The SaaS LMS and Total Cost of Ownership in FDA-Regulated Companies
|
|
- Simon Harrell
- 8 years ago
- Views:
Transcription
1 The SaaS LMS and Total Cost of Ownership in FDA-Regulated Companies
2 The SaaS LMS and Total Cost of Ownership in FDA-Regulated Companies By Rob Sims, Director, Life Science, UL EduNeering When a Life Science company is evaluating corporate Learning Management Systems (LMS), calculating a total cost of ownership (TCO) often takes a back seat to gathering the organization s functional and IT requirements. This is understandable, given that Quality Assurance executives must ensure the LMS can satisfy their quality and regulatory goals: qualifications, audit reports, management visibility, etc. However, we have seen that spending some time on TCO has the potential to narrow the focus for an evaluation team that s composed of IT, HR, Procurement and Finance representatives. And when TCO is placed at the forefront of evaluation criteria, more and more organizations will understand why the SaaS-based LMS has grown so popular. In the past five years, the cloud computing adoption has grown steadily. According to a July 2012 CompTIA report, 93% of companies are using some form of cloud solution. And Gartner predicts cloud computing will grow by over 100% to be a $207 billion industry by 2016, while the overall global IT market is forecast to grow at just 3%. TCO is a primary driver for any SaaS (Software as a Service) solution, as a SaaS application typically includes pay-as-you-go pricing, requires less IT resources, no hardware investment, no disaster recovery investment and no hardware maintenance costs. For FDA regulated companies, the most significant cost advantage involves the reduced validation effort, both at start-up and in subsequent years. For many organizations, the validation effort is a time-consuming, resource-intensive process. However, with the SaaS LMS, validation becomes a shared responsibility between the client and the vendor, and this distribution of resources reduces the validation costs significantly, especially when the software is upgraded. That s because with a server-based application, the client s engineering and IT personnel are responsible for designing and maintaining the internal data center, computer hardware, software, security, disaster recovery, etc. And the client s Quality Assurance (QA) team conducts quality and validation activities on the single LMS software code. In the SaaS model, several critical functions of QA, IT and validation are shifted to the SaaS vendor making the SaaS vendor audit a critical activity for the client s validation, auditing, IT and QA team. Page 2
3 Adhering to FDA Validation & 21 CFR Part 11 Regulations The FDA defines software validation as confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. (source: Even when a software vendor has a well defined process, each business is expected to ensure that the organization s use of the software is validated. The FDA expects developers to follow controls and procedures that are specified in a Software Development Life Cycle (SDLC) to ensure quality. The FDA requires that appropriate testing be performed, and this is achieved by executing test scripts that map back to the software requirements. Testing often consists of Installation Qualification (IQ), in which documentation verifies that the system is installed according to written specifications; Operational Qualification (OQ), in which documentation verifies that the system operates throughout all operating ranges; and Performance Qualification (PQ), in which tests must span the underlying cgmp business process, to ensure that users and administrators trained in the SOPs can accomplish business objectives in the production environment. In addition to validation requirements, the system must meet electronic record and electronic signature requirements as outlined in 21 CFR Part 11. Here are just three critical requirements of Part 11: KEY TOPICS: Adhering to FDA Validation & 21 CFR Part 11 Regulations The LMS Deployment: Auditing the LMS Vendor Reducing Costs Following the Deployment Summary Audit Trails: Use of time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify or delete electronic records. Authority Checks: Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record or perform the operation at hand. Electronic Records: Signed electronic records need to contain information associated with the signing that clearly indicates these three items: 1) the printed name of the signer; 2) the date and time the signature was executed; and 3) the meaning (such as review, approval, responsibility or authorship) associated with the signature. In a similar way, EU Annex 11 also focuses on the product life cycle, as well as user requirements related to each system. However, Annex 11 places more emphasis on people and management accountability than FDA regulations specifically the individuals with responsibility for the business process and system maintenance. To address these regulatory obligations, clients perform a number of activities: create the Solution Design Document (SDD), develop User and Functional Requirements, develop test scripts and conduct IQ, OQ and PQ testing, among other activities. This effort drives up the IT and validation teams time and effort, and often adds months to any software implementation or enhancement project. Page 3
4 With a SaaS-based LMS, clients can rely on the vendor to perform and maintain some of these activities. The effort for the client, then, focuses initially on an audit of the data center, as well as the vendor s QA and validation methodology, to ensure these activities are performed at the same standard as would be performed by the client s own QA and validation teams. Typically, the three days or so taken to audit a vendor can dramatically reduce the time spent validating the system. The LMS Deployment: Auditing the LMS Vendor For the SaaS LMS, clients often conduct an audit of the vendor at the vendor s primary location, so the vendor can demonstrate adherence to quality software engineering and testing principles. The client s validation teams will typically review QA documentation and project files that were developed as part of the design, development, testing and implementation of the LMS. The vendor s QA team will need to demonstrate that a valid development methodology is in place and that thorough testing was used to provide confidence and assurance to the client that the LMS is fit for production use. Furthermore, the vendor s QA team must demonstrate that it is involved with these activities, which should occur throughout the entire SDLC stage: Business rules, graphical user interface design elements and interoperability with existing features Functional specification IQ and OQ Process for system releases to clients Test traceability and full product testing before any new LMS code is released to a production environment Typically, when a client audits ComplianceWire, our SaaS-based LMS, these are the documents that are usually requested for review: Business Requirements: This document focuses on the needs of the user and spells out exactly what the system will do Functional Requirements: This document focuses on how the system will do what the user is expecting System Design: This document focuses on capturing the system design based on the functional requirements. Depicting screen layout, system functions and other aspects of the user experience to fulfill the business requirements Requirements Traceability Matrix: This document captures the relationship between the business and functional requirements and the test scripts that satisfy them; this document should reflect the latest enhancements made to the platform Test Scripts: These documents support new enhancements or custom projects. These scripts should cover basic platform functionality, CFR functional and reporting features and high priority areas of the LMS. In addition, custom testing should be executed for any custom programming performed Page 4
5 Test Plan (TP) and Validation Plan (VP) SOPs: Because ComplianceWire is a single platform, these documents have been adopted as Standard Operating Procedures Validation Summary Report (VSR): This report summarizes our testing activities, discrepancies and other validation activities In many cases, when clients subscribe to ComplianceWire, following an audit of our data center and SDLC methodology, a client s audit and validation team can then focus on creating these documents: Validation Plan: Describes the internal activities that are of part of the overall validation approach to be conducted by the client User Requirements Specification: Provides details on the functionality that the clients demands from ComplianceWire. These required items are often categorized as critical, mandatory or nice to have, and are the basis for the validation/testing effort User Acceptance Test Scripts: Clients should have their own test scripts that either augment our own QA test scripts, or unique scripts that demonstrate that the company has tested specific usage of the system Validation of Configurations and Customizations: Clients often test their specific configurations of ComplianceWire (Security Roles, Custom Fields, Reports, etc.) and any customized solutions The following table summarizes the typical responsibilities as described above. Typical SaaS LMS Validation Responsibilities Vendor Documents Shared During an Audit: Business Requirements Functional Requirements System Design Requirements Traceability Matrix Client Responsibilities: Validation Plan User Requirements Specification User Acceptance Test Scripts Validation of Configurations and Customizations Test Scripts Test Plan and Validation Plan SOPs Validation Summary Report (VSP) Page 5
6 Reducing Costs Following the Deployment With a server-based LMS, the vendor s release schedule determines ongoing validation/ re-validation activities, and has the potential to drive up TCO, as it impacts the resources of QA, validation and IT. One client noted that IT staff costs associated with periodic review of the server-based LMS, to ensure that validation status has been sustained, is often not noted in the LMS TCO. And for many of our clients who previously relied on a server-based LMS, the costs of re-validating the software prevented them from upgrading the software to a new version, and thus not gaining the benefits of these new features. With a SaaS LMS, the vendor can reduce this effort. First, the vendor can provide clients with a preview period that includes the ability to test the new features on the vendor s test site. Regression test scripts should be provided to aid the client with their own internal validation effort. The vendor should also provide a validation summary report at the end of all release activities. Based on conversations with clients who have actually migrated from a server-based LMS to a SaaS-based LMS, we ve created two scenarios based on a large company (10,000 employees) and a small to mid-size company (500 employees). While the cost assumptions are not based on any single LMS implementation, we do consider actual costs conveyed to us from clients who have migrated their LMS from a server-based LMS, factoring in the cost of IT staff, validation staff and external IT contractors who are involved in the server-based installation and ongoing maintenance. Please note that we do not factor in the migration of historical data, as this cost will vary depending on the amount of historical data to be migrated, regardless of whether the LMS is server-based or SaaS. In both company scenarios, the Year 1 validation cost savings are reduced by the SaaS LMS, as this requires significantly less IT and validation resources. However, cost savings of the SaaS LMS continue during Year 2 through Year 5, because the validation team doesn t have to validate the entire software and IT infrastructure with each software enhancement. This benefit occurs regardless of company size. What we have seen is that in some cases, SaaS provides additional benefits to the small to mid-size company, as it provides built-in scalability to accommodate new users and expand operations without placing a burden on IT infrastructure. Some organizations consider IT and validation resources as a sunk cost because employees are performing the work. As our clients have pointed out, the server-based LMS upgrade still requires a great deal of effort, and to neglect the opportunity costs (the cost of passing by the second-best option when making a decision) associated with employees is an oversight. To paraphrase one client: Other software projects are sacrificed, sometimes for months, when the IT and validation teams have to perform a single server-based upgrade. For that reason, in the scenarios that follow, we have presented costs associated with a server-based implementation that includes IT resources. Page 6
7 Scenario #1: Large Company 10,000 Global Users Year 1 LMS Cost Comparison Budget: Server Based SaaS Purchase of Licenses $300K - Subscription Fee - $300K 20% Annual Maintenance Fee $60K - Purchase of Hardware/Storage $330K - IT Support $120K - Project Management & Validation Configuration & Interface Dev $500K $50K $350K $75K Total Year 1 Budget: $1.66M $425K Scenario #2: Emerging Company 500 Global Users Year 1 LMS Cost Comparison Budget: Server Based SaaS Purchase of Licenses $25K - Subscription Fee - $25K 20% Annual Maintenance Fee Purchase of Hardware/Storage $5K - $20K - IT Support $10K - Project Management & Validation Configuration & Interface Dev $50K $10K $30K $10K Total Year 1 Budget: $140K $45K Year 2 through Year 5 Cost Comparison Budget: Server Based SaaS Subscription Fee - $1.2M 20% Annual Maintenance Fee Purchase of Hardware/Storage $240K - $120K - IT Support $480K - Validation Related to Upgrades $1M $100K Total Year 2 5 Budget: $1.84M $1.3M Total Year 1 5 Budget: $3.5M $1.725M Total Cost Difference Over Five Years: Companies Save $1.7M with the SaaS LMS Year 2 through Year 5 Cost Comparison Budget: Server Based SaaS Subscription Fee - $100K 20% Annual Maintenance Fee $20K - Purchase of Hardware/Storage 10K - IT Support $40K - Validation Related to Upgrades $120K $10K Total Year 2 5 Budget: $190K $110K Total Year 1 5 Budget: $330K $155K Total Cost Difference Over Five Years: Companies Save $175K with the SaaS LMS Summary: The SaaS LMS has been positioned to allow small and mid-sized companies to gain quality-focused functionality that addresses FDA regulatory needs, while also being scalable to accommodate future growth. From our real-world experience with our clients, we know that a SaaS LMS designed to address FDA validation requirements can lower the total cost of ownership, while also providing predictability of costs over time. Further, SaaS LMSs have been shown to provide reliable access to data anywhere, anytime via a web browser, to accommodate remote employee usage, as well as non-employee training that spans suppliers, clinical sites, vendors, agents and contractors. The critical question that Quality Assurance executives can ask during the evaluation phase is, What will our costs be when the software is upgraded in Years 2 through 5? When the IT team and the validation team estimate the time required of server-based resources, they will be able to calculate the opportunity costs for annual upgrades. Factoring in IT and validation resource costs, as well as the hardware and software maintenance costs related to the server-based LMS, are at the heart of the growth of the SaaS LMS within the FDA-regulated organization. Page 7
8 About UL EduNeering UL EduNeering is a business line within UL Life & Health s Business Unit. UL is a global independent safety science company offering expertise across five key strategic businesses: Life & Health, Product Safety, Environment, Verification Services and Enterprise Services. UL EduNeering develops technology-driven solutions to help organizations mitigate risks, improve business performance and establish qualification and training programs through a proprietary, cloud-based platform, ComplianceWire. For more than 30 years, UL has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance management approach integrates ComplianceWire, training content and advisory services, enabling clients to align learning strategies with their quality and compliance objectives. Since 1999, under a unique partnership with the FDA s Office of Regulatory Affairs (ORA), UL has provided the online training, documentation tracking and 21 CFR Part 11-validated platform for ORA-U, the FDA s virtual university. Additionally, UL maintains exclusive partnerships with leading regulatory and industry trade organizations, including AdvaMed, the Drug Information Association, the Personal Care Products Council and the Duke Clinical Research Institute. 202 Carnegie Center Suite 301 Princeton, NJ UL and the UL logo are trademarks of UL LLC uleduneering.com WP/13/120513/LS
A Model for Training/Qualification Record Validation within the Talent Management System
A Model for Training/Qualification Record Validation within the Talent Management System IN THIS PAPER: Meeting 21 CFR Part 11 and Annex 11 Requirements Delivering Qualification Transcripts During Audits
More informationA Quality and Compliance Training Road Map for Emerging FDA-Regulated Companies
A Quality and Compliance Road Map for Emerging FDA-Regulated Companies A Quality and Compliance Road Map for Emerging FDA-Regulated Companies Quality and compliance leaders within emerging Life Science
More informationHow Companies Can Reduce Costs with Cloud-Based Training
How Companies Can Reduce Costs with Cloud-Based Training How Companies Can Reduce Costs with Cloud-Based Training Today s volatile economic climate has many regulated companies thinking differently about
More informationLearning Management System Evaluation Guide
Learning Management System Evaluation Guide With more than 400 companies with sites in 30 countries, and over 35 million training assignments completed, UL EduNeering is in a unique position to share best
More informationQuality and Compliance: The Core of the Life Science Learning System
Quality and Compliance: The Core of the Life Science Learning System Quality and Compliance The Core of the Life Science Learning System By Rob Sims, Director, Life Science, UL EduNeering Within today
More informationClinical Training Management
Clinical Training Management Learning and Compliance for Clinical Research Helping to Fuel the Growth of CROs and Service Providers According to clinical researcher CenterWatch, the FDA and global regulatory
More informationBest Practices for Deploying a Learning Management System
Best Practices for Deploying a Learning Management System Best Practices for Deploying a Learning Management System As many of today s regulated companies continue to expand globally and focus on outsourcing
More informationBenefits of Cloud Computing for Compliance Learning
Benefits of Cloud Computing for Compliance Learning By Paul McFadden, VP of Technology, UL EduNeering In this paper we will cover how companies can benefit from the Cloud Computing Learning Environment
More informationLibrary Guide: HIPAA
Library Guide: HIPAA Page 2 Table of Contents Overview...2 Course Descriptions: Privacy and Security Library: Business Practices to Protect Personal Health Information (HIPAA05)... 3 HIPAA: General Awareness
More informationTop Seven Risks to Consider When Selecting a Life Science LMS
Top Seven s to Consider When Selecting a Life Science LMS THE UNINTENDED CONSEQUENCES OF UNINFORMED DECISIONS IN THIS PAPER: Identifying and avoiding gaps in LMS functionality that may lead to critical
More informationCustom Course Development Services
Custom Course Development Services Turn Your Training into a Competitive Advantage Other than your people, your organization s greatest competitive advantage resides in your unique processes, systems and
More informationUsing Training Data to Drive Up Quality Metrics SURVEY OF QUALITY ASSURANCE EXECUTIVES
Using Training Data to Drive Up Quality Metrics SURVEY OF QUALITY ASSURANCE EXECUTIVES SURVEY OF QUALITY ASSURANCE EXECUTIVES The FDA s Push for Data and Metrics For the US FDA investigator, the single
More informationValidated SaaS LMS SuccessFactors Viability
Validated SaaS LMS SuccessFactors Viability Executive Summary SuccessFactors has a long history of working with validated organizations and has brought this expertise to their validated SaaS LMS package.
More informationMaking SOP Training More Effective
By David Peterson, Director, GMP and Quality Systems, UL EduNeering SOPs are critical to efficient operations, quality control and regulatory compliance. This paper reviews best practices for the Life
More informationComplianceWire COMPLIANCE MANAGEMENT FOR LIFE SCIENCE ORGANIZATIONS
ComplianceWire COMPLIANCE MANAGEMENT FOR LIFE SCIENCE ORGANIZATIONS COMPLIANCE. PROFICIENCY. PERFORMANCE. ComplianceWire, the best-in-class solution for regulated industries, is a powerful, Part 11 compliant
More informationCustom Courses THAT SATISFY BOTH YOUR BUSINESS AND BUDGET NEEDS
Custom Courses THAT SATISFY BOTH YOUR BUSINESS AND BUDGET NEEDS It is important to create great training courses that are cost effective, yet meet an organization s business drivers and training requirements.
More informationValidation Best Practice for a SaaS
Validation Best Practice for a SaaS UL and the UL logo are trademarks of UL LLC 2012 Validation Best Practice for SaaS Validation Definition: Establishing documented evidence which provides a high degree
More informationComplianceWire COMPREHENSIVE TRAINING SOLUTIONS FOR OPERATIONALLY EXCELLENT ORGANIZATIONS
ComplianceWire COMPREHENSIVE TRAINING SOLUTIONS FOR OPERATIONALLY EXCELLENT ORGANIZATIONS COMPREHENSIVE TRAINING SOLUTIONS FOR OPERATIONALLY EXCELLENT ORGANIZATIONS ComplianceWire provides enterprise-wide
More informationHow CMOs are Turning Their Training Programs into Market Differentiators
How CMOs are Turning Their Training Programs into Market Differentiators How CMOs are Turning Their Training Programs into Market Differentiators A Contract Manufacturing Organization (CMO) has as much
More informationSage ERP I White Paper. ERP and the Cloud: What You Need to Know
I White Paper ERP and the Cloud: What You Need to Know Table of Contents Executive Summary... 3 Increased Interest in Cloud-Based ERP and SaaS Implementations... 3 What is Cloud/SaaS ERP?... 3 Why Interest
More informationIntroduction to Cloud Computing What is SaaS? Conventional vs. SaaS Methodologies Validation Requirements Change Management Q&A
Best Practices for Validation of a Software as a Service (SaaS) Customer Relationship Management (CRM) Solution Presented By: Gregg Mauriello Validation Manager Elise Miner Associate Validation Manager
More informationINTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to
INTRODUCTION This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software
More informationComplianceSP 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 informationABSTRACT INTRODUCTION WINDOWS SERVER VS WINDOWS WORKSTATION. Paper FC02
ABSTRACT Paper FC02 Implementing SAS using Microsoft Windows Server and Remote Desktop Paul Gilbert, DataCeutics, Inc., Pottstown, PA Steve Light, DataCeutics, Inc., Pottstown, PA DataCeutics provides
More informationPharmaceutical, Biotech and Medical Device Manufacturers. Be Compliant and Audit Ready - Implement an LMS!
Pharmaceutical, Biotech and Medical Device Manufacturers Be Compliant and Audit Ready - Implement an LMS! Organizations in the life sciences industry such as pharmaceuticals, medical devices and biotech
More informationLIBRARY GUIDE: Pharmaceutical Sales & Marketing
LIBRARY GUIDE: Pharmaceutical Sales & Marketing Page 2 Pharmaceutical Sales and Marketing Course Library Table of Contents: Courses Listed by Functional Area... 4 Basics of the PhRMA Code (PHSM01)...5
More informationValidating 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 informationServices Providers. Ivan Soto
SOP s for Managing Application Services Providers Ivan Soto Learning Objectives At the end of this session we will have covered: Types of Managed Services Outsourcing process Quality expectations for Managed
More informationConsiderations When Validating Your Analyst Software Per GAMP 5
WHITE PAPER Analyst Software Validation Service Considerations When Validating Your Analyst Software Per GAMP 5 Blair C. James, Stacy D. Nelson Introduction The purpose of this white paper is to assist
More informationTesting Automated Manufacturing Processes
Testing Automated Manufacturing Processes (PLC based architecture) 1 ❶ Introduction. ❷ Regulations. ❸ CSV Automated Manufacturing Systems. ❹ PLCs Validation Methodology / Approach. ❺ Testing. ❻ Controls
More informationRisk-Based Validation of Computer Systems Used In FDA-Regulated Activities
September 2, 2003 Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities Purpose This document provides a summary of the requirements relating to use of computer-based systems in activities
More informationTIBCO Spotfire and S+ Product Family
TIBCO Spotfire and S+ Product Family Compliance with 21 CFR Part 11, GxP and Related Software Validation Issues The Code of Federal Regulations Title 21 Part 11 is a significant regulatory requirement
More informationLIBRARY GUIDE: Clinical Medical Device
LIBRARY GUIDE: Clinical Medical Device Table of Contents Overview... 3 Clinical Curriculum Core Program Course Descriptions: A Tour of Health Canada (PHDV89)...5 A Tour of Health Europe (PHDV90)...5 A
More informationLIFE SCIENCES QAD SOLUTIONS ARE BUILT FOR LIFE SCIENCES MANUFACTURERS, BUILT FOR YOU
QAD SOLUTIONS ARE BUILT FOR LIFE SCIENCES MANUFACTURERS, BUILT FOR YOU The global life sciences industry continues to experience dramatic change. Life sciences manufacturers remain dedicated to innovation,
More informationHow To Integrate With Salesforce Crm
Introduction Turbo-Charge Salesforce CRM with Dell Integration Services By Chandar Pattabhiram January 2010 Fueled by today s fiercely competitive business environment, IT managers must deliver rapid,
More informationConsiderations for validating SDS Software v2.x Enterprise Edition for the 7900HT Fast Real-Time PCR System per the GAMP 5 guide
WHITE PAPER SDS Software v2.x Enterprise Edition Considerations for validating SDS Software v2.x Enterprise Edition for the 7900HT Fast Real-Time PCR System per the GAMP 5 guide This white paper describes
More informationLIBRARY GUIDE: Medical Device Sales & Marketing
LIBRARY GUIDE: Medical Device Sales & Marketing Page 2 Table of Contents Overview... 2 About Our Health Care Compliance Solution... 2 Our Relationship With AdvaMed... 2 Course Descriptions: Basics of the
More informationMOVING TO THE CLOUD: Understanding the Total Cost of Ownership
MOVING TO THE CLOUD: Understanding the Total Cost of Ownership The most significant cost of owning and managing software applications is tied up in operating and maintaining the software, along with the
More informationWHY CLOUD COMPUTING MAKES SENSE FOR NONPROFITS
WHY CLOUD COMPUTING MAKES SENSE FOR NONPROFITS Nonprofits are experiencing increased pressure, oversight, and demand for transparency from all sides. Whether the focus is government compliance, competition
More informationCloud Computing: What needs to Be Validated and Qualified. Ivan Soto
Cloud Computing: What needs to Be Validated and Qualified Ivan Soto Learning Objectives At the end of this session we will have covered: Technical Overview of the Cloud Risk Factors Cloud Security & Data
More informationHow to Turn the Promise of the Cloud into an Operational Reality
TecTakes Value Insight How to Turn the Promise of the Cloud into an Operational Reality By David Talbott The Lure of the Cloud In recent years, there has been a great deal of discussion about cloud computing
More informationContact Centers in the Cloud: A Better Way to Source
Contact Centers in the Cloud: A Better Way to Source By Irwin Lazar Vice President and Service Director, Nemertes Research Executive Summary Contact Center Software as a Service (CCSaaS) solutions provide
More informationMoving Network Management from OnSite to SaaS. Key Challenges and How NMSaaS Helps Solve Them
Moving Network Management from OnSite to SaaS Key Challenges and How NMSaaS Helps Solve Them Executive Summary In areas such as sales force automation and customer relationship management, cloud-based
More informationCloud Computing and SaaS Environments
Regulatory Considerations for Use of Cloud Computing and SaaS Environments Institute of Validation Technology Conference Qualifying and Validating Cloud and Virtualized IT Infrastructure Philadelphia PA
More informationKey Benefits of Microsoft Visual Studio Team System
of Microsoft Visual Studio Team System White Paper November 2007 For the latest information, please see www.microsoft.com/vstudio The information contained in this document represents the current view
More informationTHE QUEST FOR A CLOUD INTEGRATION STRATEGY
THE QUEST FOR A CLOUD INTEGRATION STRATEGY ENTERPRISE INTEGRATION Historically, enterprise-wide integration and its countless business benefits have only been available to large companies due to the high
More informationOrganizations that are standardizing today are enjoying lower management costs, better uptime. INTRODUCTION
WHITEPAPER STANDARDIZED OPERATING ENVIRONMENTS FOR I.T. EFFICIENCY Boost productivity, increase uptime, and enhance business agility by standardizing your IT environment INTRODUCTION Organizations that
More informationProcessing invoices in the cloud or on premises pros and cons
WHITE PAPER Purchase-to-pay by ReadSoft. Automated account payables processing software Author: Wille Dahl March 2012 Copyright ReadSoft - www.readsoft.com Processing invoices in the cloud or on premises
More informationProtecting Patient Data in the Cloud With DLP An Executive Whitepaper
Protecting Patient Data in the Cloud With DLP An Executive Whitepaper. Overview Healthcare and associated medical record handling organizations have, for many years, been utilizing DLP, Data Loss Prevention
More informationThe Cloud in Regulatory Affairs - Validation, Risk Management and Chances -
45 min Webinar: November 14th, 2014 The Cloud in Regulatory Affairs - Validation, Risk Management and Chances - www.cunesoft.com Rainer Schwarz Cunesoft Holger Spalt ivigilance 2014 Cunesoft GmbH PART
More informationImplementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E.
Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. President & CEO Agenda Introduction Who is Malisko Engineering? Title
More informationWork Your Core: Benefits of SaaS Investment Accounting and Reporting
Work Your Core: Benefits of SaaS Investment Accounting and Reporting Work Your Core: Benefits of SaaS Investment Accounting and Reporting These firms are not marginalizing their in-house expertise or compliance
More informationMHRA GMP Data Integrity Definitions and Guidance for Industry January 2015
MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This
More informationCONTENTS. List of Tables List of Figures
Prelims 13/3/06 9:11 pm Page iii CONTENTS List of Tables List of Figures ix xi 1 Introduction 1 1.1 The Need for Guidance on ERP System Validation 1 1.2 The Need to Validate ERP Systems 3 1.3 The ERP Implementation
More informationCloud Computing in a Regulated Environment
Computing in a Regulated Environment White Paper by David Stephenson CTG Regulatory Compliance Subject Matter Expert February 2014 CTG (UK) Limited, 11 Beacontree Plaza, Gillette Way, READING, Berks RG2
More informationGET CLOUD EMPOWERED. SEE HOW THE CLOUD CAN TRANSFORM YOUR BUSINESS.
GET CLOUD EMPOWERED. SEE HOW THE CLOUD CAN TRANSFORM YOUR BUSINESS. Cloud computing is as much a paradigm shift in data center and IT management as it is a culmination of IT s capacity to drive business
More informationCollaborative Portal Decisions That Make Cents
White Paper Covisint Collaborative Portal Decisions That Make Cents Reducing Total Cost of Ownership by 50% or More with SaaS Solutions Traditionally, large IT organizations have utilized their resources
More informationGETTING THE MOST FROM THE CLOUD. A White Paper presented by
GETTING THE MOST FROM THE CLOUD A White Paper presented by Why Move to the Cloud? CLOUD COMPUTING the latest evolution of IT services delivery is a scenario under which common business applications are
More informationOverview of EAM Services. A Fully Integrated Global EAM Service Provider
A Fully Integrated Global EAM Service Provider Table of Contents Strategy & Process Services Overview... p. 3 Asset Reliability Services Overview... p. 4 Systems & Technology Services Overview... p. 7
More informationBalancing cgmp vs. SOX. Compliance Guidances
Balancing cgmp vs. SOX Compliance Guidances Invensys Operations Management Douglas L. Lively CQA, PMP 110 New Bingham Ct., Cary, NC 27513 Revision: New Document Issue Date: July 16 th, 2009 TABLE OF CONTENTS
More informationSage ERP The top five reasons to deploy your ERP Solution in the cloud
Sage ERP The top five reasons to deploy your ERP Solution in the cloud 1 Table of contents Executive summary 3 Are you outgrowing your business solution? 3 SMBs want ERP 3 Budget and IT resource constraints
More informationTraditionally, large IT organizations have utilized their own
White Paper Cloud Identity Services Cloud Identity Services TCO Substantially Reducing Cost with Cloud Identity Services Traditionally, large IT organizations have utilized their own resources to design,
More informationValidation of a Cloud-Based ERP system, in practice. Regulatory Affairs Conference Raleigh. 8Th September 2014
Validation of a Cloud-Based ERP system, in practice. Regulatory Affairs Conference Raleigh. 8Th September What is the The Cloud Some Definitions The NIST Definition of Cloud computing Cloud computing is
More informationAchieving high performance with Accenture s on-demand solution for the chemical industry. Driving business performance with SAP Business ByDesign
Achieving high performance with Accenture s on-demand solution for the chemical industry Driving business performance with SAP Business ByDesign 2 Accenture helps small to mid-size companies and subsidiaries
More informationwww.hcltech.com Clinical Platform Compliance in the Cloud
www.hcltech.com Clinical Platform Compliance in the Cloud Application Services and Infrastructure HCL s Clinical Platform as a Service (CPaaS) is the first GxP compliant clinical information management
More informationRegulated 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 informationGAMP5 - a lifecycle management framework for customized bioprocess solutions
GE Healthcare Life Sciences GAMP5 - a lifecycle management framework for customized bioprocess solutions imagination at work GE Healthcare s engineering department, Customized Bioprocess Solutions (CBS),
More informationGet Significant Application Quality Improvement without Major Investment Performance driven. Quality assured.
Testing Platform-as-aService Get Significant Application Quality Improvement without Major Investment Performance driven. Quality assured. TPaaS providing testing on demand, using the Capgemini Cloud Application
More informationQualification Guideline
Qualification Guideline June 2013 Disclaimer: This document is meant as a reference to Life Science companies in regards to the Microsoft O365 platform. Montrium does not warrant that the use of the recommendations
More informationTwo Roads to Mobile Workforce Management: Choosing Between On-Premises and Cloud Delivery
A UBM techweb white paper MARCH 2012 Two Roads to Mobile Workforce Management: Choosing Between On-Premises and Cloud Delivery Companies turning to workforce management applications should consider both
More informationSharon Strause 9/10/2010. 15 years with the
Manage Software Development, Testing, and Validation Presented by Sharon Strause, Senior Consultant EduQuest, Inc. IVT s Computer and Software Validation EU Conference The Hilton Dublin Dublin, Ireland
More informationA CRO's Dilemma - The CDMS Validation Package that Failed Client Audits 19.OCT.2009 1. Disclaimer
A CRO's Dilemma - The CDMS Validation Package that Failed Client Audits Teri Stokes, Ph.D., Director GXP International Concord, MA - USA Common Sense Computer Validation 19.OCT.2009 1 Disclaimer The views
More informationBringing the Cloud into Focus. A Whitepaper by CMIT Solutions and Cadence Management Advisors
Bringing the Cloud into Focus A Whitepaper by CMIT Solutions and Cadence Management Advisors Table Of Contents Introduction: What is The Cloud?.............................. 1 The Cloud Benefits.......................................
More informationField 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 informationComputer System Validation - It s More Than Just Testing
Computer System Validation - It s More Than Just Testing Introduction Computer System Validation is the technical discipline that Life Science companies use to ensure that each Information Technology application
More informationTwo-Factor Authentication
WHITE PAPER: TWO-FACTOR AUTHENTICATION: A TCO VIEWPOINT........................................ Two-Factor Authentication Who should read this paper This whitepaper is directed at IT, Security, and Compliance
More informationEnterprise Key Management: A Strategic Approach ENTERPRISE KEY MANAGEMENT A SRATEGIC APPROACH. White Paper February 2010 www.alvandsolutions.
Enterprise Key Management: A Strategic Approach ENTERPRISE KEY MANAGEMENT A SRATEGIC APPROACH White Paper February 2010 www.alvandsolutions.com Overview Today s increasing security threats and regulatory
More informationWhat is Cloud-Based Security? Cloud-based Security = Security Management + Cloud Computing.
What is Cloud-Based Security? Cloud-based Security = Security Management + Cloud Computing. What is Cloud-Based Security? Cloud computing is: IT services via the internet from an external service provider
More informationRose Business Technologies
Benefits of Software as a Service (SaaS) Software as a Service (SaaS) may be defined simply as software applications deployed over the Internet. With SaaS, a third-party provider licenses an application
More informationAddress IT costs and streamline operations with IBM service desk and asset management.
Asset management and service desk solutions To support your IT objectives Address IT costs and streamline operations with IBM service desk and asset management. Highlights Help improve the value of IT
More informationHow to Avoid the Headache of User Mailbox Quotas
How to Avoid the Headache of User Mailbox Quotas Email Archiving Top Four Storage Management Challenges and Solutions Executive Summary Corporate email contains business critical information which is relied
More informationHow cloud computing can transform your business landscape
How cloud computing can transform your business landscape Introduction It seems like everyone is talking about the cloud. Cloud computing and cloud services are the new buzz words for what s really a not
More informationCLOUD ERP AND ACCOUNTING: SELECTION AND PLANNING GUIDE
CLOUD ERP AND ACCOUNTING: SELECTION AND PLANNING GUIDE Over the last three years, well over half of U.S. companies have elected to take advantage of one or more cloud-based solutions or services, but critical
More informationWhat is New Whitepaper. White Paper
Whitepaper This document previews the key features and enhancements in Microsoft Dynamics NAV 2013 R2. Contents are subject to change. Contents Introduction 3 Microsoft Dynamics NAV 2013 R2 in Office 365
More informationCloud-Testing vs. Testing a Cloud
Cloud- vs. a Cloud - 10th Annual International Software Conference 2010 Neha Mehrotra Abstract This white paper introduces Cloud computing business model which has been the natural evolution of the adoption
More informationSaaS Adoption Lifecycle in Life-Sciences Companies
www.arisglobal.com A White Paper Presented By ArisGlobal SaaS Adoption Lifecycle in Life-Sciences Companies by Achal Verma, Associate Director - Program Delivery, Cloud Services Abstract With increasing
More informationClinical Trials in the Cloud: A New Paradigm?
Marc Desgrousilliers CTO at Clinovo Clinical Trials in the Cloud: A New Paradigm? Marc Desgrousilliers CTO at Clinovo What is a Cloud? (1 of 3) "Cloud computing is a model for enabling convenient, on-demand
More informationComplete 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 informationBMC Control-M Workload Automation
solution overview BMC Control-M Workload Automation Accelerating Delivery of Digital Services with Workload Management Table of Contents 1 SUMMARY 2 FASTER AND CHEAPER DYNAMIC WORKLOAD MANAGEMENT Minimize
More informationIs a Cloud ERP Solution Right for You?
Is a Cloud ERP Solution Right for You? By Spencer Arnesen, CPA There s been a lot of hype recently about how cloud software solutions are the wave of the future. In the consumer environment, you can use
More informationGet Significant Application Quality Improvement without Major Investment Performance driven. Quality assured.
Testing Platform-as-a-Service Get Significant Application Quality Improvement without Major Investment Performance driven. Quality assured. Testing the way we do it Application testing can get expensive.
More informationCloud Infrastructure Services for Service Providers VERYX TECHNOLOGIES
Cloud Infrastructure Services for Service Providers VERYX TECHNOLOGIES Meeting the 7 Challenges in Testing and Performance Management Introduction With advent of the cloud paradigm, organizations are transitioning
More informationHow To Evaluate Saas And Cloud Solutions
Written in collaboration with SaaS Marketing Strategy Advisors Evaluating SaaS and Cloud Solutions: Effective Solution Overview Organizations of all sizes and across all industries have been rapidly adopting
More informationOECD 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 informationMOVING GRANTS MANAGEMENT TO THE CLOUD
MOVING GRANTS MANAGEMENT TO THE CLOUD A Vision for State and Local Government Decision-Makers December 2013 www.reisystems.com TABLE OF CONTENTS Introduction... 1 1. Unique State and Local Grants Management
More informationAchieve Economic Synergies by Managing Your Human Capital In The Cloud
Achieve Economic Synergies by Managing Your Human Capital In The Cloud By Orblogic, March 12, 2014 KEY POINTS TO CONSIDER C LOUD S OLUTIONS A RE P RACTICAL AND E ASY TO I MPLEMENT Time to market and rapid
More informationTHE EMERGING HR IMPERATIVE: Five Insights for Bridging the Training Effectiveness and Talent Management Gap
THE EMERGING HR IMPERATIVE: Five Insights for Bridging the Training Effectiveness and Talent Management Gap TALENT MANAGEMENT SOLUTIONS FOR LIFE SCIENCE COMPANIES IN THIS PAPER: How Life Science companies
More information8 Best Practices to Make Time and Attendance Easy
8 Best Practices to Make Time and Attendance Easy 8 BEST PRACTICES TO MAKE TIME AND ATTENDANCE EASY 2 Accurate time and attendance management is a vital enterprise function, and timely data is critical
More informationSaaS or On-Premise? How to Select the Right Paths for Your Enterprise. David Linthicum
SaaS or On-Premise? How to Select the Right Paths for Your Enterprise David Linthicum SaaS or On-Premise? How to Select the Right Paths for Your Enterprise 2 Executive Summary The growth of Software- as-
More informationCLOUD COMPUTING PROTECTION STRATEGIES
CLOUD COMPUTING PROTECTION STRATEGIES WHITE PAPER STRATEGIES FOR SaaS CONTINGENCY PLANNING CONTENTS Executive Summary What is Contingency Planning for SaaS Applications? The Crux of SaaS Enablement How
More information