CONTENTS. 1 Introduction 1
|
|
- Edwin Bell
- 8 years ago
- Views:
Transcription
1 Prelims 25/7/06 1:49 pm Page iii CONTENTS List of Tables List of Figures Preface Infrastructure Lifecycle Approach Recommendation and Conceptualization Design Design Reviews Development and Integration Implementation Release for Use Operational Life Retirement Retaining Project and Qualification-Related Deliverables Chapter 2 Summary 3 Infrastructure Qualification Overview What is Infrastructure? What is Infrastructure Qualification? Why Qualify the Computer Infrastructure? to the Infrastructure Qualification Process All Together 4 FDA Enforcement FDA Computer Systems Enforcement Ganes Chemicals ( ) Eli Lilly & Company ( ) iii
2 Prelims 25/7/06 1:49 pm Page iv iv Infrastructure Qualification in the FDA Regulated Industry Pharmacia Corporation ( and Warning Letter 2001) Novartis Pharma GmbH ( ) Skele Tech ( ) Company Unknown ( ) Company Unknown (Warning Letter 2004) International Pharm & Biotech Labs (EIR June 2003) 5 Regulatory Requirements Potential Regulatory Consequences US FDA Regulatory Requirements EU Regulatory Guidance 6 21 CFR Part 11 LAN/WAN Server Hardware and Service Components System-level Software 7 Procedural Controls 8 Computer Infrastructure Security Physical Security Network Security Other Key Security Elements OSI Model Security Services Authentication Protection of Records and Audit Trails Protection of Records Audit Trails 9 Infrastructure Qualification Planning Qualification Project Plan Project Schedule 10 Qualification Testing Qualification Testing Lifecycle Test Plan Protocol Summary (Analysis) Report Commissioning Sample Qualification Testing/Commissioning Test Cases System-level Software Application Servers Service Components LAN/WAN
3 Prelims 25/7/06 1:49 pm Page v Contents v Miscellaneous Equipment Network Centers 11 Qualification Testing System-level Software Server and Controllers Operating Systems Qualification Testing Practices for Operating Systems Part 11 Areas of Interest Network Operating Systems Qualification Testing Practices for Operating Systems Qualification Testing Practices for Firmware Part 11 Areas of Interest Security, Diagnostic and Monitoring Tools Qualification Testing Practices for Standard Software Packages Part 11 Areas of Interest Desktop Images Scripts Qualification Testing Practices for Scripts Part 11 Areas of Interest File and Database Management Middleware Part 11 Areas of Interest 12 Qualification Testing Application Servers and Service Components Installation Qualification Operational Qualification 13 Qualification Testing LAN Devices Switch Router Qualification of Other LAN Devices Hub Gateways Repeaters Bridges Brouter 14 Qualification Testing WAN Devices External Router WAN Links Firewall VPN Switches Load Balancing Devices Intrusion Detection Devices 15 Qualification Testing WAN/LAN System
4 Prelims 25/7/06 1:49 pm Page vi vi Infrastructure Qualification in the FDA Regulated Industry 16 Qualification Testing the Storage Area Networks Qualification Strategy Part Qualification Wireless Services WLAN Devices Access Point VPN Server LAN Switch WLAN System Qualification 18 Qualification Testing Network Centers Qualification Testing Installation Qualification Operational Qualification 19 Qualification Testing Database Manager Database Server Single or Cluster Database Server Software Critical Database Server Issues Part 11 Considerations Qualification Testing 20 Change Management Type of Change Change Management Process Emergency Changes Part 11 and Infrastructure Related Change 21 Training 22 Remediation Project Infrastructure Evaluation Corrective Action Planning Interpretation Impact Assessment Training Suppliers Qualification Program Remediation Remediation Project Report 23 Maintaining the State of Qualification
5 Prelims 25/7/06 1:49 pm Page vii Contents vii Security Operational Management Operational Network Management Business Continuity Problem Reporting Control of Changes Periodic Review Retirement On-going Verification Program Appendix A Appendix B Appendix C Appendix D Appendix E Appendix F Appendix G Appendix H Appendix I Appendix J Glossary of Terms Abbreviations and/or Acronyms Infrastructure Basics Compliance Policy Guides Documentation: Brief Description OSI and TCP/IP Network Models References Qualification of Computer Networks Words Signifying the Requirements in Specification Case Study: A Network Upgrade Index
6 Prelims 25/7/06 1:49 pm Page viii
7 Prelims 25/7/06 1:49 pm Page ix LIST OF TABLES 5.1 cgmps Regulations Application to Computer Systems 5.2 Comparison GMPs, EU Annex 11 and Part Part 11 Security Related Requirements/Controls 12.1 Category of Servers 23.1 Period/Events Computer Systems Operational Life H1 NEED CAPTION ix
8 Prelims 25/7/06 1:49 pm Page x
9 Prelims 25/7/06 1:49 pm Page xi LIST OF FIGURES 2.1 Infrastructure Qualification Lifecycle 2.2 Conceptualization 2.3 Design Evaluation Cycle 2.4 Design 2.5 Design Reviews 2.6 Development and Integration 2.7 Implementation 2.8 Release for Use 2.9 Operational Life 3.1 A Computer System and the Operating Environment 3.2 Application/Infrastructure Development and Installation Correlation 8.1 Security Issues to Consider 8.2 Security Services Provided by OSI Layers 8.3 SSL 3.0 Protocol 9.1 Systems Development Distribution 11.1 OSI and the TCP/IP Reference Models 17.1 NEED CAPTION 22.1 Complete Part 11 Remediation Project FI The Seven Layers of OSI F2 Comparison between OSI and TCP/IP Models H1 System Block Diagram J1 Previous Hub and Spoke Technology J2 New Ring Technology J3 Project Plan Table of Contents J4 Sample Installation Checklist xi
10 Prelims 25/7/06 1:49 pm Page xii
11 Prelims 25/7/06 1:49 pm Page xiii PREFACE The need to validate computerised systems supporting the development, manufacture, and supply of medicinal products is well understood. The validation of applications has been the primary focus and quite rightly too with the impact these systems can have on the quality, safety and efficacy of drug products. Now however with modern IT solutions there is a growing dependency on robust and secure infrastructure [1,2]. Deficiencies in the IT infrastructure (eg virus protection, persoßnal identity authentication, password management, and electronic records management) will compromise the validate status of computerised systems. It is important therefore that IT infrastructure is developed and maintained to support the regulatory compliance of the applications they support. Desktop configuration, networks design and management, and the use of internet/intranet/extranets are just some of the topics that need to be addressed. It is important to appreciate that IT infrastructure has its own special character. It is more organic than computer applications in the sense that it grows and evolves to meet the changing needs of the multitude of applications being supported. It cannot be thought of as a discrete element like an individual computer application. This is often reflected by the organisation of the IT department responsible for IT infrastructure. A different approach and procedures is required. Regulatory authorities have made numerous citations for what they consider noncompliant IT infrastructure [2]. Regulatory expectations for IT infrastructure however are not explicitly defined although some regulatory guidance does exist [3]. ISPE/GAMP has been working on the topic of IT infrastructure for many years to clarify requirements and has developed some guidance material [4]. PDA has also developed some guidance material [5]. The definition of requirements to date however largely presents principles rather than a working manual for compliance. The management and controls for IT infrastructure must always be cognisant of the relative risk posed to patients. IT infrastructure will normally be considered as having an indirect impact on patient safety. Consequently IT infrastructure does not normally require the same validation approach adopted for computerised systems with a direct impact on patient xiii
12 Prelims 25/7/06 1:49 pm Page xiv xiv Infrastructure Qualification in the FDA Regulated Industry safety. This is not to undermine the key role infrastructure plays to assuring the reliable operation and record integrity required by applications. However care must be taken not to inadvertently over-engineer solutions on the basis of perceived regulatory compliance. What ever is done needs to be done on the basis of tangible benefits. This book presents some of the latest thinking on how to tackle what can often be quite daunting questions on how to assure IT infrastructure for regulatory compliance. Orlando Lopez gives clear direction on how to approach IT Infrastructure based on personal experience and industry discussions. The principles behind the guidance given in this book are consistent with the latest edition of the GAMP4 Guide [6]. Lopez takes these principles into practice with a working level of detail that will be welcomed by practitioners. Inexperienced and experienced practitioners alike will find valuable insights into how best to address IT Infrastructure. References [1] Wingate, G.A.S. (2000) Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers, Interpharm Press. [2] Wingate, G.A.S. (2004) Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance for Pharmaceutical and Healthcare Companies Interpharm Press. [3] Pharmaceutical Inspection Co-operation Scheme (2005) Good Practices for Computerised Systems in Regulated GxP Environments, Pharmaceutical Inspection Convention, PI 011-1, Geneva. [4] GAMP Forum (2004) GAMP Good Practice Guide for IT Infrastructure Control and Compliance, published by International Society for Pharmaceutical Engineering ( [5] Crosson, J.E., Campbell, M.W., Noonan, T. (2000) Network Management in an FDA- Regulated Environment, PDA Journal of Pharmaceutical Science and Technology. [6] GAMP Forum (2001) GAMP Guide for Validation of Automated Systems (known as GAMP4), published by International Society for Pharmaceutical Engineering (
The FDA recently announced a significant
This article illustrates the risk analysis guidance discussed in GAMP 4. 5 By applying GAMP s risk analysis method to three generic classes of software systems, this article acts as both an introduction
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 informationBack to index of articles. Qualification of Computer Networks and Infrastructure
Back to index of articles Qualification of Computer Networks and Infrastructure R.D.McDowall McDowall Consulting Validation of computerised systems generally focuses on the providing documented evidence
More informationNOS for Network Support (903)
NOS for Network Support (903) November 2014 V1.1 NOS Reference ESKITP903301 ESKITP903401 ESKITP903501 ESKITP903601 NOS Title Assist with Installation, Implementation and Handover of Network Infrastructure
More informationIP Telephony Management
IP Telephony Management How Cisco IT Manages Global IP Telephony A Cisco on Cisco Case Study: Inside Cisco IT 1 Overview Challenge Design, implement, and maintain a highly available, reliable, and resilient
More informationThis interpretation of the revised Annex
Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE July/August 2011, Vol. 31 No. 4 www.ispe.org Copyright ISPE 2011 The ISPE GAMP Community of Practice (COP) provides its interpretation
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 informationNetwork Qualification: What Is it; What Does it Involve?
JVT_May2007.qxd 4/23/07 8:04 AM Page 210 Network Qualification: What Is it; What Does it Involve? BY ESRA GUVEN, B.Sc.EE, PMP, CCNA WHAT IS A NETWORK? The Food and Drug Administration (FDA) defines a network
More informationData Network Security Policy
Authors: Mike Smith Rod Makosch Network Manager Data Security Officer IM&T IM&T Version No : 1 Approval Date: March 2005 Approved by : John Aird Director of IM&T Review Date : 1 April 2006 Trust Ref: C7/2005
More informationGOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 011-3 25 September 2007 PIC/S GUIDANCE GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS PIC/S
More informationClinical database/ecrf validation: effective processes and procedures
TITOLO SLIDE Testo Slide Testo Slide Testo Slide Clinical database/ecrf validation: effective processes and procedures IV BIAS ANNUAL CONGRESS Padova September, 26 th 2012 PQE WORKSHOP: What's new in Computerized
More informationExternal Supplier Control Requirements
External Supplier Control s Cyber Security For Suppliers Categorised as Low Cyber Risk 1. Asset Protection and System Configuration Barclays Data and the assets or systems storing or processing it must
More informationComputerized System Audits In A GCP Pharmaceutical Laboratory Environment
IVTGXP_july06.qxd 6/28/06 1:09 PM Page 36 Computerized System Audits In A GCP Pharmaceutical Laboratory Environment By Maintaining data integrity for both clinical laboratory processes and patient data
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 informationCOTS Validation Post FDA & Other Regulations
COTS Validation Post FDA & Other Regulations TABLE OF CONTENTS 1. Abstract 3 2. What is COTS 3 3. Why should COTS require Validation? 3 4. Risk Based Approach 4 5. Validation Approach 6 6. Applicable Regulations
More informationCOURSE NUMBER: CTS 2371
Form 2A, Page 1 FLORIDA STATE COLLEGE AT JACKSONVILLE COLLEGE CREDIT COURSE OUTLINE COURSE NUMBER: CTS 2371 COURSE TITLE: Virtual Infrastructure: Deployment, Security, and Analysis PREREQUISITE(S): CTS
More informationINCIDENT RESPONSE CHECKLIST
INCIDENT RESPONSE CHECKLIST The purpose of this checklist is to provide clients of Kivu Consulting, Inc. with guidance in the initial stages of an actual or possible data breach. Clients are encouraged
More informationCisco Advanced Services for Network Security
Data Sheet Cisco Advanced Services for Network Security IP Communications networking the convergence of data, voice, and video onto a single network offers opportunities for reducing communication costs
More informationNetwork Security Policy
Network Security Policy Policy Contents I. POLICY STATEMENT II. REASON FOR POLICY III. SCOPE IV. AUDIENCE V. POLICY TEXT VI. PROCEDURES VII. RELATED INFORMATION VIII. DEFINITIONS IX. FREQUENTLY ASKED QUESTIONS
More informationWhat is the correct title of this publication? What is the current status of understanding and implementation?
GMP Rules and Guidelines in 2013 for Computer System Validation / Computerises Systems / Electronic Records and Signatures/ IT Infrastructure and Application Compliance: What is the correct title of this
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 informationFirewall. Vyatta System. REFERENCE GUIDE IPv4 Firewall IPv6 Firewall Zone Based Firewall VYATTA, INC.
VYATTA, INC. Vyatta System Firewall REFERENCE GUIDE IPv4 Firewall IPv6 Firewall Zone Based Firewall Vyatta Suite 200 1301 Shoreway Road Belmont, CA 94002 vyatta.com 650 413 7200 1 888 VYATTA 1 (US and
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 informationFirewall. Vyatta System. REFERENCE GUIDE IPv4 Firewall IPv6 Firewall Zone Based Firewall VYATTA, INC.
VYATTA, INC. Vyatta System Firewall REFERENCE GUIDE IPv4 Firewall IPv6 Firewall Zone Based Firewall Vyatta Suite 200 1301 Shoreway Road Belmont, CA 94002 vyatta.com 650 413 7200 1 888 VYATTA 1 (US and
More informationGuidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application
Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research
More information"Charting the Course... ... to Your Success!" MOC 50331 D Windows 7 Enterprise Desktop Support Technician Course Summary
Description Course Summary This course provides students with the knowledge and skills needed to isolate, document and resolve problems on a Windows 7 desktop or laptop computer. It will also help test
More informationExternal Supplier Control Requirements
External Supplier Control Requirements Cyber Security For Suppliers Categorised as High Cyber Risk Cyber Security Requirement Description Why this is important 1. Asset Protection and System Configuration
More informationOCR LEVEL 3 CAMBRIDGE TECHNICAL
Cambridge TECHNICALS OCR LEVEL 3 CAMBRIDGE TECHNICAL CERTIFICATE/DIPLOMA IN IT COMPUTER NETWORKS R/601/7320 LEVEL 3 UNIT 7 GUIDED LEARNING HOURS: 60 UNIT CREDIT VALUE: 10 COMPUTER NETWORKS R/601/7320 LEVEL
More informationQUESTIONS FOR YOUR SOFTWARE VENDOR: TO ASK BEFORE YOUR AUDIT
QUESTIONS FOR YOUR SOFTWARE VENDOR: TO ASK BEFORE YOUR AUDIT Heather Longden Senior Marketing Manager Waters Corporation Boston Chapter Educational Meeting June 2016 About Waters Lab Informatics Separations
More informationInformation Security Assessment and Testing Services RFQ # 28873 Questions and Answers September 8, 2014
QUESTIONS ANSWERS Q1 How many locations and can all locations be tested from a A1 5 locations and not all tests can be performed from a central location? central location. Q2 Connection type between location
More informationNetworking. Sixth Edition. A Beginner's Guide BRUCE HALLBERG
Networking A Beginner's Guide Sixth Edition BRUCE HALLBERG Mc Graw Hill Education New York Chicago San Francisco Athens London Madrid Mexico City Milan New Delhi Singapore Sydney Toronto Contents Acknowledgments
More informationSchneps, Leila; Colmez, Coralie. Math on Trial : How Numbers Get Used and Abused in the Courtroom. New York, NY, USA: Basic Books, 2013. p i.
New York, NY, USA: Basic Books, 2013. p i. http://site.ebrary.com/lib/mcgill/doc?id=10665296&ppg=2 New York, NY, USA: Basic Books, 2013. p ii. http://site.ebrary.com/lib/mcgill/doc?id=10665296&ppg=3 New
More informationFLORIDA STATE COLLEGE AT JACKSONVILLE COLLEGE CREDIT COURSE OUTLINE
Form 2A, Page 1 FLORIDA STATE COLLEGE AT JACKSONVILLE COLLEGE CREDIT COURSE OUTLINE COURSE NUMBER: CET 2600 COURSE TITLE: Network Fundamentals PREREQUISITE(S): CTS 1131 and CTS 1133 COREQUISITE(S): STUDENT
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 informationEclipsys Sunrise Clinical Manager Enterprise Electronic Medical Record (SCM) and Title 21 Code of Federal Regulations Part 11 (21CFR11)
Eclipsys Sunrise Clinical Manager Enterprise Electronic Medical Record (SCM) and Title 21 Code of Federal Regulations Part 11 (21CFR11) The title 21 code of federal regulations part 11 deals with an institutions
More informationNetwork System Design Lesson Objectives
Network System Design Lesson Unit 1: INTRODUCTION TO NETWORK DESIGN Assignment Customer Needs and Goals Identify the purpose and parts of a good customer needs report. Gather information to identify network
More informationState of Illinois Department of Central Management Services GENERAL SECURITY FOR STATEWIDE NETWORK RESOURCES POLICY
State of Illinois Department of Central Management Services GENERAL SECURITY FOR STATEWIDE NETWORK RESOURCES POLICY Effective December 15, 2008 State of Illinois Department of Central Management Services
More informationUnderstanding the Pros and Cons of Combination Networks 7. Acknowledgments Introduction. Establishing the Numbers of Clients and Servers 4
Mac OS X System Administration GUY HART-DAVIS Mc Graw Hill New York Chicago San Francisco Lisbon London Madrid Mexico City Milan New Delhi San Juan Seoul Singapore Sydney Toronto Acknowledgments Introduction,
More informationICAB5238B Build a highly secure firewall
ICAB5238B Build a highly secure firewall Release: 1 ICAB5238B Build a highly secure firewall Modification History Not Applicable Unit Descriptor Unit descriptor This unit defines the competency required
More informationRegulated Applications in the Cloud
Keith Williams CEO Regulated Applications in the Cloud Aspects of Security and Validation Statement on the Cloud and Pharma s added Complexity Clouds already make sense for many small and mediumsize businesses,
More informationNZQA Expiring unit standard 6857 version 4 Page 1 of 5. Demonstrate an understanding of local and wide area computer networks
Page 1 of 5 Title Demonstrate an understanding of local and wide area computer networks Level 7 Credits 10 Purpose People credited with this unit standard are able to: describe network types and standards;
More informationScope of Work Microsoft Infrastructure Upgrade
Introduction Scope of Work Microsoft Infrastructure Upgrade The University of Texas M. D. Anderson Cancer Center (M. D. Anderson) in Houston, Texas, celebrating six decades of Making Cancer History, is
More informationFDA Software Validation-Answers to the Top Five Software Validation Questions
Whitepaper FDA Software Validation-Answers to the Top Five Software Validation Questions Author: Penny Goss, Penny Goss Technical Solutions The FDA (Food and Drug Administration) and IEC (International
More informationNetwork Security. Tampere Seminar 23rd October 2008. Overview Switch Security Firewalls Conclusion
Network Security Tampere Seminar 23rd October 2008 1 Copyright 2008 Hirschmann 2008 Hirschmann Automation and and Control GmbH. Contents Overview Switch Security Firewalls Conclusion 2 Copyright 2008 Hirschmann
More informationLOGIIC Remote Access. Final Public Report. June 2015 1 LOGIIC - APPROVED FOR PUBLIC DISTRIBUTION
LOGIIC Remote Access June 2015 Final Public Report Document Title LOGIIC Remote Monitoring Project Public Report Version Version 1.0 Primary Author A. McIntyre (SRI) Distribution Category LOGIIC Approved
More informationFundamentals of a Windows Server Infrastructure MOC 10967
Fundamentals of a Windows Server Infrastructure MOC 10967 Course Outline Module 1: Installing and Configuring Windows Server 2012 This module explains how the Windows Server 2012 editions, installation
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 informationGuidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS
Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS U.S. Department of Health and Human Services Food and Drug Administration Center for Biologic Evaluation and Research (CBER) Center for
More informationPCI Compliance - A Realistic Approach. Harshul Joshi, CISM, CISA, CISSP Director, Information Technology CBIZ MHM hjoshi@cbiz.com
PCI Compliance - A Realistic Approach Harshul Joshi, CISM, CISA, CISSP Director, Information Technology CBIZ MHM hjoshi@cbiz.com What What is PCI A global forum launched in September 2006 for ongoing enhancement
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 information"Charting the Course... Implementing Citrix NetScaler 11 for App and Desktop Solutions CNS-207 Course Summary
Course Summary Description The objective of this course is to provide the foundational concepts and teach the skills necessary to implement, configure, secure and monitor a Citrix NetScaler system with
More informationPRINCIPLES AND PRACTICE OF INFORMATION SECURITY
PRINCIPLES AND PRACTICE OF INFORMATION SECURITY Protecting Computers from Hackers and Lawyers Linda Volonino, Ph.D. Canisius College Stephen R. Robinson Verity Partners, LLC with contributions by Charles
More informationInstalling Globodox Web Client on Windows Server 2012
Installing Globodox Web Client on Windows Server 2012 Make sure that the Globodox Desktop Client is installed. Make sure it is not running. Note: Please click on Allow or Continue for all required UAC
More informationIn 2001, ISPE issued Baseline Guide Volume
In today s biopharma and pharmaceutical industries, three related, but distinct terms are in common use: commissioning, qualification, and verification. Inconsistent interpretation and application of these
More informationGRADUATE REGISTERED PHYSICIANS
REGULATION 37 GRADUATE REGISTERED PHYSICIANS Act 929 of 2015 codified in A.C.A. 17-95-901-917 ARKANSAS GRADUATE REGISTERED PHYSICIAN ACT I. Definitions. A. Graduate registered physician means an individual
More informationGUIDE TO INFORMATION SECURITY TESTING AND ASSESSMENT
GUIDE TO INFORMATION SECURITY TESTING AND ASSESSMENT Shirley Radack, Editor Computer Security Division Information Technology Laboratory National Institute of Standards and Technology A comprehensive approach
More informationWHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE
WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE White paper produced by Maetrics For more information, please contact global sales +1 610 458 9312 +1 877 623 8742 globalsales@maetrics.com
More informationIndustrial Network Security for SCADA, Automation, Process Control and PLC Systems. Contents. 1 An Introduction to Industrial Network Security 1
Industrial Network Security for SCADA, Automation, Process Control and PLC Systems Contents 1 An Introduction to Industrial Network Security 1 1.1 Course overview 1 1.2 The evolution of networking 1 1.3
More informationTraining Course Computerized System Validation in the Pharmaceutical Industry Istanbul, 16-17 January 2003. Change Control
Training Course Computerized System Validation in the Pharmaceutical Industry Istanbul, 16-17 January 2003 Change Control Wolfgang Schumacher Roche Pharmaceuticals, Basel Agenda Change Control Definitions
More informationSTRATEGIC POLICY. Information Security Policy Documentation. Network Management Policy. 1. Introduction
Policy: Title: Status: 1. Introduction ISP-S12 Network Management Policy Revised Information Security Policy Documentation STRATEGIC POLICY 1.1. This information security policy document covers management,
More informationFirewall REFERENCE GUIDE. VYATTA, INC. Vyatta System. IPv4 Firewall IPv6 Firewall Zone-Based Firewall. Title
Title VYATTA, INC. Vyatta System Firewall REFERENCE GUIDE IPv4 Firewall IPv6 Firewall Zone-Based Firewall Vyatta Suite 200 1301 Shoreway Road Belmont, CA 94002 vyatta.com 650 413 7200 1 888 VYATTA 1 (US
More informationGAMP 5 as a Suitable Framework for Validation of Electronic Document Management Systems On Premise and 'In the Cloud' Keith Williams CEO GxPi
GAMP 5 as a Suitable Framework for Validation of Electronic Document Management Systems On Premise and 'In the Cloud' Keith Williams CEO GxPi Disclaimer The views and opinions expressed in the following
More informationHOSTEDMIDEX.CO.UK. Additional services are also available according to Client specific plan configuration.
HOSTEDMIDEX.CO.UK THIS SERVICE LEVEL AGREEMENT (SLA) DEFINES GUARANTEED SERVICE LEVELS PROVIDED TO CLIENT BY THE SUPPLIER. I. Service Definition Lanmark Technical Services Ltd trading as mailhosted.co.uk
More informationGAMP 4 to GAMP 5 Summary
GAMP 4 to GAMP 5 Summary Introduction This document provides summary information on the GAMP 5 Guide and provides a mapping to the previous version, GAMP 4. It specifically provides: 1. Summary of Need
More informationLab 9.1.1 Organizing CCENT Objectives by OSI Layer
Lab 9.1.1 Organizing CCENT Objectives by OSI Layer Objectives Organize the CCENT objectives by which layer or layers they address. Background / Preparation In this lab, you associate the objectives of
More informationEA-ISP-012-Network Management Policy
Technology & Information Services EA-ISP-012-Network Management Policy Owner: Adrian Hollister Author: Paul Ferrier Date: 01/04/2015 Document Security Level: PUBLIC Document Version: 1.00 Document Ref:
More informationADM:49 DPS POLICY MANUAL Page 1 of 5
DEPARTMENT OF PUBLIC SAFETY POLICIES & PROCEDURES SUBJECT: IT OPERATIONS MANAGEMENT POLICY NUMBER EFFECTIVE DATE: 09/09/2008 ADM: 49 REVISION NO: ORIGINAL ORIGINAL ISSUED ON: 09/09/2008 1.0 PURPOSE The
More informationIT Security in Process Automation - Top Ten
IT Security for Process Control Field Devices, Services and Maintenance INTERKAMA Forum, April 13 th, 2005 Slide 1 IT Security in Process Automation Content Why is this important? Security Measures in
More informationOracle Procurement. Punchout and Transparent Punchout Guide for Oracle iprocurement and Oracle Exchange Release 11i. Part No.
Oracle Procurement Punchout and Transparent Punchout Guide for Oracle iprocurement and Oracle Exchange Release 11i Part No. A92190-03 April 2003 Oracle Procurement Punchout and Transparent Punchout Guide
More informationIT Audit and Compliance
Problem IT Audit and Compliance IT audit is about the formal verification and validation of the quality and effectiveness of IT controls to support the overall business control objectives. From a security
More informationAntivirus and Malware Prevention Policy and Procedures (Template) Employee Personal Device Use Terms and Conditions (Template)
Below you will find the following sample policies: Antivirus and Malware Prevention Policy and Procedures (Template) Employee Personal Device Use Terms and Conditions (Template) *Log in to erisk Hub for
More informationRisk-Based Approach to 21 CFR Part 11
3109 W. Dr. Martin Luther King, Jr. Blvd., Suite 250 Tampa, FL 33607 USA Tel: 813/960-2105 Fax: 813/264-2816 www.ispe.org Risk-Based Approach to 21 CFR Part 11 The 21 CFR Part 11 regulation is a comprehensive
More informationICANWK406A Install, configure and test network security
ICANWK406A Install, configure and test network security Release: 1 ICANWK406A Install, configure and test network security Modification History Release Release 1 Comments This Unit first released with
More informationInformation Technology Security Guideline. Network Security Zoning
Information Technology Security Guideline Network Security Zoning Design Considerations for Placement of s within Zones ITSG-38 This page intentionally left blank. Foreword The Network Security Zoning
More informationSolutions for Health Insurance Portability and Accountability Act (HIPAA) Compliance
White Paper Solutions for Health Insurance Portability and Accountability Act (HIPAA) Compliance Troy Herrera Sr. Field Solutions Manager Juniper Networks, Inc. 1194 North Mathilda Avenue Sunnyvale, CA
More informationPolicies and Procedures
Policies and Procedures Provided by PROGuard The following are policies and procedures which need to be enforced to ensure PCI DSS compliance. In order to answer yes to the questions and pass the SAQ,
More informationINTRODUCTION. 1.1 The Need for Guidance on ERP System Validation
Chapter1 13/3/06 8:38 pm Page 1 1 INTRODUCTION 1.1 The Need for Guidance on ERP System Validation There are numerous books that address the topic of computer systems validation in the regulated life sciences
More informationFDA Releases Final Cybersecurity Guidance for Medical Devices
FDA Releases Final Cybersecurity Guidance for Medical Devices By Jean Marie R. Pechette and Ken Briggs Overview and General Principles On October 2, 2014, the Food and Drug Administration ( FDA ) finalized
More informationB1 Project Management 100
Assignment of points B1 Project Management 100 Requirements for Design Presentation Meetings and Proposal Submissions for Key to Project Management Design Presentation Meeting and Proposal Submissions
More informationWORKSTATION MANAGEMENT STANDARD PROCEDURES
OFFICE OF THE VICE PRESIDENT FOR INFORMATION TECHNOLOGY POST OFFICE BOX 8122 STATESBORO, GEORGIA 30460-8122 TELEPHONE (912) 478-1294 FAX (912) 478-7720 WORKSTATION MANAGEMENT STANDARD PROCEDURES I. Authorization
More informationBest Practices for PCI DSS V3.0 Network Security Compliance
Best Practices for PCI DSS V3.0 Network Security Compliance January 2015 www.tufin.com Table of Contents Preparing for PCI DSS V3.0 Audit... 3 Protecting Cardholder Data with PCI DSS... 3 Complying with
More informationNetworking. Systems Design and. Development. CRC Press. Taylor & Francis Croup. Boca Raton London New York. CRC Press is an imprint of the
Networking Systems Design and Development Lee Chao CRC Press Taylor & Francis Croup Boca Raton London New York CRC Press is an imprint of the Taylor & Francis Croup, an Informa business AN AUERBACH BOOK
More informationKings Regional Occupational Program Course Information
Kings County Board of Education Approval May 4, 2011 California Department of Education Certification August 22, 2007 Kings Regional Occupational Program Course Information Course Title: Cisco Discovery:
More informationUnited States Trustee Program s Wireless LAN Security Checklist
United States Trustee Program s Wireless LAN Security Checklist In support of a standing trustee s proposed implementation of Wireless Access Points (WAP) in ' 341 meeting rooms and courtrooms, the following
More informationComputerised Systems. Seeing the Wood from the Trees
Computerised Systems Seeing the Wood from the Trees Scope WHAT IS A COMPUTERISED SYSTEM? WHY DO WE NEED VALIDATED SYSTEMS? WHAT NEEDS VALIDATING? HOW DO WE PERFORM CSV? WHO DOES WHAT? IT S VALIDATED -
More informationWhen to Upgrade: Balancing Benefits of New Systems with Costs to Upgrade
When to Upgrade: Balancing Benefits of New Systems with Costs to Upgrade 800.982.2388 1 Introduction The decision on when to upgrade computer systems, such as calibration and maintenance management systems,
More information21 CFR Part 11 Deployment Guide for Wonderware System Platform 3.1, InTouch 10.1 and Historian 9.0
Deployment Guide 21 CFR Part 11 Deployment Guide for Authors: Invensys Operations Management and TSD (Total System Design, an Optimation Company) Table of Contents by Section 1 Before you Begin...............................................................................................
More informationOMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT
OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT PA/PH/OMCL (08) 69 3R Full document title and reference Document type VALIDATION OF COMPUTERISED SYSTEMS Legislative basis - CORE DOCUMENT
More informationNetwork Security Guidelines. e-governance
Network Security Guidelines for e-governance Draft DEPARTMENT OF ELECTRONICS AND INFORMATION TECHNOLOGY Ministry of Communication and Information Technology, Government of India. Document Control S/L Type
More informationTechnical Notes TN 1 - ETG 3000. FactoryCast Gateway TSX ETG 3021 / 3022 modules. How to Setup a GPRS Connection?
FactoryCast Gateway TSX ETG 3021 / 3022 modules How to Setup a GPRS Connection? 1 2 Table of Contents 1- GPRS Overview... 4 Introduction... 4 GPRS overview... 4 GPRS communications... 4 GPRS connections...
More informationThis is a preview - click here to buy the full publication
TECHNICAL REPORT IEC/TR 62443-3-1 Edition 1.0 2009-07 colour inside Industrial communication networks Network and system security Part 3 1: Security technologies for industrial automation and control systems
More informationVolume 11 Number 4 July 2007
Volume 11 Number 4 July 2007 Process Transformation for Better IT Service Delivery in the Pharmaceutical Industry By Kamal Biswas A change management process helps users adopt the system and be part of
More informationCourse Outline. ttttttt
10967 - Fundamentals of a Windows Server Infrastructure General Description Learn the fundamental knowledge and skills that you need to build a Windows Server infrastructure with Windows Server 2012. This
More informationInternational Trade Administration
U.S. DEPARTMENT OF COMMERCE Office of Inspector General International Trade Administration FY 2007 FISMA Assessment of Core Network General Support System (ITA-012) Final Inspection Report No. OSE-18840/September
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 information15 Organisation/ICT/02/01/15 Back- up
15 Organisation/ICT/02/01/15 Back- up 15.1 Description Backup is a copy of a program or file that is stored separately from the original. These duplicated copies of data on different storage media or additional
More informationSecurity Frameworks. An Enterprise Approach to Security. Robert Belka Frazier, CISSP belka@att.net
Security Frameworks An Enterprise Approach to Security Robert Belka Frazier, CISSP belka@att.net Security Security is recognized as essential to protect vital processes and the systems that provide those
More informationSonicWALL Secure Wireless Network
SONICWALL Ä SonicWALL Secure Wireless Network Integrated Solutions Guide ^ Official guide from SonicWALL Written by SonicWALL engineers and documentation specialists Appropriate for all audiences, from
More informationPCI Solution for Retail: Addressing Compliance and Security Best Practices
PCI Solution for Retail: Addressing Compliance and Security Best Practices Executive Summary The Payment Card Industry (PCI) Data Security Standard has been revised to address an evolving risk environment
More informationREMOTE ACCESS POLICY OCIO-6005-09 TABLE OF CONTENTS
OFFICE OF THE CHIEF INFORMATION OFFICER REMOTE ACCESS POLICY OCIO-6005-09 Date of Issuance: May 22, 2009 Effective Date: May 22, 2009 Review Date: TABLE OF CONTENTS Section I. PURPOSE II. AUTHORITY III.
More information