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) 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. MasterControl Advanced Packet Types™ MasterControl Analytics™ MasterControl API Toolkit™ MasterControl ASP™ MasterControl Audit™ MasterControl Bill of Materials™ MasterControl Business Process Library™ MasterControl CAPA MD™ MasterControl CAPA Pharma™ MasterControl CAPA™ MasterControl Change Control™ MasterControl Collaboration™ MasterControl Configuration Services (for customers only) 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 Educational Services MasterControl Electronic Batch Records™ MasterControl eMDR™ MasterControl ENG™ (FDA) MasterControl Enterprise™ MasterControl Equipment Calibration™ MasterControl Equipment Maintenance™ MasterControl Exams™ MasterControl Express Biologics™ MasterControl Forms Quickview™ MasterControl GCPDocs Express™ MasterControl GCPDocs JumpStart™ MasterControl Global Licensing Server™ MasterControl HR/Finance™ MasterControl Maintenance Service Agreement 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 Project Management Services MasterControl Projects™ MasterControl Publishing™ MasterControl QAAD API™ MasterControl QAAD™ MasterControl QMS CAPA Solutions™ MasterControl QMS CAPA Workshop™ MasterControl QMS Root Cause Investigations Workshop™ MasterControl Risk Analysis™ MasterControl Rules™ MasterControl SharePoint Connector™ MasterControl Submissions Gateway™ MasterControl Submissions Locker™ MasterControl Submissions Ready™ MasterControl Supplier Deviation™ MasterControl Supplier™ MasterControl TotalMFG™ MasterControl TotalPharma™ MasterControl Training™ MasterControl Transfer OQ™ MasterControl™ Solutions Overview MasterControl/Datafarm GxP2eCTD Connector MasterControl/Kofax Interface™ MasterControl/PleaseReview Collaboration 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 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 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 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 9001-2000 Standards Managing Change Control to Comply with FDA and EU Regulations Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid Managing the Document Lifecycle from Creation to eSubmission and Beyond MasterControl: What's the Return on Investment? 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 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      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 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™      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 How to Save $100 Grand Per Year! Hu-Friedy Iowa Blood Mallinckrodt Baker Namsa 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 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 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 Six Steps to Better Medical Device Labeling: Dividends with Dollar Signs 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 MasterControl Resource Presentation MasterControl Executive Presentation      Return to Top of Page Promotional A system that pays you back Accelerating Time to Market      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 Tech Brief      Return to Top of Page 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. Return to Top of Page

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