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?

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Creating a Paperless Process Using MasterControl (3:38)
DOCUMENTS
Product Data Sheets
White Papers
Q&As
Tech Papers
Case Studies
 ONLINE RESOURCES
Online Demonstrations
Webinars

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 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 Clinical Suite™
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 Licensing Server™
MasterControl Enterprise Remote File Server™
MasterControl Equipment Calibration™
MasterControl Equipment Maintenance™
MasterControl Exams™
MasterControl Forms Quickview™
MasterControl GCPDocs Express™
MasterControl GCPDocs JumpStart™
MasterControl Guest Connect™
MasterControl Hosted™
MasterControl HR Finance™
MasterControl Incident Reporting™
MasterControl MD™
MasterControl Mobile™
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
Validation Services and Solutions - What Sets MasterControl Apart

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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 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
Annex 11 and 21 CFR Part 11: Comparisons for International Compliance
Annex 11: The EU's New Expectations for Regulated Computerized Systems
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 Regulated Companies Can Improve the Contract Management Process to Increase Efficiency and Reduce Risks
How Regulated Companies Can Leverage Mobile Technologies
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
What the Food Safety Modernization Act (FSMA) Means to the Food and Beverage Industry
What the Revised European Union’s Annex 11 Means to Life Science Companies
Writing and Enforcing Your SOPs for GxP Compliance 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 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 Guidance 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?

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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 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™

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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
EMD Chemicals
Hu-Friedy
Iowa Blood
Mallinckrodt Baker
Namsa
Schiff Nutrition
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.

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?


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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
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

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Promotional



A system that pays you back
Accelerating Time to Market
Brochure: Dealing with QMS Regret
Brochure: MasterControl Audit™
Brochure: MasterControl Clinical Management Software
Brochure: MasterControl Food Safety Quality Management System
Brochure: MasterControl Mobile™
Brochure: MasterControl Risk™
Brochure: MasterControl Simplifies IT Management
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 Quality and Compliance Consulting Overview
MasterControl Quality Management Workshops Course Guide
MasterControl Software Solutions Overview
MasterControl Version 10.0: What's New?
MasterControl Version 9.0: What's New?

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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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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

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Document connector




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Connection




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www.mastercontrol.com/controlpanel




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Sales Presentations

Sales Presentations


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QuickStart Cards

QuickStart Cards


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Japanese Documents

Japanese Documents


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