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 Videos How MasterControl Makes Your Job Easier (3:50) Creating a Paperless Process Using MasterControl (3:38)

---

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.

	Design Control Templates
	MasterControl Accident/Injury™
	MasterControl Advanced Packet Types™
	MasterControl All Access Product Summary
	MasterControl All Access™
	MasterControl Analytics™
	MasterControl API Toolkit™
	MasterControl ASP™
	MasterControl Audit Essentials™
	MasterControl Audit™
	MasterControl Bill of Materials™ (BOM)
	MasterControl Blood and Biologics Express Suite™
	MasterControl Business Process Library™
	MasterControl CAPA MD™
	MasterControl CAPA Pharma™
	MasterControl CAPA™
	MasterControl Change Control™
	MasterControl Classes™
	MasterControl Clinical Lab Jumpstart™
	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 Collections™
	MasterControl Document Connections™
	MasterControl Documents™
	MasterControl Educational Services
	MasterControl Electronic Batch Records™ (EBR)
	MasterControl eMDR™
	MasterControl ENG™ (for ISO)
	MasterControl ENG™ (for medical device)
	MasterControl Enterprise Business Units™
	MasterControl Enterprise Integrations™
	MasterControl Enterprise Remote File Server™
	MasterControl Equipment Calibration™
	MasterControl Equipment Maintenance™
	MasterControl Exams™
	MasterControl Forms Quickview™
	MasterControl GCPDocs Express™
	MasterControl GCPDocs JumpStart™
	MasterControl Global Licensing Server™
	MasterControl Guest Connect™
	MasterControl HR Finance™
	MasterControl Incident Reporting™
	MasterControl MD™
	MasterControl MS Word Integration
	MasterControl Multi-Language Translations
	MasterControl Nonconformance™
	MasterControl Not-for-Profit Pricing
	MasterControl Out-of-Specification™
	MasterControl Outlook E-mail Integration™
	MasterControl PDF Publishing™
	MasterControl PDM Connector for PTC's Pro/Intralink™
	MasterControl PDM Connector for PTC's Windchill™
	MasterControl PDM Connector for SolidWorks PDMWorks™
	MasterControl PDM Connector for SolidWorks® Enterprise
	MasterControl PDM Connectors™
	MasterControl Pharma R&D™
	MasterControl Portal™
	MasterControl Process™
	MasterControl Project Management Services
	MasterControl Projects™
	MasterControl PTC® PDM Connectors
	MasterControl QAAD 8.0 - What's New
	MasterControl QAAD API™
	MasterControl QAAD Hosted Services
	MasterControl QAAD Version 8.3 Integration
	MasterControl QAAD Version 8.3: What's New
	MasterControl QAAD™
	MasterControl QE Audit
	MasterControl QEM CAPA Workshop
	MasterControl QEM Core Solution Set
	MasterControl QEM Core Solution Set for ISO Guided Companies
	MasterControl QEM Premium Solution Set™
	MasterControl QEM Premium Solution Set™ for ISO Guided Companies
	MasterControl QEM Root Cause Investigations Workshop
	MasterControl QMS and QEM Systems
	MasterControl QMS and QEM Systems for ISO Guided Companies
	MasterControl QMS and QEM Systems Package Selector
	MasterControl QMS and QEM Systems Package Selector for ISO Guided Companies
	MasterControl Recorded Online Training™
	MasterControl Reference Model™ - EDM Jumpstart
	MasterControl Risk Analysis™
	MasterControl Risk™
	MasterControl Rules™
	MasterControl SharePoint Connector™
	MasterControl SolidWorks® PDM Connectors
	MasterControl Submissions Gateway™
	MasterControl Submissions Locker™
	MasterControl Submissions Ready™
	MasterControl Suite Overview
	MasterControl Supplier Corrective Action (SCAR)™
	MasterControl Supplier Deviation™
	MasterControl Supplier Scorecard™
	MasterControl Supplier™
	MasterControl TotalMFG™
	MasterControl TotalPharma™
	MasterControl Training™
	MasterControl Transfer OQ™
	MasterControl Variance™
	MasterControl/Datafarm GxP2eCTD Connector
	MasterControl/Kofax Interface™
	MasterControl/PleaseReview Collaboration
	MasterControl™ Software Solutions Summary
	MasterControl™ Solutions Overview
	QMS MasterControl CAPA Workshop for ISO Guided Companies
	QMS MasterControl Root Cause Investigations Workshop for ISO Guided Companies
	Trial Site Workshop
	Validation Services

     Return to Top of Page

---

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 MasterControl QAAD Product Positioning
	21 CFR Part 11 Risk of Non-compliance
	21 CFR Part 11 System Validation (Risk Management Plan)
	21 CFR Part 11: MasterControl Product Positioning
	5 Ways MasterControl Ensures System Compliance with 21 CFR Part 11
	Automating Document Control Processes
	Automating Electronic Engineering Change
	Automating Quality Compliance and Business Process within the Food and Beverage Industry
	Automating Training Control Processes
	Calibration Software: The Buck Starts at User Requirements
	cGMP and ISO 13485 Integrated Quality Management System
	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
	Contracting Organizations and the Need for Written Transfer Obligations and Quality Agreements
	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
	Foolproof Investigations: A Proven Approach for Root Cause Analysis in a Regulated Environment
	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
	How to Successfully Manage Your Suppliers and Ensure Product Safety and Compliance
	ICH Q10 - Pharmaceutical Quality Systems - 'An Opportunity for Us All'
	ISO 14000 Standards
	ISO 15189 Standards: For Medical and Clinical Laboratories
	ISO 17025: What it Means for You and Your Laboratory
	ISO 9001-2000 Standards: Automating Quality Systems
	Managing Change Control to Comply with FDA and EU Regulations
	Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid
	MasterControl: What's the Return on Investment?
	Meeting ISO 9001:2008 - Standards with Automated Tools
	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 Trends in the Medical Device Industry
	SOP Management as a Compliance Tool in FDA and ISO Environments
	Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments
	Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean
	The Basics of ISO 13485
	The Future of the FDA: Operating in an "Electronic World"
	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
	The Top 5 Challenges of BOM Management
	The Value of Studying and Utilizing FDA's QSIT Manual
	Top Five Ways Automation Can Boost Financial Success in the Life Sciences Industries
	Writing and Enforcing Your SOPs for GxP Compliance Success

     Return to Top of Page

---

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 with 21 CFR 820 and ISO 13485 Using MasterControl
	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
	New ICH Q10 Harmonization Guidelines and Opportunities for the Pharmaceutical Industry
	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
	The CAPA Engine and Your QMS System - Is it Driving Your Company Forward?

     Return to Top of Page

---

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 10.0.x Hardware/Software Recommendations
	MasterControl Analytics™
	MasterControl Audit™
	MasterControl CAPA
	MasterControl Change Control™
	MasterControl Customer Complaints™
	MasterControl Document Connections™
	MasterControl Documents™
	MasterControl Nonconformance™
	MasterControl Process™
	MasterControl QAAD link™
	MasterControl Rules™
	MasterControl SOX™
	MasterControl Training™

     Return to Top of Page

---

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
	EMD Chemicals
	Hu-Friedy
	Iowa Blood
	Mallinckrodt Baker
	Namsa
	Schiff Nutrition
	Sorenson Medical
	Stay InFront
	Syncardia Systems
	Teva Pharmaceuticals
	Weider Nutrition

     Return to Top of Page

---

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.

Return on Investment
	The Power of an Integrated Quality Management System (47:47)
MasterControl 8.0
	Creating and Scheduling Customized Reports
	MasterControl Supplier™
MasterControl Partners / Integrations
	Integration of Lorenz docuBridge and MasterControl for Electronic Submissions
	Managing Documents & Submissions Lifecycles with MasterControl and LORENZ Solutions
	Regulated Product Submissions: Preparing for RPS & How will it impact my industry?
	Using Document Templates to Accelerate Time to Submissions with MasterControl and Sage
Improving your Quality Processes
	Automating and Integrating Employee Training Processes to Ensure Compliance
	Integrating ISO 14971 and ICH Q9 Into Your Quality System
	MasterControl - Quality Audit Challenges and Solutions
	Program for Simplifying and Authoring SOPs
	Six Steps to Better Medical Device Labeling: Dividends with Dollar Signs
	Streamlining SOP Document Systems
	The Importance of Effective CAPA and Root Cause Analysis Processes
Regulatory Compliance
	AberdeenGroup - The Cost of Quality: a Study on Life Sciences
	Automating Quality Audits for Regulatory Compliance
	GAMP 5 - A Risk-based Approach to Compliant GxP Computerized Systems
	Overview: Quality System Regulation (QSR)
	Risk Management: FDA Regulated Industries
Product Development and Manufacturing
	Effective Bill of Materials (BOM) Management
	Problem Solving in the Lean Supply Chain
	Project Management Challenges in Medical Device New Product Development
	Simplifying Batch Record Documentation in Preparation for MES/EBR
	Streamlining Batch Record Documentation System in the Life Science Industry
General
	Software as a Service (SaaS) - Is it Right for Your Company?

     Return to Top of Page

---

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
	View Blood & Biologics 3-Minute Demo
	View FDA 3-Minute Demo
	View ISO 3-Minute Demo
	View Medical Device 3-Minute Demo
	View Pharmaceutical 3-Minute Demo

     Return to Top of Page

---

Promotional

	A system that pays you back
	Accelerating Time to Market
	Brochure: MasterControl Audit™
	Brochure: MasterControl Risk™
	Brochure: MasterControl Supplier™
	Getting the Most Out of Your CAPA System
	Global Accounts Program
	How to Save $100 Grand Per Year!
	MasterControl 2010 Presentation Guide
	MasterControl Blood, Biologics, and Clinical Laboratory Solutions
	MasterControl Medical Device Solutions
	MasterControl Pharmaceutical & Biotechnology Solutions
	MasterControl Software Solutions Overview
	MasterControl Version 10.0: What's New?
	MasterControl Version 9.0: What's New?

     Return to Top of Page

---

Analyst Report

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

     Return to Top of Page

---

Free Templates

The following are free basic Word templates to give you a head start on your processes.

	Basic Policy SOP Template (Word Document)
	Basic Procedure SOP Template (Word Document)
	Basic Work Instruction SOP Template (Word Document)
	MasterControl ROI Tool

     Return to Top of Page

---

Document connector

     Return to Top of Page

---

Connection

     Return to Top of Page

---

www.mastercontrol.com/controlpanel

     Return to Top of Page

---