutical CGMP for 21 st Century
	Q&A CDER Official Offers Tips on GMP Inspections
	Risk Management for Pharmaceutical Companies Under FDA's Q9 Guidance

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Tech Paper

The following documents are MasterControl Product Technical Papers, providing detailed feature information specific to each product. Click on the item for a brief description.

	MasterControl Analytics™
	MasterControl Audit™
	MasterControl CAPA"
	MasterControl Change Control™
	MasterControl Customer Complaints™
	MasterControl Document Connections™
	MasterControl Documents™
	MasterControl Enterprise™
	MasterControl Nonconformance™
	MasterControl Process™
	MasterControl Rules™
	MasterControl SOX™
	MasterControl Training™

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Case Study

The following MasterControl customers are examples of how MasterControl has helps organizations from a variety of industries overcome stringent quality and regulatory challenges. Click on the item for a brief description.

	Aplicare
	ARUP Laboratories
	Asymtek
	Bio-Imaging
	Hu-Friedy
	Iowa Blood
	Mallinckrodt Baker
	Namsa
	Sorenson Medical
	Stay InFront
	Syncardia Systems
	Teva Pharmaceuticals
	Weider Nutrition

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Webinar

MasterControl provides complimentary Web seminars on a issues relating to quality control and related industries. Select the webinars below that you would like to view, then click on the submit button at the bottom of the page.

	AberdeenGroup - The Cost of Quality: a Study on Life Sciences
	Automating and Integrating Employee Training Processes to Ensure Compliance
	Automating Quality Audits for Regulatory Compliance
	Effective Bill of Materials (BOM) Management
	GAMP 5 - A Risk-based Approach to Compliant GxP Computerized Systems
	Improving Supplier Management
	Integration of Lorenz docuBridge and MasterControl for Electronic Submissions
	MasterControl - Quality Audit Challenges and Solutions
	Methods to Achieve Compliance with Sarbanes-Oxley
	Overview: Quality System Regulation (QSR)
	Problem Solving in the Lean Supply Chain
	Program for simplifying and authoring SOPs
	Project Management Challenges in Medical Device New Product Development
	Risk Management: FDA Regulated Industries
	Simplifying Batch Record documentation in preparation for MES/EBR
	Software as a Service (SaaS) - Is it Right for Your Company?
	The Importance of Effective CAPA and Root Cause Analysis Processes
	Using Document Templates to Accelerate Time to Submissions with MasterControl and Sage

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Interactive and Live Demonstration

We provide interactive and customer online demonstrations of the MasterControl suite of quality management solutions. Download one now.

	MasterControl Quality Suite Demonstration
	MasterControl Resource Presentation
	MasterControl Executive Presentation

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Promotional

	A system that pays you back
	Accelerating Time to Market

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Analyst Report

	Aberdeen: The Cost of Quality: a Study on Life Sciences
	Achieving Quality Across the Global Manufacturing Network

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Please check back often as new seminars will be added. If you would like to be notified of new webinars, click here to register for our web seminar e-mail list.

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