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Centre de ressources


Le centre de ressources MasterControl™ rassemble les ressources relatives aux produits de votre choix. Sélectionnez les documents que vous souhaitez recevoir, puis validez votre choix en bas de la page. Quelles ressources recherchez-vous ?



Brochure

6 raisons d'automatiser votre système d'enregistrement par lot



Consulting

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



Démo video

MasterControl Clinical Quality Management System (CQMS)
Présentation du système de gestion de la qualité (QMS) MasterControl



Livre électronique

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



Etude de cas

Actelion's Quatro System
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
Vascutek
Weider Nutrition
Zarbee’s Naturals essaie MasterControl Spark™



Fiches produits

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
MasterControl Audit Essentials™
MasterControl Bill of Materials (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™
Documents MasterControl
MasterControl Documents and Training Validation Subscription Services
MasterControl Education Services – On Demand Training™
MasterControl Educational Services
MasterControl Electronic Batch Records™ (EBR)
MasterControl eMDR™
MasterControl Enterprise Business Units™
MasterControl Enterprise Integrations™
Logiciel MasterControl de gestion de la qualité en entreprise (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
Outils de passation de marchés MasterControl pour le gouvernement
MasterControl Guest Connect™
MasterControl Hosted™
MasterControl Hosted™ Do’s & Don’ts
MasterControl HR Finance™
MasterControl Incident Reporting™
MasterControl JumpStarts and Reference Models Overview
MasterControl Mobile™
MasterControl MS Word Integration
MasterControl Multi-Language Translations
MasterControl New Implementation Subscription Services
MasterControl Non conformité
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 Registrations™
MasterControl Registrations™ for eCTD
MasterControl Regulatory Suite™
MasterControl Risk
MasterControl Risk Analysis™
MasterControl ROI Worksheet - Calculate Your ROI
MasterControl Rules™
MasterControl SharePoint Connector™
MasterControl SolidWorks® PDM Connectors
Présentation de MasterControl Solutions™
MasterControl Spark Implementation Schedule
MasterControl Spark Implementation Schedule for Regulated Companies
MasterControl Spark Overview
MasterControl Submissions Locker™
MasterControl Submissions Ready™
MasterControl Suite Overview
Fournisseur MasterControl
MasterControl Supplier Corrective Action Request (SCAR)™
MasterControl Supplier Deviation™
MasterControl Supplier Scorecard™
MasterControl Sysadmin Support
MasterControl Technical Account Manager (TAM) Program
Formations MasterControl
MasterControl Transfer OQ™
MasterControl Transfer Performance Qualification (TPQ)
MasterControl Validation Strategy and Advantages
MasterControl Validation Strategy FAQ
MasterControl Variance™
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
UL Training Course: GMP Inspection Readiness for Pharmaceutical Companies
UL Training Course: IT Validation
UL Training Course: Pharmaceutical GMP Compliance
Validation Services
Validation Services and Solutions - What Sets MasterControl Apart



Fiches techniques

15 questions pour préparer l'intégration de MasterControl
MasterControl Version 11.6 Hardware/Software Recommendations



Infographie

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



Interactive Graphic

9 écueils à éviter durant le processus de contrôle des documents
Evolution of a QMS



Modèles gratuit

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



Poll Reports

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



Promotions

Brochure: Dealing with QMS Regret
Brochure : Les CAPA vous semblent trop confus ?
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 : Formations MasterControl à portée de main
Building QEM Process Forms? MasterControl’s Process Bundles Will Save You a Bunch
Souscription à la maintenance personnalisée des processus
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 - Proposer une expérience utilisateur exceptionnelle
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™
Guide du responsable intelligent



Q&R

Réponses à vos questions brûlantes concernant MasterControl
CAP Accreditation and Document Control
CDER Official Offers Tips on GMP Inspections
Compliance with FDA's Good Tissue Practices
FDA Medical Device Investigator Offers Insights on Inspection
FDA's Quality Systems Approach to Pharmaceutical CGMPs
Gestion des risques pour les entreprises pharmaceutiques soumises à la ligne directrice Q9 de la FDA
Guidelines For The European Medical Device Vigilance System
How MasterControl Addresses HIPAA Challenges
LORENZ Life Sciences Group and MasterControl Technology Integration FAQ
MasterControl Version 11: Most Frequently Asked Questions Pertaining to Security
New ICH Q10 Harmonization Guidance for the Pharmaceutical Industry
Bonnes pratiques de fabrication dans l'industrie pharmaceutique au 21e siècle
Q&A: Effective Project Management Can Help Ensure Compliance
Questions - réponses : Mise en conformité avec la réglementation CFR 21 part 820 et la norme ISO 13485 à l'aide de MasterControl
Questionsréponses : ISO 14971 : gestion des risques pour les entreprises fabriquant des dispositifs médicaux
The CAPA Engine and Your QMS System - Is it Driving Your Company Forward?



Rapport d'analyse

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



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



Webinar

Général


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



Amélioration de vos processus qualité


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 Partie 1 : Préparation aux changements imminents
ISO 9001:2015 Partie 2 : Présentation de la nouvelle structure du QMS
ISO 9001:2015 Part 3 : Réflexion en matière de risque, d'implicite à explicite
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


Partenaires/Intégrations 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



Développement et fabrication de produits


Effective Bill of Materials (BOM) Management
Améliorer la gestion des fournisseurs
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



Conformité règlementaire


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 Partie 1 : Préparation aux changements
Overview: Quality System Regulation (QSR)
The FDA Called! Now What?
Working on a Post-Inspection FDA Response



Retour sur investissement


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

White Paper

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 conseils pour obtenir le soutien de la direction à un nouveau système EQMS ou à l'extension d'un système EQMS existant
5 Trends Medical Device Companies Can’t Afford to Ignore in 2016
5 Ways MasterControl Ensures System Compliance with 21 CFR Part 11
9 écueils à éviter durant le processus de contrôle des documents
Annex 11: The EU's New Expectations for Regulated Computerized Systems
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 - Continuous Quality Improvement in FDA and ISO Environments
Clinical CAPA: Embedding Quality into Clinical Research
Complaint Handling as an Integral Part of FDA and ISO Compliance
Compliance and Traceability in Regulated Industries Benchmark Report
Comprendre la norme ISO 13485 : présentation rapide mais complète
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
Dix signes indiquant que votre patron ne maîtrise toujours pas les concepts d’ISO 9001 et de Lean
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?
Final FDA Rule on Dietary Supplements - 21 CFR Part 111
Five Pharma Trends that Will Have the Biggest Impact in 2017
Cinq tendances transformant le secteur des dispositifs médicaux en 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
Gestion des procédures opérationnelles normalisées (SOP) : un outil de conformité dans les environnements FDA et ISO
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 Effective Training Management Can Help You Prevent Quality Issues
How Medical Device Firms Can Adapt to New Excise Tax
How Quality and Compliance Can Help Reduce the Cost and Time Involved in Executing Clinical Trials
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 – Le changement est-il obligatoire ?
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
Les cinq avantages clés de la gestion électronique des audits et des bonnes pratiques de laboratoire (BPL)
Livre blanc : 21 CFR Part 11 Êtes-vous prêt pour une inspection FDA ?
Livre blanc : Audit Qualité - Un outil au service de l'amélioration continue et de la conformité
Livre blanc : Automatisation des processus de contrôle des documents pour répondre aux exigences de la FDA et de l'ISO : Augmenter l'efficacité, garantir la conformité et améliorer la rentabilité
Livre blanc : Conformité au niveau international : comparaison des réglementations Annex 11 et CFR 21 part 11
Livre blanc : Et si votre système CAPA avait besoin d'une CAPA? Automatisation des actions correctives et préventives dans les environnements FDA
Livre blanc : optimisez votre système de gestion de la qualité et conformez-vous aux réglementations de la FDA et de l'ISO en six étapes
Livre blanc : Satisfaire aux normes ISO 9001:2008 avec des outils automatisés
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
Simplification des CAPA : sept étapes pour établir un plan CAPA complet
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
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
The Challenges of Building an Effective Structure for Sponsor-CRO Partnership
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 Top 5 Challenges of BOM Management
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
Cinq façons d'augmenter son chiffre d'affaires dans le secteur des sciences de la vie avec la gestion automatisée des documents
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