Document Control Management System

Size: px
Start display at page:

Download "Document Control Management System"

Transcription

1 Document Control Management System

2 DocXellent is a leading provider of electronic document control software and quality software applications with over 30 years of experience. We design our products to be configurable allowing our customers to organize their electronic document control and quality management functions the way they operate. Electronic Document Control and Quality Management Software Document Control Quality Management CAPA Training Management Packaging Management Specification Management Change Control Intellectual Property Control Ensur ensur is an easy-to-use, commercialoff-the-shelf, web-based Document Control and Quality Management Software System that is purpose built to manage your documents in an efficient and cost effective manner. We can help you with packaging management, specification management and document version control If your company currently manages document versions and life-cycles manually using spreadsheets, using ensur will dramatically improve the efficiency of your current process and will pay for itself in a matter of months. Our highly configurable quality control software solution will map to your business policies and procedures allowing you to customize our system the way you currently operate or want to change to in the future. Your document version control, workflow, change controls, packaging specifications, SOPs, nonconformance investigations, CAPAs, training, and other quality procedures are swiftly automated by ensur.

3 ensur Overview Don t Let Quality Be the Missing Piece ensur is an easy-to-use, configurable, commercial-off-the-shelf, web-based Document Control and Quality Management Software System that will dramatically help you to improve and manage the efficiency of paper based or uncontrolled electronic file based processes. ensur helps companies exceed regulatory compliance goals regardless of the entity that oversees them. Whether companies are regulated by FDA, ISO, SQF, or OSHA, ensur keeps organizations compliant while reducing operating costs. ensur s multi-layered security model and comprehensive audit trail keeps your documents in the hands of only the people with the proper rights to access them. You will be able to see every action of every individual within a few clicks. ensur gives you the ability to limit the actions and content your employees can create, edit or view. Most importantly, ensur takes away the worry that your employees are working with obsolete documents. The intuitive interface and ease of use will keep your employees productive and reduce the waste and cost of your existing system or manual process. From purchase to go-live, the DocXellent team is ready to help you exceed your quality goals through superior service and support. A great product that has saved us time and kept us compliant with the FDA and ISO. Great for multiple locations and business units. Roland Bessette Alere, Inc.

4 Comprehensive Security Model Electronic Signatures Change Management Specification Management Revision Control ISO/FDA Compliant Configurable Workflow Interactive Web Forms Designer CAPA Management Electronic Training Records Easy to Learn User Interface Training Comprehension Assessments Audit Trails Automatic PDF Generation Personalized To-Do Lists Action Item Management Controlled Printing Bill of Material Management Extensive Search Capabilities Document Binding and Publishing Vendor/Supplier Collaboration Analytical Reporting Capabilities Notifications Public Searches Adverse Event Handling Deviation Tracking PDF Overlays and Watermarking Comprehensive Linking Model

5 Service + Support When you buy a software product after you are drawn into it by its features and benefits, one important aspect of your purchase is the ongoing support. At DocXellent, our support model is our best feature. Besides having a feature rich, configurable and user friendly application called ensur, our support team is stellar. Testament to that is you can ask any customer we ve ever had and the message is the same, they have excellent, highly responsive and friendly support. Support comes in many types; initial installation, help in configuring ensur based on how you want to use the software, validation services, training and lastly, once it s in full use in your organization, answering s and support questions about its daily use. All get the same attention and priority. No need to elevate the call to a higher support tier, if our Customer Support team needs to consult with our Technical team, they elevate the incident immediately. Investigation, collaboration and hard work lead to solutions.

6 Contact Us 309 Otrobando Avenue Norwich, CT United States Tel: (860) Fax: (860)

Document Change Control

Document Change Control Document Change Control for Quality & Regulatory Compliance Quality and Compliance Solutions Document Control Software for Microsoft Windows Document Change Control Improve efficiency and enforce consistency

More information

ComplianceSP TM on SharePoint. Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013

ComplianceSP TM on SharePoint. Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013 TM ComplianceSP TM on SharePoint Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013 Overview With increasing pressure on costs and margins across Life Sciences, the industry

More information

Complete Document & Process Management for Life Sciences on SharePoint 2010

Complete Document & Process Management for Life Sciences on SharePoint 2010 TM ComplianceSP TM on SharePoint 2010 Complete Document & Process Management for Life Sciences on SharePoint 2010 Overview With increasing pressure on costs and margins across Life Sciences, the Industry

More information

M-Files QMS. Out-of-the-Box Solution for Daily Quality Management

M-Files QMS. Out-of-the-Box Solution for Daily Quality Management M-Files QMS Out-of-the-Box Solution for Daily Quality Management Topics How we see Quality Management Benefits of a dedicated QMS M-Files QMS system essentials Built-in electronic and digital signing QMS

More information

REGULATORY INFORMATION INSTANTLY ACCESS

REGULATORY INFORMATION INSTANTLY ACCESS Introducing CSC s FirstDoc Suite, the life sciences industry s #1 document management and collaboration solution for simplifying global regulatory compliance INSTANTLY ACCESS REGULATORY INFORMATION Are

More information

Product Life Cycle Management

Product Life Cycle Management Engineering Change Control Systems (atecc) Product Life Cycle Management Enterprise information boundaries are disappearing as corporations open their networks to allow external access by manufacturing

More information

AssurX Makes Quality & Compliance a Given Not Just a Goal

AssurX Makes Quality & Compliance a Given Not Just a Goal AssurX Makes Quality & Compliance a Given Not Just a Goal TRACK. MANAGE. AUTOMATE. IMPROVE. AssurX s powerfully flexible software unites and coordinates information, activities and documentation in one

More information

Document Management & Control

Document Management & Control Document Management & Control ibpms Business Process Applications (BPAs) are the innovative, new class of Service Oriented Business Applications (SOBAs) that help businesses automate and simplify the management

More information

Document Management Solution (EDMS)

Document Management Solution (EDMS) Implementing TrackWise with an Electronic Document Management Solution (EDMS) Alex Kotikovsky Product Manager Sparta Systems Gilad Kigel Manager, Solutions Consulting Sparta Systems Agenda Document Management

More information

Quality Control of your Products in Dynamics AX2012 With Total Quality Control Management. Page 1 2 3 4 5 6 7 8 9 10

Quality Control of your Products in Dynamics AX2012 With Total Quality Control Management. Page 1 2 3 4 5 6 7 8 9 10 Quality Control of your Products in Dynamics AX2012 With Total Quality Control Management A puzzle isn t right if the last piece doesn t fit You buy, make, and sell your products in Dynamics AX. Consider

More information

Risk-Based Approach to 21 CFR Part 11

Risk-Based Approach to 21 CFR Part 11 3109 W. Dr. Martin Luther King, Jr. Blvd., Suite 250 Tampa, FL 33607 USA Tel: 813/960-2105 Fax: 813/264-2816 www.ispe.org Risk-Based Approach to 21 CFR Part 11 The 21 CFR Part 11 regulation is a comprehensive

More information

Signature Authentication

Signature Authentication Signature Authentication aka: How to stop chasing after your clinical staff for signatures Elizabeth Nista, CQIA The Written Signature as a Validation Tool Signature is a requirement of multiple accrediting

More information

4Sight Calibration Management Software

4Sight Calibration Management Software GE Measurement & Control Solutions 4Sight Calibration Management Software 4Sight calibration and maintenance management software provides visibility to the assets, data, and resources that affect maintenance,

More information

GxP Process Management Software. White Paper: Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations

GxP Process Management Software. White Paper: Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations GxP Process Management Software : Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations Most FDA violations involve one of the following: Not having procedures in a regulated area

More information

Product Lifecycle Management in the Medical Device Industry. An Oracle White Paper Updated January 2008

Product Lifecycle Management in the Medical Device Industry. An Oracle White Paper Updated January 2008 Product Lifecycle Management in the Medical Device Industry An Oracle White Paper Updated January 2008 Product Lifecycle Management in the Medical Device Industry PLM technology ensures FDA compliance

More information

Quality Management Software >>

Quality Management Software >> Fact Sheet Quality Management Software Understanding today and planning for tomorrow Our suite of Quality and Continual Improvement modules are designed to help your company automate its journey toward

More information

Task Manager. Task Management

Task Manager. Task Management Task Management ibpms Business Process Applications (BPAs) are the innovative, new class of Service Oriented Business Applications (SOBAs) that help businesses automate and simplify the management of missioncritical,

More information

How To Manage Time And Expense On A Computer Or Tablet Or Ipad Or Ipa Or Ipo Or Ipod Or Ipode Or Ipro Or Ipor Or Ipora Or Ipore Or Ipot Or Ipos Or Ipom Or Ip

How To Manage Time And Expense On A Computer Or Tablet Or Ipad Or Ipa Or Ipo Or Ipod Or Ipode Or Ipro Or Ipor Or Ipora Or Ipore Or Ipot Or Ipos Or Ipom Or Ip M4 Systems Advanced Time and Expense Management Brochure M4 Systems Ltd Tel: 0845 5000 777 International: +44 (0)1443 863910 www.m4systems.com www.dynamicsplus.net Table of Contents Introduction ------------------------------------------------------------------------------------------------------------------

More information

Document and Data Control

Document and Data Control Document and Data Control An Integral Component of Quality Management Companies that produce products with rigorous quality requirements face numerous challenges associated with meeting quality objectives

More information

LOW RISK APPROACH TO ACHIEVE PART 11 COMPLIANCE WITH SOLABS QM AND MS SHAREPOINT

LOW RISK APPROACH TO ACHIEVE PART 11 COMPLIANCE WITH SOLABS QM AND MS SHAREPOINT LOW RISK APPROACH TO ACHIEVE PART 11 COMPLIANCE WITH SOLABS QM AND MS SHAREPOINT Implementation of MS SharePoint provides companywide functionalities for general document management and workflow. The use

More information

Taking the pain out of Risk and Compliance Management Systems. Presented by Andrew Batten 23 April 2015

Taking the pain out of Risk and Compliance Management Systems. Presented by Andrew Batten 23 April 2015 Taking the pain out of Risk and Compliance Management Systems Presented by Andrew Batten 23 April 2015 Operational Improvement Technology Solutions Providing consultancy services Gap assessments Food standard

More information

TrackWise - Quality Management System

TrackWise - Quality Management System TrackWise - Quality Management System Focus area: Electronic Management of CAPA Systems in the Regulated Industry May 11, 2007 Yaniv Vardi VP, Operations Sparta Systems Europe, Ltd. Agenda Sparta Systems

More information

HOW TO COMPARE AND SELECT A CHEMICAL INVENTORY MANAGEMENT SYSTEM WHITE PAPER

HOW TO COMPARE AND SELECT A CHEMICAL INVENTORY MANAGEMENT SYSTEM WHITE PAPER HOW TO COMPARE AND SELECT A CHEMICAL INVENTORY MANAGEMENT SYSTEM WHITE PAPER INTRODUCTION Many research organizations are facing a maelstrom of increasing regulation concerning on-site chemicals and an

More information

ABC Farms. ISO 14001 - Environmental Management System Manual. Prepared By: Approved By: Signature: Date:

ABC Farms. ISO 14001 - Environmental Management System Manual. Prepared By: Approved By: Signature: Date: ABC Farms ISO 14001 - Environmental Management System Manual Prepared By: Approved By: Signature: Date: / / / Page 2 of 8 SECTION 0 - TABLE OF CONTENTS MANUAL ISO SECTION SECTION TITLE PAGE SECTION 0 TABLE

More information

Simple, smart, intuitive policy management

Simple, smart, intuitive policy management Product Overview Policy & Procedure Management Workflow I had a policy that I was able to get into the system, reviewed by the various policy owners, approved by the committee, and out for staff to use

More information

GxP Process Management Software. White Paper: Software Automation Trends in the Medical Device Industry

GxP Process Management Software. White Paper: Software Automation Trends in the Medical Device Industry GxP Process Management Software : Software Automation Trends in the Medical Device Industry Introduction The development and manufacturing of a medical device is an increasingly difficult endeavor as competition

More information

Regulated Documents. A concept solution for SharePoint that enables FDA 21CFR part 11 compliance when working with digital documents

Regulated Documents. A concept solution for SharePoint that enables FDA 21CFR part 11 compliance when working with digital documents Regulated Documents A concept solution for SharePoint that enables FDA 21CFR part 11 compliance when working with digital documents Contents Life science industry challenges Regulated Documents our service

More information

Bringing Safe and Cost Effective Products to Market

Bringing Safe and Cost Effective Products to Market Industry Solutions Life Sciences Engineering, Project Collaboration, Document Control and Facilities Management Solutions across the Life Sciences Value Chain Industry Solutions Life sciences companies

More information

Contract Event Management

Contract Event Management Boost Your Competitive Advantage and Reduce the Administrative Costs Surrounding Pharmaceutical contract management departments are charged with managing and determining the impact of complex rebate calculations

More information

Moving From a Spreadsheet to a Document Control Software System A Case Study

Moving From a Spreadsheet to a Document Control Software System A Case Study 2009 Moving From a Spreadsheet to a Document Control Software System A Case Study Mystic Management Systems, Inc. 1/1/2009 Executive Summary TAC was using a labor intensive manual process to manage their

More information

Digitally transforming the medical device lifecycle

Digitally transforming the medical device lifecycle Digitally transforming the medical device lifecycle Siemens PLM Software www.siemens.com/plm Product lifecycle management (PLM) is the only mission-critical business initiative capable of helping medical

More information

Considerations for Management of Laboratory Data

Considerations for Management of Laboratory Data Considerations for Management of Laboratory Data 2003 Scientific Computing & Instrumentation LIMS Guide, November 2003 Michael H Elliott Drowning in a sea of data? Nervous about 21 CFR Part 11? Worried

More information

CRM Dynamics. Dynamic Forms Solution - White Paper

CRM Dynamics. Dynamic Forms Solution - White Paper Dynamic Forms Solution - White Paper V.1.2 Keren Haberman Contents Why Dynamic Forms Solution?... 3 Benefits Provided by the Dynamic Forms Solution... 4 Key Features of Dynamic Forms Solution... 5 Page

More information

Quality Management Software >>

Quality Management Software >> Fact Sheet Quality Management Software Understanding today and planning for tomorrow Our suite of Quality and Continual Improvement modules are designed to help your company automate its journey toward

More information

Product Complaints Management. Infosys Handbook for Life Sciences

Product Complaints Management. Infosys Handbook for Life Sciences Product Complaints Management Infosys Handbook for Life Sciences Table of Contents Introduction 3 Infosys Point of View 4 Success Story - Complaint management for one of the world s top 5 bio-pharmaceutical

More information

Field Service in the Cloud: Solving the 5 Biggest Challenges of Field Service Delivery

Field Service in the Cloud: Solving the 5 Biggest Challenges of Field Service Delivery Field Service in the Cloud: Solving the 5 Biggest Challenges of Field Service Delivery The ServiceMax Whitepaper Executive Summary The time has come for field service organizations to also reap the benefits

More information

COTS Validation Post FDA & Other Regulations

COTS Validation Post FDA & Other Regulations COTS Validation Post FDA & Other Regulations TABLE OF CONTENTS 1. Abstract 3 2. What is COTS 3 3. Why should COTS require Validation? 3 4. Risk Based Approach 4 5. Validation Approach 6 6. Applicable Regulations

More information

Document and Quality Management Solutions for Life Sciences

Document and Quality Management Solutions for Life Sciences Document and Quality Management Solutions for Life Sciences Company Overview Global Provider Established US and European footprint Proven Solution SharePoint based document and quality management. Solutions

More information

Infor CloudSuite Industrial (SyteLine) for Medical Devices

Infor CloudSuite Industrial (SyteLine) for Medical Devices Medical Devices Infor CloudSuite Industrial (SyteLine) for Medical Devices Stay current with the shifting standards of FDA compliance For medical device manufacturers, advancing and maintaining information

More information

E-learning with the British Safety Council

E-learning with the British Safety Council E-learning with the British Safety Council Membership Training Qualifications Audit and Consultancy Policy and Opinion Awards About us For more than half a century we ve been a trusted guide to excellent

More information

A CobbleSoft Customer Solutions Case Study

A CobbleSoft Customer Solutions Case Study When you re the leader of the technology pack, how do you reassure customers that your controls and processes are in compliance with the highest of industry standards? A CobbleSoft Customer Solutions Case

More information

EZValidation Online Tool. The easy way to apply guidelines. The EZValidation Online Tool. The implementation of new tests

EZValidation Online Tool. The easy way to apply guidelines. The EZValidation Online Tool. The implementation of new tests The implementation of new tests The EZValidation Online Tool Since 999, AcroMetrix has provided quality control requires validation or verification studies that meet is a comprehensive tool specifically

More information

Standardizing Best Industry Practices

Standardizing Best Industry Practices MEDICAL DEVICES Current market conditions have created a highly competitive and challenging environment for the medical device industry. With stricter FDA regulatory oversight, increasing material costs

More information

Wonderware QI Analyst

Wonderware QI Analyst Invensys Software Datasheet Summary is now Wonderware QI Analyst Wonderware QI Analyst software provides a complete SPC software system, combining ease of use, powerful statistical techniques, real-time

More information

IBM esignature overview

IBM esignature overview IBM esignature overview Signing IBM Agreements using IBM esignature Sign your IBM Agreements using IBM esignature Signing contracts using electronic signatures eliminates the hassles of pen and paper and

More information

A Complete Drug Stability Program. Stability Lab Information Manager SL IM

A Complete Drug Stability Program. Stability Lab Information Manager SL IM A Complete Drug Stability Program Stability Lab Information Manager SL IM SLIM is a Fully Validated, World-Class Stability LIMS. SLIM combines the ease of use of browser style user interface and industry

More information

Environmental Management System & Compliance Suite. Web-based Environmental Software Boost your bottom line. Build a better world.

Environmental Management System & Compliance Suite. Web-based Environmental Software Boost your bottom line. Build a better world. Web-based Environmental Software Boost your bottom line. Build a better world. The Intelex Environmental Management System (EMS) is a 100% web-based, highly configurable solution that helps organizations

More information

IBM Cognos Express Essential BI and planning for midsize companies

IBM Cognos Express Essential BI and planning for midsize companies Data Sheet IBM Cognos Express Essential BI and planning for midsize companies Overview IBM Cognos Express is the first and only integrated business intelligence (BI) and planning solution purposebuilt

More information

Moving from Paper to Electronic Records: Hardwiring Compliance into Product Development Using technology to incorporate quality system regulation

Moving from Paper to Electronic Records: Hardwiring Compliance into Product Development Using technology to incorporate quality system regulation P T C. c o m White Paper Medical Devices Page 1 of 8 Moving from Paper to Electronic Records: Hardwiring Compliance into Product Development Using technology to incorporate quality system regulation Abstract

More information

ORACLE PROCESS MANUFACTURING QUALITY MANAGEMENT

ORACLE PROCESS MANUFACTURING QUALITY MANAGEMENT ORACLE PROCESS MANUFACTURING QUALITY MANAGEMENT KEY FEATURES Automated stability study management Lot expiration handling and retesting Potency or variability management Quality holds during receiving

More information

Summary of Requirements for ISO 14001:2004 February 24, 2005

Summary of Requirements for ISO 14001:2004 February 24, 2005 Summary of Requirements for ISO 14001:2004 February 24, 2005 This document provides a summary of the requirement of ISO 14001:2004, which is an international standard describing the specification and requirements

More information

Introducing the New FaciliWorks 8i

Introducing the New FaciliWorks 8i Introducing the New FaciliWorks 8i FaciliWorks 8i Enterprise Asset Management software is the highest quality web-based software product available for the facilities maintenance marketplace. Easy to implement,

More information

ORACLE AGILE PLM FOR THE MEDICAL DEVICE INDUSTRY

ORACLE AGILE PLM FOR THE MEDICAL DEVICE INDUSTRY ORACLE AGILE PLM FOR THE MEDICAL DEVICE INDUSTRY Enterprise PLM is a strategic approach to managing the lifecycle of a product throughout its full value chain: from initial requirements gathering through

More information

ORACLE QUALITY ORACLE DATA SHEET KEY FEATURES

ORACLE QUALITY ORACLE DATA SHEET KEY FEATURES ORACLE QUALITY KEY FEATURES Enterprise wide Quality Data Repository In-process Quality Integrated with manufacturing, logistics, maintenance and service modules in the Oracle E-Business Suite. Analysis

More information

Audit & Inspection Management. Enterprise Cloud Audit & Inspection Management Solution

Audit & Inspection Management. Enterprise Cloud Audit & Inspection Management Solution Enterprise Cloud Solution is an end-to-end solution for the planning, execution and reporting of corporate external and internal audit and inspections across enterprise risk, safety, security and sustainability.

More information

Building the Business Case for BPM Automation in Process Manufacturing

Building the Business Case for BPM Automation in Process Manufacturing Building the Business Case for BPM Automation in Process Manufacturing Business process management automation streamlines your enterprise, strengthens your ERP solution and dramatically lowers costs. If

More information

Vena 5 Overview. An Innovative Approach to Corporate Performance Management

Vena 5 Overview. An Innovative Approach to Corporate Performance Management Embrace, Don t replace your spreadsheets Vena 5 Overview An Innovative Approach to Corporate Performance Management Vena 5 is an easy-to-use and rapidly deployed solution for budgeting, planning, forecasting,

More information

4 Elements of an Effective Food Safety Management System. How to meet your changing challenges and ensure success.

4 Elements of an Effective Food Safety Management System. How to meet your changing challenges and ensure success. 4 Elements of an Effective Food Safety Management System How to meet your changing challenges and ensure success. Safety is everything Food and Beverage manufacturers face a range of pressures: increasingly

More information

OECD DRAFT ADVISORY DOCUMENT 16 1 THE APPLICATION OF GLP PRINCIPLES TO COMPUTERISED SYSTEMS FOREWARD

OECD DRAFT ADVISORY DOCUMENT 16 1 THE APPLICATION OF GLP PRINCIPLES TO COMPUTERISED SYSTEMS FOREWARD OECD DRAFT ADVISORY DOCUMENT 16 1 THE APPLICATION OF GLP PRINCIPLES TO COMPUTERISED SYSTEMS FOREWARD 1. The following draft Advisory Document will replace the 1995 OECD GLP Consensus Document number 10

More information

Document Management Server - Overview

Document Management Server - Overview Introduction The Document Management System (DMS) is a web-based application designed to allow for storage and retrieval of documents with user-defined document types, document groups, and keywords. The

More information

How to implement a Quality Management System

How to implement a Quality Management System How to implement a Quality Management System This whitepaper will help you to implement a Quality Management System (QMS), based on Good Manufacturing Practice (GMP), ISO 9001 or ISO 13485 within your

More information

Imperative. Tim Mohn Industry Principal Sparta Systems

Imperative. Tim Mohn Industry Principal Sparta Systems Enterprise Level ChangeControl: Control: A Life Science Business Imperative Tim Mohn Industry Principal Sparta Systems Agenda GlobalChange Control: An Overview Benefits and Challenges Change Control as

More information

Profit. Enterprise Risk and Compliance Management. Effective Risk & RCM and Three P s. Ed Sattar, CEO, 360factors inc.

Profit. Enterprise Risk and Compliance Management. Effective Risk & RCM and Three P s. Ed Sattar, CEO, 360factors inc. Enterprise Risk and Compliance Working in Compliance vs. Working On Compliance Ed Sattar, CEO, 360factors inc. Effective Risk & RCM and Three P s Profit Planet People Page 2 1 Outline Regulatory & Operational

More information

Quality Agreement Template

Quality Agreement Template Quality Agreement Template Prepared by Dan O Leary Ombu Enterprises, LLC 3 Forest Ave. Swanzey, NH 03446 603-209-0600 This document is intended to form the basis for a Supplier Agreement. The document

More information

LanguageDesk is the web-based project management tool from Milengo that takes the hassle out of managing translation projects.

LanguageDesk is the web-based project management tool from Milengo that takes the hassle out of managing translation projects. 4 LanguageDesk Cloud-based translation LanguageDesk is the web-based project management tool from Milengo that takes the hassle out of managing translation projects. BENEFITS 24/7 availability Intuitive

More information

Digital Asset Management

Digital Asset Management A collaborative digital asset management system for marketing organizations that improves performance, saves time and reduces costs. MarketingPilot provides powerful digital asset management software for

More information

Validating Enterprise Systems: A Practical Guide

Validating Enterprise Systems: A Practical Guide Table of Contents Validating Enterprise Systems: A Practical Guide Foreword 1 Introduction The Need for Guidance on Compliant Enterprise Systems What is an Enterprise System The Need to Validate Enterprise

More information

INTEGRATED MANAGEMENT SYSTEM MANUAL IMS. Based on ISO 9001:2008 and ISO 14001:2004 Standards

INTEGRATED MANAGEMENT SYSTEM MANUAL IMS. Based on ISO 9001:2008 and ISO 14001:2004 Standards INTEGRATED MANAGEMENT SYSTEM MANUAL IMS Based on ISO 9001:2008 and ISO 14001:2004 Standards Approved by Robert Melani Issue Date 30 December 2009 Issued To Management Representative Controlled Y N Copy

More information

epcr QUALITY MANAGEMENT PERSONNEL MANAGEMENT QUICK SPEAK FIRE

epcr QUALITY MANAGEMENT PERSONNEL MANAGEMENT QUICK SPEAK FIRE SOFTWARE SUITE epcr QUALITY MANAGEMENT PERSONNEL MANAGEMENT QUICK SPEAK FIRE Free software upgrades & technical lifetime support. ESO Software is accessible from any computer and offers: A NEMSIS Gold

More information

PERSONAL INJURY LAW PRACTICE AREA TEMPLATE for Time Matters /Total Practice Advantage

PERSONAL INJURY LAW PRACTICE AREA TEMPLATE for Time Matters /Total Practice Advantage PERSONAL INJURY LAW PRACTICE AREA TEMPLATE for Time Matters /Total Practice Advantage By IP ASSOCIATES, LLC Why do you need a Practice Template? Tired of using the one size fits all setup that shipped

More information

Web Security Monitor. I R O N P O R T S - S E R I E S F e a t u r e Overview

Web Security Monitor. I R O N P O R T S - S E R I E S F e a t u r e Overview I R O N P O R T S - S E R I E S F e a t u r e Overview I r o n P o r t Web Security Monitor I n s ta n t ly a s s e s s a n d p r o t e c t a g a i n s t a r a n g e o f W e b s e c u r i t y t h r e at

More information

The Pension Portal. Helping you take your pension business into the paperless age

The Pension Portal. Helping you take your pension business into the paperless age The Pension Portal Helping you take your pension business into the paperless age When you ve been helping pension professionals implement client portals for as long as we have, you understand that the

More information

IT Service Continuity Management PinkVERIFY

IT Service Continuity Management PinkVERIFY -11-G-001 General Criteria Does the tool use ITIL 2011 Edition process terms and align to ITIL 2011 Edition workflows and process integrations? -11-G-002 Does the tool have security controls in place to

More information

Software Verification and Validation

Software Verification and Validation Software Verification and Validation Georgia L. Harris Carol Hockert NIST Office of Weights and Measures 1 Learning Objectives After this session, using resources and references provided, you will be able

More information

Organization Profile. IT Services

Organization Profile. IT Services Introduction In today s scientific and medical world, various issues in clinical trials and research have permeated every society and every field in medicine. Ethics and in particular the quality of research

More information

Empowering Global Medical Information Teams with Software Solutions

Empowering Global Medical Information Teams with Software Solutions www.arisglobal.com A White Paper Presented By ArisGlobal Empowering Global Medical Information Teams with Software Solutions by Ome Ogbru, PharmD, Medical Information, SME Empowering Global Medical Information

More information

Information Document

Information Document Information Document Genial Compliance Systems Rainbow Scientific Inc P.O. Box 3751, Chester, CH1 9UF, United Kingdom 83 Maple Avenue, Windsor, CT 06095 Telephone & Fax: +44 (0)1244 757155 Tel: 860-298-8382

More information

IBM Cognos Express. Breakthrough BI and planning for midsize companies. Overview

IBM Cognos Express. Breakthrough BI and planning for midsize companies. Overview IBM Cognos Express Breakthrough BI and planning for midsize companies Overview IBM Cognos Express is the first and only integrated business intelligence (BI) and planning solution purpose-built to meet

More information

Task Management. JobTraQ Core Features

Task Management. JobTraQ Core Features Task Management JobTraQ automates human to human workflow and simplifies hierarchical team management of collaborative tasks. JobTraQ also ensures that the correct data is collected and displayed through

More information

A multi-purpose and multi-network compliance management software package

A multi-purpose and multi-network compliance management software package A multi-purpose and multi-network compliance management software package Product Overview All aspects - from installation to implementation to deployment - are designed to be simple and easy, yet extremely

More information

(Discover) financial solutions for your campus

(Discover) financial solutions for your campus (Discover) financial solutions for your campus WHO WE ARE One element of our shared course for success is to improve and empower higher education through choice from giving students and their families

More information

21 CFR Part 11 Compliance Using STATISTICA

21 CFR Part 11 Compliance Using STATISTICA 21 CFR Part 11 Compliance Using STATISTICA Last Updated: April 2003 This document was updated to reflect the FDA s latest guidance (released February, 2003) and the withdrawal of previous guidance.! STATSOFT

More information

Quality Enhancement Unit Environmental Management System Module 6. Document Control

Quality Enhancement Unit Environmental Management System Module 6. Document Control Quality Enhancement Unit Environmental Management System Module 6 Document Control Module 6 Objectives What is EMS Documentation? What are Documents and Records? ISO 14001 Requirements for Documents NCDOT

More information

Establishing regulatory compliance in the medical device industry

Establishing regulatory compliance in the medical device industry Siemens PLM Software Establishing regulatory compliance in the medical device industry www.siemens.com/plm w h i t e p a p e r To help medical device companies better understand the requirements associated

More information

CASE STUDY: CHANNEL PARTNERS LLC. ASPIRE helps Channel Partners LLC expand its on-balance sheet lending from a flexible end-to-end platform.

CASE STUDY: CHANNEL PARTNERS LLC. ASPIRE helps Channel Partners LLC expand its on-balance sheet lending from a flexible end-to-end platform. CASE STUDY: CHANNEL PARTNERS LLC ASPIRE helps Channel Partners LLC expand its on-balance sheet lending from a flexible end-to-end platform. Overview Channel Partners LLC ( Channel Partners ) was founded

More information

Your document control procedure should address responsibility and authority for:

Your document control procedure should address responsibility and authority for: DOCUMENT CONTROL Background and Exhibits To ensure that personnel are consistently performing their jobs in the right way, the facility must provide them with the proper tools. In the context of an EMS,

More information

Brochure. ECM without borders. HP Enterprise Content Management (ECM)

Brochure. ECM without borders. HP Enterprise Content Management (ECM) Brochure ECM without borders HP Enterprise Content Management (ECM) HP Enterprise Content Management (ECM) Without question, the volume, variety, and velocity of data across your enterprise create new

More information

White Paper. The Five Keys to a Successful Document Management System ABSTRACT. www.treenosoftware.com Command Your Content

White Paper. The Five Keys to a Successful Document Management System ABSTRACT. www.treenosoftware.com Command Your Content 1 White Paper The Five Keys to a Successful Document Management System ABSTRACT The successful implementation of an electronic document management system begins with a detailed understanding the specific

More information

Introducing the New FaciliWorks 8i

Introducing the New FaciliWorks 8i Introducing the New FaciliWorks 8i FaciliWorks 8i Enterprise Asset Management software is the highest quality web-based software product available for the facilities maintenance marketplace. Easy to implement,

More information

Track-It! 8.5. The World s Most Widely Installed Help Desk and Asset Management Solution

Track-It! 8.5. The World s Most Widely Installed Help Desk and Asset Management Solution The World s Most Widely Installed Help Desk and Asset Management Solution Key Benefits Easy to use! Gain full control of your IT assets, hardware and software Simplify software license management Save

More information

D o n o r R e l a t i o n s h i p M a n a g e m e n t S o f t w a r e, C a m p a i g n M a n a g e m e n t, R e p o r t i n g & A n a l y t i c s

D o n o r R e l a t i o n s h i p M a n a g e m e n t S o f t w a r e, C a m p a i g n M a n a g e m e n t, R e p o r t i n g & A n a l y t i c s Comprehensive Data Management Solutions for Nonprofit Organizations D o n o r R e l a t i o n s h i p M a n a g e m e n t S o f t w a r e, C a m p a i g n M a n a g e m e n t, R e p o r t i n g & A n a

More information

TotalChrom. Chromatography Data Systems. Streamlining your laboratory workflow

TotalChrom. Chromatography Data Systems. Streamlining your laboratory workflow TotalChrom Chromatography Data Systems Streamlining your laboratory workflow maximize productivity with TotalChrom CDS Acquiring, processing, reporting, reviewing and approving data is a streamlined series

More information

Validating Methods using Waters Empower TM 2 Method. Validation. Manager

Validating Methods using Waters Empower TM 2 Method. Validation. Manager Validating Methods using Waters Empower TM 2 Method Validation Manager (MVM) Anders Janesten Nordic Informatics Sales Specialist 2008 Waters Corporation Decision-centric centric method development information

More information

Comindware Tracker. Reviewer s Guide. 2012 Comindware Inc.

Comindware Tracker. Reviewer s Guide. 2012 Comindware Inc. Comindware Tracker Reviewer s Guide 2012 Comindware Inc. 1 Dear Editor, We appreciate that you decided to try Comindware Tracker and write a review about it. We would like to make it easier for you and

More information

Is your Contract Management just Good Enough?

Is your Contract Management just Good Enough? Is your Contract Management just Good Enough? Table of Contents 1.0 Introduction...3 2.0 What Contract Management Issues Do Enterprises Face?...4 2.1 Revenue Assurance... 4 2.2 Risk Management... 5 2.3

More information

Service-Oriented Cloud Automation. White Paper

Service-Oriented Cloud Automation. White Paper Service-Oriented Cloud Automation Executive Summary A service-oriented experience starts with an intuitive selfservice IT storefront that enforces process standards while delivering ease and empowerment

More information

Service Portfolio Management PinkVERIFY

Service Portfolio Management PinkVERIFY -11-G-001 General Criteria Does the tool use ITIL 2011 Edition process terms and align to ITIL 2011 Edition workflows and process integrations? -11-G-002 Does the tool have security controls in place to

More information

Audit & Inspection Management. Enterprise Cloud Audit & Inspection Management Solution

Audit & Inspection Management. Enterprise Cloud Audit & Inspection Management Solution Enterprise Cloud Solution is an end-to-end solution for the planning, execution and reporting of corporate external and internal audit and inspections across enterprise risk, safety, security and sustainability.

More information

Appendix M. Change Management QUESTIONS

Appendix M. Change Management QUESTIONS Appendix M Change Management Change management is the process by which changes are introduced into the information technology (IT) environment. The change management process facilitates the migration of

More information

IBM asset management solutions White paper. Managing corrective and preventive action (CAPA) in a life sciences environment.

IBM asset management solutions White paper. Managing corrective and preventive action (CAPA) in a life sciences environment. IBM asset management solutions White paper Managing corrective and preventive action (CAPA) in a life sciences environment. March 2007 Page 2 Contents 2 Executive summary 4 Setting the stage 5 When is

More information