Control in an automated environment
|
|
- Karin Briggs
- 5 years ago
- Views:
Transcription
1 WHITEPAPER Managing Your Medical Device Master Files and Records Control in an automated environment Introduction In today s age of Globalization and cut-throat competition, it has become competitive necessity for Manufacturers to leverage teams that located across geographies you may have your design team in the US, your engineering team in India, your manufacturing team in China, and quality team in Germany. With such a geographically dispersed team, with each creating and storing their own set of files with different information, it has become increasingly difficult to find right information at the right time. On the other hand, increased regulatory pressure, especially on regulated industries, 01
2 has mandated organizations to ensure compliance with a set of standards or regulations key to which is having well documented, objective evidence. This means organizations must have the ability to access all key data elements that are captured within different processes and link them not only to particular documents but also to specific and relevant sections within those documents. A proper compliance control and document management system, thus, needs to provide the compliance department of any organization with the required system of evidence that is necessary for audit defense. At first thought, it might appear that most organizations in regulated industries would have functional document management systems that should be able to do this. The reality, however, is far from this. Compliance document management often remains highly silo-ed and fragmented, with most organizations not knowing what documents exist within their walls and/or where they are stored. Complications exist in this process in many forms. Manufacturing and medical devices companies, for example, have numerous drawings, notes, papers, and collaborative pieces created during the design process. Audits that may come years down the line may need you to access some of these documents. What are the chances of retrieval of such documents and any related information quickly especially if you have volumes in a paper based system? Not a lot! Medical device manufacturers make use of some of the most advanced technology of the day to make devices that work with magical precision, in comparison the systems used for managing documentation seem a bit antiquated. Many of them cling to paper and manual ways of documentation, often citing the fear of violations arising from any change to existing ways of working. However, in the process, they end up causing significant productivity losses and introduce other inefficiencies into their business. When audits happen, they have to dig into stacks of manual binders to retrieve the information that is being asked for by the auditor. The more the delay and difficulties in retrieval of this information, the lesser is the auditor s confidence in the business. This can end up lengthening the auditor s list of requests. Challenges in manual record keeping Having a paper based system of document management creates more problems for the organization than it solves, and the number of problems go on increasing longer the document needs to be stored and accessed. A new product, in medical device manufacturing, for example, can take anywhere between 1 year and 5 years to develop. It is important for the manufacturer to maintain the various files associated with product development like Design History File (DHF), Design Master Record (DMR) and Device History Record (DHR), among many other critical documents. These documents need to be accessed by the product engineers and manufacturing for their internal use as well as it is imperative to have them in proper order and readily available for external audits. Difficult to get the right information at the right time The sheer volumes of documents created over the product development period makes it very difficult to track all of them over lab notebooks, internal memos, s, and documents stored at various physical locations. Paper based systems create huge inefficiencies in the process as they make it difficult to find the right information quickly. It becomes very difficult to maintain the different versions of the same document. It is important that everyone works on the latest version of the document with all the edits and reviews incorporated. The paper based document management system also creates storage and safety issues in the office. 02
3 Lack of smooth flow of information between Engineering and Production In today s world where speed-to-market is one of the highest priorities for top Executives, a perfectly harmonized flow of information between Engineering and Production (or Manufacturing) is a must for a successful product launch. A master document captures this information in the form of product specifications, and Production must, at all times, have access to latest version of it. As product specifications can go through a lot of changes, a lack of control for these Master documents can cause issues in production. If Engineering and Production are not looking at the same version of the Master document, or if Engineering does not capture changes to product specifications in the correct version, there will exist an information gap between design engineering and manufacturing teams. In a manufacturing process this could cause catastrophic failures when the product is released for production such as faulty design, deviations in manufacturing and clinical processes, inconsistent raw materials and parts etc. It is very important that the production and quality teams are able to share and collaborate on all the product related documents to ensure the product is a success, and to avoid product defects which, if found too late, can be costly such as resulting in recalls. Delays in internal reviews and approvals The product reviews in the manufacturing industry, especially in regulated fields like medical devices, are very stringent. Each of the document needs to signed and approved and only then the team can move to next phase. In a paper based environment it becomes a nightmare just to collect all the documents like design history file, design master record, device history record etc. at the same place. The information may be stored in too many different pieces, in too many different locations and in too many different versions. The team needs to collect and consolidate all the documents and then ensure that all these documents contain all the relevant and needed information. Each of these documents then needs to be sent for approvals to multiple top executives. Multiple follow-ups are done to get all the approvals which are finally recorded and saved. This entire process causes a lot of delay in the review process. Noncompliance in external audits Manufacturing firms have to undergo different types of external audits like ISO or U.S. Food and Drug Administration (FDA). It is imperative for the firm to always be ready for an audit. When an audit happens the inspector can ask for any file or document related to the design and development of any of the products of the firm. It becomes very difficult to find the right file when needed and it becomes even worse when the file has some information or approvals missing. The product development might sometime take over five years and this makes it even more difficult to provide old files for the audit. The challenge is even greater for the companies operating in multiple countries. Different regions across the globe have different regulators, each with their own requirements and specifications. The FDA s design control requirements in the US are significantly different from the technical dossier required to obtain a CE Mark in Europe and Shonin (pre-market approval) in Japan. For both Europe and Japan, regulatory requirements and audits are based on ISO standards. Hence the manufacturer needs to maintain different files for satisfying different audit requirements for different regulators. Difficult to make post market changes After a product gets all the approvals and is finally launched in the market all its related documents are stored in a document control 03
4 room, but the lifecycle of the product documents does not end with the product launch. A product undergoes multiple changes and iterations over its lifetime. There may be some complaints or nonconformance that would necessitate a change in the product. There will be corrective and preventive actions (CAPA) for improving the product. There may be another version launched with more functions and improvements. For each of these iterations the team will have to go back to the original design documents. In case the team involved in the original design is no longer there it becomes all the more difficult to find the relevant design and development documents for the product as the new team is not aware of what documents to look for. Hence, every time a change is needed in the product, a lot of time a nd resources are wasted in finding the right documents, making the changes and then refiling them. Due to all the above challenges, the Manufacturers today have realized that a paper based system will not suffice in an environment where products are becoming increasingly complex and audit requirements are getting more and more stringent. They have realized the importance of consolidation of all files making up a Master Record to be in one place, so that when a change does take place, anybody using the Master document will have the latest version. And that is the key value proposition of an Electronic Binder. Keeping the Master Record together As teams collaborate across geographies, and as the world itself becomes increasingly digital, the importance leveraging digital tools and platforms for managing large amounts of information in a logical and efficient manner, cannot be emphasized enough. And especially regulated industries, such as medical device and equipment manufacturing, can t afford aversion to digital information management. Let us take the example of documenting the design and development of a medical device. The complete documentation of this development is referred to as the Design History File (DHF). FDA requires you to give it to them as a proof that you have followed all the prescribed design control regulations. It is a must to clear all audits. As a central hub for compliance in the design process, DHF allows you traceability of all design controls and shows the relationships and linkages between the various design controls. Using digital means of information management, such as an Electronic Binder, for managing DHF gives you multiple benefits like having complete revision control, automating the routing of documents in a secure manner and having complete audit trails. Electronic Binders Quick access to any document Quickly add documents in various formats, including web content Connect documents with each other View and search documents Support for scanning paper based documents directly into the binder Rearrange the documents on the go Make better sense of data by adding notes, underlining, highlighting, etc. Better version control of documents Reduced cycle time for design completion Complete and accurate audit trail Automated CR management And much more! Electronic binders are collections of electronic documents. One electronic document can exist in multiple binders. You can create private binders as well as share them with designated team members. They allow multiple people access across geographic locations and also allow you to 04
5 quickly change who has access and what permissions they have. Unlike physical binders, there is no fear of any confidentiality breaches occurring due to the binders getting left somewhere or falling into the wrong hands since there are enough security features built in. Electronic binders serve to keep together master data files and information from multiple documents, much like traditional ring binders help store and organize paper documents. They help maintain all the relevant information with the latest version of the source documents. They also allow for collaboration, for example, between employees focused on different areas of a master file. Needless to say, not only do the Electronic Binders save you time and money (in terms of print, paper, and postage cost), they also increase productivity and improve communication among the different stakeholders. system is its inability to trace a problem for a particular product back to its source. In today s age of distributed manufacturing, records are highly relational and often comprise of a whole bunch of associated data and files it can be a paper nightmare taking hours, days or sometimes weeks to figure out at which stage of the product lifecycle did the error creep into the final design. Heightened regulatory requirements further necessitate organizations to maintain a properly tracked link between all design reworks, components, illustrations etc. within the Device Master Records and Design History Files for each product. This integration is nigh impossible to achieve with Document Control systems based on spreadsheets, network folders, or paper based systems. Electronic binders are not restricted to any one particular stage of the product life cycle. They can be used across the life cycle and help maintain a complete audit trail of what happened to the product based on the control of master document/files throughout the product development process of the medical devices. Now, who wouldn t like that! Integration with other downstream processes Paper based documents typically do not include all vital information, and typically will not take into account items such as nonconformances, actions taken against a SCAR (Supplier Corrective Action Requests), corrective and preventive actions (CAPAs), complaints, etc., thereby limiting their efficacy for downstream processes, such as the Quality Management processes. Another challenge with a paper based 05
6 Benefits of connecting Quality Data with Document Control Connecting Quality data with Master Files not only facilitates easier search and traceability, but also the identification of the root cause of issues. In a paper based environment, a change requested in the design/specification of a device often results in a complex Change Management process, which in itself is often a manual and time-consuming process that needs to be documented in an altogether different system often de-coupled from the actual product. If a mistake is made in managing this Change Request, thus resulting in an error in the final product design, it will be very difficult to pin-point this error by looking at the product history alone. Most Electronic Binders support a feature to electronically rout Change Requests to relevant product, and record the trail for this change. This not only provides an accurate trace back to a specific Change Request, thereby pin-pointing the root cause, but also helps in greatly reducing the Change Management cycle time. In order to obtain an FDA approval, manufacturers of Medical Devices need to maintain a record of all changes made to the design of the said device. These changes must then be made available to various stakeholder, including operations teams, design partners, quality teams, outsourcing vendors, and material suppliers in real-time to ensure one single version of the truth. While everyone remembers to get proper approval from a competent authority on these changes, ensuring that changes are well documented, validated, and maintained for traceability is where slip ups often happen standalone, spreadsheet based trackers can just not accomplish this task. An automated system will not only can significantly transform the operations by reducing time taken for conducting internal and external audits, decreasing risk of product recalls, improving product quality and safety, and thereby ensuring FDA and ISO compliance. Conclusion As with any other organization, prime focus of the manufacturers of Medical Devices should be on developing the core competencies, and that is where the day-today operations should concentrate their efforts. Inefficient and ineffective paper master files and records not only drain resources from critical operational activities to cope with the pains of managing mountain load of files, but they also jeopardize the reputation, and even existence, of the organizations by putting at risk the capability to meet with compliance requirements. The ultimate goal of the Document Control department should be to ensure that the master files and records are accurate, current, and easy to maintain, while the internal dynamics of maintaining the trail of document change should be better left to an automated system, such as an electronic binder which will not only result in reduced time to find information and a better traceability, but can also enable anytime, anywhere access to information, and can greatly simplify audit defense to regulatory inspector. Electronic documentation has been in existence for many years now and even FDA guidelines for the same have been in existence for over two decades. Today s Document Management tools have come a long way from the early word processing tools that came in existence with the advent of personal computers in the late 1980s. In the last 30 years, these tools have become much more powerful offering many features like versioning, automated reporting, traceability etc. The technology available in the market for electronic documentation and retrieval has thus evolved highly over the years. It is high time medical device 06
7 manufacturers evolve too, and embrace the electronic ways of controlling documentation. About the Author Govardhan Muralidhar brings more than 15 years of extensive experience in the design, development and deployment of enterprise quality and compliance management solutions across manufacturing, life sciences and regulated industries. He has worked with over 200 clients for the deployment of either on-premise or cloud based QMS solutions. Gova is currently a passionate Customer Success Ambassador at ComplianceQuest, the leading EQMS solution on the Salesforce platform. About ComplianceQuest The vision at ComplianceQuest is to transform quality and compliance into a strategic advantage for our customers through experience, expertise and passion. ComplianceQuest is an innovative, 100% cloud based Enterprise Quality Management System solution company. We provide an enterprise grade solution that streamlines quality, compliance, content and collaboration management initiatives and strategies across diverse, globally based supply chain networks. For more information, or to request a demo with a ComplianceQuest expert, contact ComplianceQuest today. Visit us at info@compliancequest.com Call us at ComplianceQuest LLC 07
Four Best Practices To Improve Quality In the Supply Chain. Lower supply chain risks and cost of quality
Four Best Practices To Improve Quality In the Supply Chain Lower supply chain risks and cost of quality 1 Table of Contents 3 Introduction 7 Quality Risks in the Supply Chain 10 The Big Challenge 16 Best
More informationThe 5 Building Blocks of a CAPA Solution. Managing Corrective Actions/Preventive Actions for the Consumer Products Industry
The 5 Building Blocks of a CAPA Solution Managing Corrective Actions/Preventive Actions for the Consumer Products Industry 1 Table of Contents 3 Introduction 5 Tackling Quality Issues & Incidents 8 Five
More informationEmbracing The Digital Evolution For Content Management - Your online source for medical device product information
mpo-mag.com Embracing The Digital Evolution For Content Management - Your online source for medical device product information 9-11 minutes Terri Howard, Director of Commercial Strategy, Medical Device
More informationInfor CloudSuite Industrial
Infor CloudSuite Industrial Stay current with the shifting standards of FDA compliance For medical device manufacturers, advancing and maintaining information management solutions that are compliant with
More informationTech-Clarity Insight: Integrating PLM and MES. Realizing the Digital Factory
Tech-Clarity Insight: Integrating PLM and MES Realizing the Digital Factory Tech-Clarity, Inc. 2011 Table of Contents Executive Overview... 3 Why Now?... 4 Product Innovation and Execution Roles... 5 Integrating
More informationDigitizing Complex Discrete Manufacturing Processes
GE Intelligent Platforms Digitizing Complex Discrete Manufacturing Processes Driving lower costs, higher quality and faster production to stay competitive today and ensure success tomorrow Introduction
More informationReducing Risks and Reaping Rewards
a consumer goods technology whitepaper Reducing Risks and How an Enterprise Quality Management Solution Benefits PRODUCED BY As food markets become more global, the risk of compromise to food safety increases,
More informationSecure, Efficient Content and Submission Lifecycle Management. QUMAS R&D Solution TM
Secure, Efficient Content and Submission Lifecycle Management QUMAS R&D Solution TM R&D Strategy Out of the Box R&D Strategy Out of the Box In an industry shaped by ever-increasing regulation, global competition
More informationEQMS Coexistence in an Enterprise Environment. Best Practices to Managing Quality Processes
EQMS Coexistence in an Enterprise Environment Best Practices to Managing Quality Processes 1Introduction IT System 3 Quality System Processes Benefits of EQMS 5Resources Introduction Organizations have
More informationMDM offers healthcare organizations an agile, affordable solution To deliver high quality patient care and better outcomes
MDM offers healthcare organizations an agile, affordable solution To deliver high quality patient care and better outcomes Many healthcare organizations are struggling with rising costs and inconsistent
More informationENTERPRISE LABELING FOR THE MEDICAL DEVICE INDUSTRY STAY COMPLIANT WHILE IMPROVING SUPPLY CHAIN OPERATIONS
ENTERPRISE LABELING FOR THE MEDICAL DEVICE INDUSTRY STAY COMPLIANT WHILE IMPROVING SUPPLY CHAIN OPERATIONS 1 IT S TIME FOR POWERFUL NEW SOLUTIONS IN MEDICAL DEVICE LABELING For medical device manufacturers,
More informationWindchill Quality Management
Windchill Quality Management Closed-Loop Quality for Medical Device Innovators Windchill Quality Management is purpose-built for medical device makers who seek to accelerate delivery of breakthrough medical
More informationCase Study. Flexibility and Audit-Readiness Give Compounding Companies a Competitive Advantage
Flexibility and Audit-Readiness Give Compounding Companies a Competitive Advantage Flexibility and Audit-Readiness Give Compounding Companies a Competitive Advantage Since opening its doors in Quebec in
More informationThe Age of Agile Solutions
>> Whitepaper The Age of Agile Solutions Creating Interconnected Ecosystems October 2017 Sell Side Sponsored by The Age of Agile Solutions Contents Executive Summary... Technology and Services to Unlock
More informationIntro & Executive Summary
How do you encourage future growth and profitability with outdated systems and processes? The answer lies in Enterprise Resource Planning (ERP). A strong ERP system will not only guide you through your
More informationLabeling Best Practice in a Challenging Manufacturing Landscape A survival guide for pharmaceutical companies
Labeling Best Practice in a Challenging Manufacturing Landscape A survival guide for pharmaceutical companies White Paper www.nicelabel.com/pharma 1 1 Executive summary The number of challenges for the
More informationHOW TO REDUCE COMPLIANCE RISK IN PACKAGING & LABELING
GUIDE HOW TO REDUCE COMPLIANCE RISK IN PACKAGING & LABELING Master Sample Contents Global Vision Systems 03 Where are manual inspection processes used? 04 Regulatory 04 Labeling 05 Manufacturing 06 The
More informationTransforming Change Management with Modern Systems
Transforming Change Management with Modern Systems Mike Jovanis, VP Vault Quality Abstract Transforming Change Management with Modern Systems Assessing impact, and creating and executing a change plan
More informationHow Next Generation Electronic Quality Management Systems Equip Medical Device Companies to Handle FDA s New Approach to Quality Regulations
WHITEPAPER How Next Generation Electronic Quality Management Systems Equip Medical Device Companies to Handle FDA s New Approach to Quality Regulations Introduction Compliance managers at prominent medical
More informationTech-Clarity Insight: Quality Risk Management in Life Sciences. Preventing Failures, Protecting Patient Health
Tech-Clarity Insight: Quality Risk Management in Life Sciences Preventing Failures, Protecting Patient Health Tech-Clarity, Inc. 2010 Table of Contents Table of Contents... 2 Executive Overview... 3 Mitigating
More informationTAKING CONTROL with MultiTRANS TM Translation Mangement System
TAKING CONTROL with MultiTRANS TM Translation Mangement System IT IS TIME TO TAKE CONTROL As big data grows even bigger, a power shift is happening in the world of translation management. Thanks to new
More information6 Steps to Effective Supplier Quality Audits. A Guide For Medical Device Companies
6 Steps to Effective Supplier Quality Audits A Guide For Medical Device Companies 1 Table of Contents 3 Why Supplier Quality Audits Matter 4 Manual vs. Automated Supplier Audits 5 Six Steps to Effective
More information9 Questions Food and Beverage Manufacturers Need to Ask About Their ERP
9 Questions Food and Beverage Manufacturers Need to Ask About Their ERP At a Glance: Food and beverage manufacturers need modern ERP systems that reduce the burden on their limited IT staff. Often the
More informationExperience what an integrated PLM and ERP system can do
PRODUCT LIFECYCLE MANAGEMENT Experience what an integrated PLM and ERP system can do For discrete manufacturers, having a product lifecycle management (PLM) solution that can seamlessly integrate with
More informationMICROSOFT DYNAMICS NAV FOR INTERNATIONAL
WHITEPAPER MICROSOFT DYNAMICS NAV FOR INTERNATIONAL IMPLEMENTATIONS MICROSOFT DYNAMICS NAV AND INTERNATIONAL ERP IMPLEMENTATION This whitepaper explains why Microsoft Dynamics NAV is particularly well-suited
More information5 Best Practices to Enhance Supplier Quality Management. Improve Visibility within the Supplier Network
5 Best Practices to Enhance Quality Management Improve Visibility within the Network 1 3 Introduction 4 Operational Trends 6 Impact and Consequences 7 Five Best Practices to Reduce Management Complexity
More informationBy Merit Solutions August, 2015
By Merit Solutions August, 2015 Introduction... 3 ERP Systems and the Tower of Babel... 3 Resisting ERP Change: Is It Actually Costing You?... 5 Don t Put Off an ERP Upgrade... 7 Conclusion... 9 About
More informationCARDIOVASCULAR DEVICE MANUFACTURER
CUSTOMER CASE STUDY CARDIOVASCULAR DEVICE MANUFACTURER Moving from Paper Processes to an Automated Enterprise Quality and Compliance System CARDIOVASCULAR DEVICE MANUFACTURER Moving from Paper Processes
More informationMedical Devices. Epicor for. Functionality. Meeting the Challenges for Medical Devices
Epicor for Medical Devices Functionality XXGlobal operations XXTraceability and quality XXCost management XXRapid configuration XXProduct lifecycle management XXRegulatory compliance XXFDA, cgmp, ISO,
More informationGE Digital Executive Brief. Enhance your ability to produce the right goods in time to satisfy customer demand
Enhance your ability to produce the right goods in time to satisfy customer demand Traditionally, successful production has relied heavily on skilled personnel. Experienced employees installed equipment
More informationISO FDA QSR. ISO and FDA QSR: A Step by Step Guide to Complying with Medical Device QMS Requirements
ISO 13485 FDA QSR ISO 13485 and FDA QSR: A Step by Step Guide to Complying with Medical Device QMS Requirements Jon Speer Founder & VP of QA/RA greenlight.guru Table of Contents 1 Introduction 4 QMS Philosophy
More informationTaking Control of Open Source Software in Your Organization
Taking Control of Open Source Software in Your Organization For IT Development Executives Looking to Accelerate Developer Use of Open Source Software (OSS) as part of a Multi-source Development Process
More informationAchieving CAD Interoperability in Global Product Design Environments. by Howie Markson SpaceClaim Corporation
Achieving CAD Interoperability in Global Product Design Environments by Howie Markson SpaceClaim Corporation Introduction Globalization in the manufacturing sector is increasing the need for more effective
More informationWhy Projects Fail and What Executives Can Do About It. The Truth About Requirements Definition and Management
Why Projects Fail and What Executives Can Do About It The Truth About Requirements Definition and Management White Paper May 2008 Contents Executive summary.................................................................3
More informationSolidWorks Enterprise PDM for Medical Device Manufacturers
t e c h n i c a l p a p e r SolidWorks Enterprise PDM for Medical Device Manufacturers Compliance with FDA 21 CFR Part 11 Extend the Value of SolidWorks with SolidWorks Enterprise PDM It is clear that
More informationCAPA Management: Best Practices and FDA QSR Mandate WHITE PAPER. ComplianceQuest In-Depth Analysis and Review
CAPA Management: Best Practices and FDA QSR Mandate WHITE PAPER ComplianceQuest In-Depth Analysis and Review CAPA Management: Best Practices and FDA QSR Mandate Establishing a corrective and preventive
More informationCENTRAL PROCESS REPOSITORY
CENTRAL PROCESS REPOSITORY IMPRIVA Inc. 101A Clay St. #196 San Francisco, CA 94111 877.838.9714 www.impriva.com U Over a seven week period, IMPRIVA identified and discussed the most common business process
More informationWHAT IS CAPA & WHY YOU NEED IT
WHAT IS CAPA & WHY YOU NEED IT To understand how to achieve greater quality in manufacturing, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management,
More informationDeltek Costpoint Manufacturing Solutions
Deltek Costpoint Manufacturing Solutions Leverage the industry s proven solution made for government contractors to help modernize operations and lower costs. Meeting Your Needs Today, and for the Future
More informationI D C T E C H N O L O G Y S P O T L I G H T
I D C T E C H N O L O G Y S P O T L I G H T C o n t r o l B u s iness Data Risks through End User D a t a P r o t ection and Governance February 2017 Adapted from Increasingly Complex Regulatory Environment
More informationPDM Buyer s Guide. Ensuring Maximum Value from Product Data Management
PDM Buyer s Guide Ensuring Maximum Value from Product Data Management Tech-Clarity, Inc. 2013 Table of Contents Introducing the PDM Buyer s Guide... 3 The Product Data Management Imperative... 5 Analyze
More informationDATA INTEGRITY - THE FOUNDATION OF GOOD SCIENCE
TRUSTED ADVISORS TO HEALTHCARE AND LIFE SCIENCE EXECUTIVES DATA INTEGRITY - THE FOUNDATION OF GOOD SCIENCE DATA ALONE IS NOT GOOD ENOUGH By: Ellyn McMullin, Research Associate & Sandra K. Rodriguez, Market
More information5 Important Questions to Ask Potential BPM Vendors
5 Important Questions to Ask Potential BPM Vendors By Tripp Solomon, Product Marketing Manager GETTING STARTED WITH YOUR BPM INITIATIVE There are many elements to consider when embarking on a Business
More informationSpeed Business Performance, Lower Cost, and Simplify IT with Automated Archiving
SAP Brief SAP Extensions SAP Archiving and Document Access by OpenText Speed Business Performance, Lower Cost, and Simplify IT with Automated Archiving SAP Brief Store, manage, and access data and documents
More informationDemystify Governance, Risk & Compliance For Lifesciences
www.hcltech.com Demystify Governance, Risk & Compliance For Lifesciences Competitive global markets, more-demanding patients, regulations from multiple regulatory authorities and high product development
More informationProduct serialization and traceability mandates. kpmg.com
Product serialization and traceability mandates kpmg.com 1 Product serialization and traceability mandates Increasing threats to patient safety from counterfeited, adulterated, and diverted pharmaceutical
More informationMust-Have ERP Features for the Automotive Industry
Must-Have ERP Features for the Automotive Industry At a Glance: This paper summarizes the benefits an ERP solution provides to the entire manufacturing process from shop floor to top floor. Included are
More informationWHITE PAPER. Food Safety, From Farm to Fork. A Best-Practice Approach to Implementing a Food Safety Management System
WHITE PAPER Food Safety, From Farm to Fork A Best-Practice Approach to Implementing a Food Safety Management System Executive Summary Now, more than ever, all food chain stakeholders are required to demonstrate
More information7 Must-Have ERP Features for High Tech/Electronics Manufacturers
7 Must-Have ERP Features for High Tech/Electronics Manufacturers At a Glance High tech and electronics manufacturers are challenged to handle compressed product lifecycles, supply-chain agility, global
More informationWhen you have to be right. Tax & Accounting. Document Management: A Tax Season Planning Guide
When you have to be right Tax & Accounting Document Management: A Tax Season Planning Guide 2 Document Management: A Tax Season Planning Guide Perhaps more so than any other profession, accounting, tax
More informationARE YOU GOING DIGITAL WITHOUT A NET?
ARE YOU GOING DIGITAL WITHOUT A NET? Whether your business is embracing new digital technologies or moving to the cloud, your network needs to be up to the task. 2 ARE YOU GOING DIGITAL WITHOUT A NET?
More informationCompliant. Connected. Complete. White Paper: SOP Management as a Compliance Tool in FDA and ISO Environments
Compliant. Connected. Complete. : SOP Management as a Compliance Tool in FDA and ISO Environments Introduction From manufacturers to hospitals to the military, most organizations need standard operating
More information25% 22% 10% 10% 12% Modern IT shops are a mix of on-premises (legacy) applications and cloud applications. 40% use cloud only. 60% use hybrid model
CLOUD INTEGRATION Modern IT shops are a mix of on-premises (legacy) applications and cloud applications Most companies, including SMBs, use two or more software solutions to manage business operations.
More informationDEMYSTIFYING WORKFLOW
DEMYSTIFYING WORKFLOW ROADMAP TO FIRM SUCCESS Your guide to understanding workflow, why it s critical to firm success, and next steps for implementation. CPA.com - an AICPA Company AND PREVIOUS Page DEMYSTIFYING
More informationIBM Sterling B2B Integrator
IBM Sterling B2B Integrator B2B integration software to help synchronize your extended business partner communities Highlights Enables connections to practically all of your business partners, regardless
More informationAdvantages of construction-specific solutions over generic spreadsheet applications
Advantages of construction-specific solutions over generic spreadsheet applications Introduction Significant improvements in estimating productivity can be achieved by adopting a vertical (construction-specific)
More informationProficy * Plant Applications. GE Intelligent Platforms. Plant Performance Analysis and Execution Software
GE Intelligent Platforms Proficy * Plant Applications Plant Performance Analysis and Execution Software As a production manager, the key to unlocking the full performance potential of your manufacturing
More information22 ways to get the most out of OEE and lean manufacturing disciplines
automation technology & consulting 22 ways to get the most out of OEE and lean manufacturing disciplines Overall equipment effectiveness (OEE) and lean manufacturing have won many converts. These two disciplines
More informationWHITE PAPER. Managing the Intelligence Life Cycle: Title A More Effective Way to Tackle Crime
WHITE PAPER Managing the Intelligence Life Cycle: Title A More Effective Way to Tackle Crime ii Contents Executive Summary... 1 Organizational Drivers for a Flexible Framework... 1 Facing Up to the Challenges...
More informationTECNOMATIX. Upfront virtual processes improve quality and reduce cost. Waltonen Engineering. Multi-industry. Business challenges.
Multi-industry Upfront virtual processes improve quality and reduce cost uses to help manufacturers predict issues, avoid significant production problems and maximize profitability Business challenges
More informationSAP BusinessObjects Business Intelligence
SAP BusinessObjects Business Intelligence Increase Business Agility with the Right Information, When & Where it is Needed Disruptive innovation has resulted in a revolutionary shift in the way enterprises
More informationMedical Device Solution
Medical Device Solution How to Achieve FDA 21 Part 820 Compliance With Polarion Europe, Middle-East, Africa: Polarion Software GmbH Lautlinger Weg 3 70567 Stuttgart, GERMANY Tel +49 711 489 9969-0 Fax
More informationBuilding Integrated Quality Processes in Aerospace and Defense
Building Integrated Quality Processes in Aerospace and Defense For Aerospace and Defense (A&D) companies, high levels of communication and collaboration are required across the value chain to deliver quality
More informationTHE DIGITAL THREAD IMPERATIVE. High tech companies must make the right connections for new growth
THE THREAD IMPERATIVE High tech companies must make the right connections for new growth As the world becomes increasingly digital, high tech companies face a new reality: the speed of innovation is greater
More informationBe Remarkable. CONTRACT LIFECYCLE MANAGEMENT SOFTWARE. Software Overview OVERVIEW. Additional Available Professional Services
Be Remarkable. CONTRACT LIFECYCLE MANAGEMENT SOFTWARE Software Overview Greatly improves management of contracts and business agreements across your entire enterprise, maximizing the value of each and
More informationDIGITAL TRANSFORMATION WITH INTELLIGENT SOLUTIONS FROM INFOSYS AND PEGA
DIGITAL TRANSFORMATION WITH INTELLIGENT SOLUTIONS FROM INFOSYS AND PEGA Introduction Today, organizations want smart digital initiatives that can transform their business to drive top and bottom line growth.
More informationMulti Support Next Contracts. Cut costs, eliminate errors, and reduce risk. Handle your contracts and agreements without the hassle.
www.multi-support.com CONTRACT AGREEMENT Yellow Furniture 17 Multi Support Next Contracts Cut costs, eliminate errors, and reduce risk. Handle your contracts and agreements without the hassle. When you
More informationBlackLine Compliance
BlackLine Compliance The Compliance Imperative Compliance and Internal Audit teams are facing a complex regulatory and operating environment. Many teams are under significant cost pressure to improve efficiency
More information10 ways to make analytics more useful and consumable
Chemicals 10 ways to make analytics more useful and consumable Like most manufacturers, your chemical company is swimming in data that needs to be consumed quickly. You re coping with fluctuating commodity
More informationAudit Analytics. Delivered. Why Work With Us? CONSULTING. Leading analytics software. Fast, reliable service. We speak your language
CONSULTING Audit Analytics Delivered Why Work With Us? Leading analytics software CaseWare is a leading supplier of software for audit data analytics, continuous auditing, and continuous monitoring worldwide.
More informationUnderstanding IEC 62304
Understanding IEC 62304 Co-authored by MethodSense, Inc. and Medical Equipment Compliance Associates, LLC www.methodsense.com 919.313.3960 Understanding IEC 62304 By: Rita King, Chief Executive Officer,
More informationCHAPTER 2. Importance of CRM
CHAPTER 2 Importance of CRM - 26 - 2.1 - Introduction 2.2 - An Insight into CRM 2.3 - Importance of CRM 2.4 - Model for CRM in Banking Sector 2.5 - Need of Relationship with Customers 2.6 - Reaping the
More informationNovember Achieving CAD Interoperability in Global Product Design Environments. Interoperability: A recognized problem in search of a solution
Topic: CAD icad is produced by Business Advantage, a B2B research, business development and marketing consulting practice operating in the global IT, Digital and Telecommunication s sectors. Achieving
More informationTech-Clarity Perspective: Best Practices for Managing Design Data. How Effective Data Management Fundamentals Enable World-Class Product Development
Tech-Clarity Perspective: Best Practices for Managing Design Data How Effective Data Management Fundamentals Enable World-Class Product Development Tech-Clarity, Inc. 2012 Table of Contents Executive Overview...
More informationIBM Data Security Services for activity compliance monitoring and reporting log analysis management
Improving your compliance posture and reducing risk through log analysis management IBM Data Security Services for activity compliance monitoring and reporting log analysis management Highlights Provide
More informationIntegration and infrastructure software Executive brief May The business value of deploying WebSphere Portal software in an SOA environment.
Integration and infrastructure software Executive brief May 2006 The business value of deploying WebSphere Portal software in an SOA environment. Page 2 Contents 2 Executive overview 3 Why SOA? 5 The evolution
More informationDecember How to Build Customer Loyalty with Data and Document Management
December 2016 How to Build Customer Loyalty with Data and Document Management Executive Summary Executive Summary Today s digitally-driven business environment is transforming the way organizations communicate
More informationWhite Paper Microsoft SharePoint for Engineering Document Management and Control
www.cadac.com White Paper Microsoft SharePoint for Engineering Document Management and Control Microsoft SharePoint is a powerful platform for document management and project collaboration. Many project-driven
More informationWhite paper Audits in automated production
White paper Audits in automated production data management for automation Introduction: Audits in automated production In the field of production management, audits have become an important tool for analysing
More informationReimagine productivity with Microsoft Dynamics 365
Reimagine productivity with Microsoft Dynamics 365 Transform business process automation and people productivity with Microsoft Dynamics 365 and the Microsoft Cloud Customer Service Financials Operations
More informationCENTRE (Common Enterprise Resource)
CENTRE (Common Enterprise Resource) IT Service Management Software designed for ISO 20000 ITSM ISO/IEC 20000 is the international IT Service Management (ITSM) standard that enables IT organizations (whether
More informationKey Elements of Quality Assurance in the Good Laboratory Practice (GLP) Environment
Key Elements of Quality Assurance in the Good Laboratory Practice (GLP) Environment The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system concerned with
More informationTRACEABILITY: SOLVING CHALLENGES & ADDING VALUE IN ELECTRONICS MANUFACTURING
TRACEABILITY: SOLVING CHALLENGES & ADDING VALUE IN ELECTRONICS MANUFACTURING By Rob Prosser, global product manager, industrial ID materials, Brady Corporation Last updated: May 2014 TRACEABILITY: SOLVING
More informationWHITE PAPER. Reducing Audit Fatigue in Five Steps
WHITE PAPER Reducing Audit Fatigue in Five Steps Reducing Audit Fatigue in Five Steps RizePoint White Paper YOU NEED AUDITS TO ENSURE PUBLIC SAFETY IN TODAY S HYPER-CONNECTED WORLD. BY HELPING STATE GOVERNMENT
More informationInfor Food & Beverage for the dairy industry
Food & Beverage Infor Food & Beverage for the dairy industry Always be prepared for the next day s shipment Dairies like yours differ greatly from each other in many ways. You may produce a variety of
More informationRaising Quality Results on Supplier Audits Using EQMS for Pharmaceutical Companies. Whitepaper
Raising Quality Results on Supplier Audits Using EQMS for Pharmaceutical Companies Whitepaper Executive Summary Supply chain integrity is necessary to a pharmaceutical company s success. Formal contracts,
More informationCase Study: Broadcom Limited
Case Study: Broadcom Limited Broadcom Limited relies on Okta to ease acquisitions and increase productivity Overview Industry Semiconductors Company Profile Broadcom Limited (NASDAQ: AVGO) is a leading
More information2 BRAXTON WAY, SUITE 105, GLEN MILLS, PA P: F:
9 Must Have Generation Outage Outage management systems are becoming a core component of an energy utility s application landscape. Just like Bid-to-Bill, EMS/SCADA, or ETRM systems, outage management
More informationThe Economic Benefits of Puppet Enterprise
Enterprise Strategy Group Getting to the bigger truth. ESG Economic Value Validation The Economic Benefits of Puppet Enterprise Cost- effectively automating the delivery, operation, and security of an
More informationThe Future of Quality Management Systems -
The Future of Quality Management Systems - Using Technology to Your Advantage Bill.Horricks@HorricksManagementGroup.com www.linkedin.com/in/billhorricks www.cissoftware.com The 3 Questions in Life A Big
More informationAsset Management. Manage all of your assets in one modern, easy-to-use app
Asset Management Manage all of your assets in one modern, easy-to-use app Asset Management Transform your asset management efficiency whether you re managing in-house equipment or providing asset management
More informationContract Management in the Age of Digital Transformation: Improve your Processes for Better Business Outcomes. A Frost & Sullivan White Paper
A Frost & Sullivan White Paper frost.com Introduction...3 Digital Transformation is Changing Everything...4 Re-examining the Contract Lifecycle...4 What to Look for in a CLM Solution...6 Conclusion...7
More informationProblem solved: Digital Business Automation
Problem solved: Digital Business Automation 2 Create a fast, business-driven transformation using proven digital business Digital business automation is creating huge opportunities to transform experiences,
More informationOrchestrated. Development Management. How to Strike the Right Balance between Speed and Control
Orchestrated Development Management How to Strike the Right Balance between Speed and Control Solution Brief Challenges Enterprise IT organizations are facing seismic shifts in how they can more rapidly
More informationAchieve Powerful Business Benefits by Streamlining Document Workflows
INSURANCE BEST PRACTICES Achieve Powerful Business Benefits by Streamlining Document Workflows 2016 Hanover Research FORCES RESHAPING THE INSURANCE INDUSTRY World class insurance organizations have two
More informationA practical guide to more effective collaboration
A practical guide to more effective collaboration How to choose the most productive collaboration tools to overcome the 5 key issues affecting workplace communication. The workforce is rapidly changing.
More informationConquering complexity in the customer experience
Conquering complexity in the customer experience Insights to help you get the most from SAP C/4HANA and the SAP Intelligent Suite As today s digital business environment continues to grow more complex,
More informationModernizing Quality Management
Modernizing Quality Management Priya Durvasula Head of IT, Global Quality Raghunandan Satyanarayan Associate Director September 17, 2018 1 Speaker Information Priya Durvasula, PhD Head of IT, Global Quality
More informationWHY YOU SHOULD HAVE A DIGITAL MAILROOM Take the First Hurdle in the Digitization of your organization
WHY YOU SHOULD HAVE A DIGITAL MAILROOM Take the First Hurdle in the Digitization of your organization A document on why, how and what considerations and questions you should have before embarking on the
More informationIBM Rational RequisitePro
Success starts with requirements management IBM Rational RequisitePro Highlights Offers advanced Microsoft Provides Web access for Word integration distributed teams Built on a robust Offers flexible reporting
More information