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MasterControl™リソースセンターでは、製品情報を確認できます。受信したい項目を選択し、ページの下部にある送信ボタンをクリックしてください。ご興味を持ちのリソースは何ですか?



Analyst Report

A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)
Aberdeen: The Cost of Quality: a Study on Life Sciences
Achieving Quality Across the Global Manufacturing Network
Addressing Quality and Manufacturing Challenges in Life Sciences (LNS)
Closed Loop Quality Management: Connecting the Value Chain (LNS)
Risk Management: Best Practices for Medical Device Profitability



Brochure

6 Reasons to Automate Your Batch Record System



コンサルティングサービス

Audit/Assessment: Quality Event Management (QEM)
MasterControl Quality and Compliance Consulting™ (QCC) Certification/Accreditation Assistance Services
MasterControl Quality and Compliance Consulting™ (QCC) New Product Development/Acceptance Services
MasterControl Quality and Compliance Consulting™ (QCC) Quality Management Systems (QMS) Services
MasterControl Quality and Compliance Consulting™ (QCC) Quality Process Training
MasterControl Quality and Compliance Consulting™ (QCC) Regulatory Acceptance/Compliance Services
MasterControl Quality and Compliance Consulting™ (QCC) Services Overview
MasterControl Quality and Compliance Consulting™ (QCC) Supply Chain Management Services
MasterControl Quality and Compliance Consulting™ (QCC) Validation Services
Workshop: Corrective Action/Preventive Action (CAPA), Advanced Problem Solving to Identify and Correct Root Cause
Workshop: Quality Event Management (QEM) and Corrective Action/Preventive Action (CAPA)
Workshop: Quality Management System (QMS) Root Cause Investigations



E-book

(E-Pub Version) Convergence of Compliance & Technology
Compliance and Technology: How to meet changing FDA expectations



無料のテンプレート次に示すのは、プロセスをすぐに開始できる無料の基本的な Word のテンプレートです。

Basic Policy SOP Template (Word Document)
Basic Procedure SOP Template (Word Document)
Basic Work Instruction SOP Template (Word Document)
MasterControl TMF Checklist Template



Infographic

Closed Loop Quality Management
Driving Collaborative Growth in Life Sciences (LNS)
ISO 9001 QMS Structure Diagram
We've Programmed in ROI



Interactive Graphic

9 Pitfalls to Avoid During the Document Control Process
Evolution of a QMS



Poll Reports

Quality System Poll Results: How Do You Compare With Your Quality Peers?



Q&A

Answers to Your Burning Questions about MasterControl
CAP認定制度及び文書管理について
CDERが提供する査察のポイント
FDAのGTP(Good Tissue Practice) に対するコンプライアンス対策
FDA医療機器査察官の査察に関する見識
ISO14971:医療機器メーカーのリスク管理
LORENZ Life Sciences Group and MasterControl Technology Integration FAQ
MasterControl Version 11: Most Frequently Asked Questions Pertaining to Security
MasterControlでのコンプライアンス対策 21 CFR Part 820とISO 13485
Pharmaceutical CGMP for 21st Century
Q&A: Effective Project Management Can Help Ensure Compliance
The CAPA Engine and Your QMS System - Is it Driving Your Company Forward?
医薬品cGMP規制における品質システムの アプローチに関するFDAガイダンス
欧州医療機器安全性監視システム (MEDDEV.rev. 5)に関するガイドライン
製薬企業向け FDAのQ9ガイダンスにおける リスクマネジメント
製薬業界における新しいICH Q10ガイダンス (医薬品品質システム)について



Toolkit

10 Free Resources to Boost Your Training Management System
11 Free Resources to Boost Your FDA Readiness
11 Free Resources to Boost Your Medical Device FDA Readiness
12 Free Resources to Boost Your Pharmaceutical FDA Readiness
12 Free Resources to Boost Your Supplier Management System
25 Free Resources to Boost Your Quality Management System
8 Free Resources to Boost Your Audit Management System
9 Free Resources to Boost Your CAPA Management System
9 Free Resources to Boost Your Document Control System
IT Toolkit for Implementing an EQMS
MasterControl ROI Toolkit for EQMS Implementation



インターアクティブ/ライブデモンストレーション

MasterControl Clinical Quality Management System (CQMS)
MasterControl Quality Management System (QMS) Overview



ウェブセミナー

一般


ISO 13485:2016 Part 2: Getting Ready for Change
Software as a Service (SaaS) - Is it Right for Your Company?



品質プロセスの改善


CAPA Part 3: Effectiveness Checking and Management Review
Automating and Integrating Employee Training Processes to Ensure Compliance
Best Practices in Post-Market Intelligence
CAPA Part 1: Improving CAPA Systems with a Closed-loop Methodology
CAPA Part 2: Taking Effective Action
Integrating ISO 14971 and ICH Q9 Into Your Quality System
ISO 9001:2015 Part 1: Prepare for Impending Changes
ISO 9001:2015 Part 2: New QMS Structure Overview
ISO 9001:2015 Part 3: Risk-based Thinking Goes from Implicit to Explicit
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



MasterControl 8.0


MasterControl


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
アズビル株式会社:プロジェクト管理の電子化
富士通株式会社:文書管理、品質イベント管理の導入事例



製品開発・製造


Effective Bill of Materials (BOM) Management
Improving Supplier 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



規制・規格に対するコンプライアンス


AberdeenGroup - The Cost of Quality: a Study on Life Sciences
Automating Quality Audits for Regulatory Compliance
FDA Just Left! Now What?
GAMP 5 - A Risk-based Approach to Compliant GxP Computerized Systems
ISO 13485:2016 Part 1: Getting Ready for Changes
Overview: Quality System Regulation (QSR)
The FDA Called! Now What?
Working on a Post-Inspection FDA Response



投資対効果(ROI)


The Power of an Integrated Quality Management System (47:47)

ケーススタディー

Aplicare
ARUP Laboratories
Asymtek
Bio-Imaging
Ecolab’s MasterControl System Continues to Grow
EMD Chemicals
How Ash Stevens Inc. Boosted Its Equipment Calibration and Maintenance Compliance
Hu-Friedy
Iowa Blood
ITxM Marks 10-Year Milestone of MasterControl Usage
Mallinckrodt Baker
Megadyne Medical Products - Successful Regulatory Compliance
MicroMed Case Study
Namsa
On-Site Training Complements MD Anderson’s Implementation
Schiff Nutrition
Sorenson Medical
Stay InFront
Syncardia Systems
Teamwork Key to OPK Biotech’s Successful Implementation
Teva Pharmaceuticals
Unity Lab Services: Assurance of Current Content is Crucial to Success
User Acceptance is Key to GOLM’s Successful Implementation
Validation a Focal Point in LifeCenter Northwest’s Implementation
Weider Nutrition
Zarbee’s Naturals Taps MasterControl Spark™
アクテリオン ファーマシューティカルズ - Quatroシステム
バスクテック



テクニカルペーパー
テクニカルペーパー

15 Questions for Preparing to Integrate with MasterControl
MasterControl Version 11.6 Hardware/Software Recommendations



プロダクトデータシート

MasterControl ~様々な言語に切り替えが可能~
MasterControl Accessibility Standards for Section 508 Compliance Product Data Sheet
MasterControl Accident/Injury™
MasterControl Advanced Packet Types™
MasterControl All Access Product Summary
MasterControl Analytics™
MasterControl API Toolkit: Integrate Your EQMS with Core Business Solutions
MasterControl API Toolkit™
MasterControl Audit Essentials™
MasterControl Audit™
MasterControl BOM™
MasterControl Business Process Library™
MasterControl Café
MasterControl CAPA
MasterControl Change Control
MasterControl Classes™
MasterControl Clinical Quality (GCP) JumpStart
MasterControl Clinical Quality Management System (CQMS)™”
MasterControl Collaboration™
MasterControl Copies™
MasterControl Customer Complaints
MasterControl Custom-Fit
MasterControl Deviations
MasterControl DHF JumpStart
MasterControl Document Collections™
MasterControl Document Connections™
MasterControl Documents™
MasterControl Education Services – On Demand Training™
MasterControl Educational Services
MasterControl Electronic Batch Records™ (EBR)
MasterControl eMDR™
MasterControl Enterprise Business Units™
MasterControl Enterprise Integrations™
MasterControl Enterprise Quality Management Software (EQMS)
MasterControl Equipment Calibration™
MasterControl Equipment Maintenance™
MasterControl Escrow Program
MasterControl eTMF Manager™
MasterControl Event Analyzer
MasterControl Exams™
MasterControl Flexible Options - Licensing/Packaging/Installation/Scale
MasterControl Forms QuickView™
MasterControl GCP Studies™
MasterControl GCPDocs Express™
MasterControl GLP JumpStart™
MasterControl GLP Studies™
MasterControl GMP JumpStart
MasterControl Government Contract Vehicles
MasterControl Guest Connect™
MasterControl Hosted™
MasterControl HR Finance™
MasterControl Incident Reporting™
MasterControl JumpStarts and Reference Models Overview
MasterControl Mobile™
MasterControl MS Word Integration™
MasterControl New Implementation Subscription Services
MasterControl Nonconformance™
MasterControl Not-for-Profit Pricing
MasterControl Organizer Gateway™
MasterControl Outlook E-mail Integration™
MasterControl Out-of-Specification™
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 JumpStart
MasterControl Portal™
MasterControl Process™
MasterControl Project Management Services
MasterControl Projects™
MasterControl Promotional Materials™
MasterControl PTC® PDM Connectors
MasterControl QE Audit
MasterControl QEM CAPA Workshop
MasterControl QMS and QEM Systems for ISO Guided Companies
MasterControl Recorded Online Training™
MasterControl Reference Model™ - EDM Jumpstart
MasterControl Reference Model™ - TMF Jumpstart
MasterControl Regulatory Suite™
MasterControl Risk Analysis™
MasterControl Risk™
MasterControl ROI Worksheet - Calculate Your ROI
MasterControl Rules™
MasterControl SharePoint Connector™
MasterControl SolidWorks® PDM Connectors
MasterControl Solutions™ Overview
MasterControl Spark Implementation Schedule
MasterControl Spark Implementation Schedule for Regulated Companies
MasterControl Spark Overview
MasterControl Submissions Locker™
MasterControl Submissions Ready™
MasterControl Suite Overview
MasterControl Supplier Corrective Action Request (SCAR)™
MasterControl Supplier Deviation™
MasterControl Supplier Scorecard™
MasterControl Supplier™
MasterControl Sysadmin Support
MasterControl Technical Account Manager (TAM) Program
MasterControl Training™
MasterControl Transfer OQ™
MasterControl Transfer Performance Qualification (TPQ)
MasterControl Validation Strategy and Advantages
MasterControl Validation Strategy FAQ
MasterControl Variance™
MasterControl バリデーションサービスについて
MasterControl/Kofax Interface™
MasterControl/PleaseReview Collaboration
QMS MasterControl CAPA Workshop for ISO Guided Companies
QMS MasterControl Root Cause Investigations Workshop for ISO Guided Companies
Trial Site Workshop
UL Compliance to Performance Advisory Services Company Profile and Partner Strategy
UL Compliance to Performance Courses from MasterControl
Validation Services and Solutions - What Sets MasterControl Apart



プロモーション
プロモーション

Brochure: Dealing with QMS Regret
Brochure: Is CAPA Confusion Leaving You Feeling Lost?
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™
Brochure: MasterControl Training at Your Fingertips
Building QEM Process Forms? MasterControl’s Process Bundles Will Save You a Bunch
Custom Process Maintenance Subscription
Dovel-MasterControl Government Contract Vehicles
Global Accounts Program
How to Save $100 Grand Per Year!
MasterControl 2010 Presentation Guide
MasterControl Blood, Biologics, and Clinical Laboratory Solutions
MasterControl Cloud
MasterControl Corporate Brochure
MasterControl EQMS - Delivering a Great User Experience
MasterControl Medical Device Solutions
MasterControl Pharmaceutical & Biotechnology Solutions
MasterControl Quality Management Workshops Course Guide
MasterControl Software Solutions Overview
MasterControl’s ROI: A system that pays you back!
Take Shelter in MasterControl Hosted™
The Smart Executive's



ホワイトペーパー

21 CFR Part 11 Risk of Non-compliance
21 CFR Part 11 System Validation (Risk Management Plan)
21 CFR Part 11: MasterControl Product Positioning
21 CFR Part 11:FDA査察の準備はできてますか?
5 Tips for Getting Executive Backing for a New or Expanded EQMS
5 Trends Medical Device Companies Can’t Afford to Ignore in 2016
5 Ways MasterControl Ensures System Compliance with 21 CFR Part 11
9 Pitfalls to Avoid During the Document Control Process
Annex 11:規制対象となるコンピューター化されたシステムに対するEUの期待
Automating Document Control Processes
Automating Electronic Engineering Change
Automating Quality Compliance and Business Process within the Food and Beverage Industry
Automating Training Control Processes
BOM管理の課題 『TOP 5』
Calibration Software: The Buck Starts at User Requirements
cGMP and ISO 13485 Integrated Quality Management System
Compliance and Traceability in Regulated Industries Benchmark Report
Contracting Organizations and the Need for Written Transfer Obligations and Quality Agreements
Cost of Inaction - Taking Quality Management Processes Digital
Debunking 5 Common Assumptions About Quality in Business and Life in General
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
eTMF Management Essentials
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
FDA Inspections of Clinical Investigators: Are You Ready?
FDAやISOの要求事項を順守した苦情管理
FDA及びISO対策をマネジメントシステムで最適化する6つのポイント
Final FDA Rule on Dietary Supplements - 21 CFR Part 111
Five Pharma Trends that Will Have the Biggest Impact in 2017
Five Trends Transforming the Medical Device Industry in 2014
Five Trends Transforming the Medical Device Industry in 2015
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
GLP信頼性保証業務をソフトウェアで管理するメリット『TOP 5』比較
How 21 CFR Part 111 Helps Dietary Supplement Companies
How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market
How Effective Training Management Can Help You Prevent Quality Issues
How Medical Device Firms Can Adapt to New Excise Tax
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 Address the Top 6 Pains in DHF Management
How to Kick-Start Your CAPA Process
How to Successfully Complete an FDA Inspection
How to Successfully Manage Your Suppliers and Ensure Product Safety and Compliance
How to Use Risk-Based Monitoring and Clinical CAPA to Ensure Compliance
ICH Q10 - Pharmaceutical Quality Systems - 'An Opportunity for Us All'
ISO 13485 -- Change? Do I Have To??
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
ISO9001: 2008要求事項をソフトウェアで順守
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?
Multipurpose Tool v. Integrated Best-of-Breed Modules: What’s the Difference?
Noncompliance to FDA Quality Standards: What's the Risk to Executives?
Pragmatic Approach to Computer Systems Validation
Qualifying Clinical Site Personnel Using Embedded Automation
Reducing the Documentation Burden in FDA Design Control
Sarbanes Oxley Compliance - Challenges and Solutions for Sustained Compliance
Simplifying CAPA: Seven Steps
Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments
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 Inspectional Observations in Pharmaceutical 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 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 Pros and Cons of Buying Vs. Building a Quality Management System
The Value of Studying and Utilizing FDA's QSIT Manual
Top 10 Best Practices for Building Forms
Top 3 Strategies for Complying with USP <795> & USP <797>
Top 5 Trends in the Medical Device Industry in 2017
Top 5 Trends in the Pharmaceutical Industry in 2015
Top Five Ways Document Automation Can Boost Financial Success in Life Sciences Industries
Understanding ISO 13485: A Brief, Yet Comprehensive, Overview
What is the True Cost of Not Having an EQMS?
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
クリニカルCAPA:臨床研究と品質の融合
品質監査:継続的な改善とコンプライアンス対策の手法として
国際規制の比較:Annex 11 & 21 CFR Part 11
変更管理 ~FDA及びISO環境における継続的な品質改善~
本当にCAPAを実施していますか?FDA規制に於ける予防措置と是正措置
治験に要するコスト削減や時間短縮に貢献する品質及びコンプライアンスのあり方
治験依頼者とCROとの間のパートナーシップ:その効果的な体制構築に直面する課 題