Progress zenon projects to FDA 21 CFR Part 11 compliance
|
|
- Calvin Collins
- 7 years ago
- Views:
Transcription
1 Progress zenon projects to FDA 21 CFR Part 11 compliance
2 History Date Comment Robert Harrison, original author 2
3 Contents History... 2 Contents Introduction Objective User administration Users User groups Active Directory Biometric logon Project properties User administration at runtime Audit-trail Process variables Dynamic elements CEL logging Alarm logging CEL & Alarm archiving Project wide activity Function authorizations History of changes Runtime changeable data Check list
4 1. Introduction The regulation process requires the manufacturer of a regulated product to prove and document that a product meets all claims related to its performance. Regulations provide the measure of security that the manufacturing process is controlled to meet all quality and design specifications. The data required must prove that the equipment, material and processes used in the manufacture will produce the same results each time this product is produced. Pharmaceutical and other regulated industries prior to the advent of Part 11 had paperbased systems for recording regulated processes. The FDA 21 CFR Part 11 outlines the use of electronic records and electronic signatures in this environment, it defines the criteria for electronic records and signatures to be trustworthy, reliable and considered equivalent to paper based signatures. The collection of electronic data must adhere to the strict guidlines, electronic signatures must be linked to the electronics records, all activity must be recorded in an audit-trail, security mearsures must be in place to restrict access to systems in the regulated environment. Software products themselves cannot be certified or validated, only the end product or project of the regulated company can be validated. zenon offers the functionalities to enable project designers to create a validated project. 2. Objective zenon has the integral functionality to adhere to FDA 21 CFR Part 11 regulations. The use of integral functionality has a significant advantage in that all projects can be configured at any stage to be compliant. The process of evolving a project to be compliant is a simple matter of selecting options to activate User administration, Audittrail, Authorizations, and Alarm management. User administration regulates who can have access to this closed system, restricting usage to authorized personnel through an username & password verification. Password aging must enforced, with unsuccessful login attempts being recorded and forcing system lockouts when unauthorized access is requested. Each operation, event, and critical exception must be documented, recording who, what, why, where and when information. Through the audit-trail it must be possible to reconstruct the complete history of events and processes. The functionality within a project must be restricted to certain users, using authorization to limit activity, and force a certain workflow of operations. Authorization levels on dynamic elements permit which operations can be performed. Each process variable must have the possibility to have alarm limits attributed. The alarm limits reflect critical process exceptions, general alarms & warnings. 4
5 3. User administration To access a closed system a user must be authorized by providing a username & password with a valid account. In zenon different methods are supported to achieve this; zenon has local user administration, where users are established in both the editor and run time. The user can be attributed authorization levels directly, and/or be attributed a User group, where authorization levels have previously been defined to groups organized by functionality. Windows Active Director (includes ADAM & AD LDS) can also be established, where user accounts can be managed centrally. Active Directory works in tandem with local zenon accounts, when logging in Active Directory is first checked, if the user exists the user is logged in, if the user doesn t exist in the Active Directory account local accounts in the zenon project are checked. Local zenon User accounts can be administred in the editor and in the run-time. In the editor the creating of User and User Groups is achieved under the item User administration in the Project Manager. 3.1 Users Under Project properties User administration User a new account can be created. Each user must enter a username, a full name, and a password. Here the administrator privildeges can be applied, and the user can be locked. The same dialog is opened when a user account is modified in the runtime. The final stage is to attribute the authorization levels this user can access, which are later used in the project to restrict access, only persons with this specific authorization level can execute the specific functionality. 5
6 3.2 User groups User groups are e established to group authorization levels to functionalities, e.g. Common functionalitites are attributed the authorization levels 1-20, Engineers have specific authorization levels of 50-60, Quality personnel utilize authorization levels Once user groups have been established d when creating or modifying user accounts under the tab User groups the individual groups are displayed, multiple groups can be selected, therefore an engineer can have Common functionalities and the Engineering group attributed. Additionally specific authorization levels can be attributed individually, therefore a user can be a Quality user and have additional ditional levels attributed. 3.3 Active Directory Under the User administration section in the Project settings User administration Active Directory can be enabled. Simply select Yes to enabled access to Active Directory and supply the connection parameters. 6
7 If the Active Directory Group name is also a User group name in zenon, this person is attribute the user group authorization levels. Individual authorization levels can be set in the Active Directory Group Description using HEX demonination. 3.4 Biometric logon Under the FDA regulations access to a system must be through two unique identifying properties from the user, a username and a password; this ensures as far as practically possible that the person logging in is the person authorized, and all reasonable attempts to stop unauthorized use of this login account have been made. The use of Biometric identification is allowed under the FDA regulation, but must ensure that the account cannot be used by anyone other than the intended user, and that the biometric system is capable of identifying a person uniquely. The biometric system connected to zenon will supply one variable with the identification of the user. This could be a user name, or number. Using the zenon function Login without password, this variable can be selected. When a value enters this variable, if the value is a user with an established account in the project, the user is logged in. 7
8 3.5 Project properties In the project properties User administration several settings must be inplace Delete user; should not be set, as user cannot be deleted in a regulated environment Password period of validity (days), should be set, a value above zero will enable password aging Password length, a zero value disables this check Maximum User errors, the system will be locked after unsuccessful user ID attempts Maximum Password errors, the user will be locked out after unsuccessfull password attempts Automatic log out (minutes), to only allow a certain access time after logging in 8
9 Additionally temporary login can be enabled here. When a user accesses a dynamic element which requires an authorization not currently active in the current login, a dialog box is opened where a temporary user can be logged in just for this operation. Once a user or system has been locked out, only a user with administrator privileges can perform a reset. 3.6 User administration at runtime User administration continues in the runtime. Two functions enable user administration at runtime, Change password allows a user to modify their password; Change User opens the administrator functionality, where a user can be locked, unlocked, passwords changed, authorization and user groups attributed, add new users, create or modify user groups. 4. Audit-trail The audit-trail must log all activity during runtime. By default the zenon audit-trail (Choronological Events List CEL ) records system events, such as user log in/out, start of system. In addition user actions and process variable events can be recorded in the audit-trail. Zenon also has integral Alarm management, in this section the activation of both the CEL & Alarms are each explained, however the two are separate entities and can be operated independently. 9
10 4.1 Process variables Process variables can be set certain characteristics depending on their purpose. Limit values are set at the variable to record critical process execptions or warnings. Manual changes of the variable must log From & To values, manual changes also require a reason for the change to be entered. Under Variable parameters Limits : Dynamic or static limits can be applied to a variable, to specify the states of the variable. The limit violation can be selected to be recorded in the audit-trail trail (CEL), and in the Alarm message list. Alarm management actions are selected here, with To acknowledge and Alarm group & classes. Alarms s can be classed and grouped, where the group could relate to equipment i.e. Reactor, Crystalizer, etc, to collate alarms to a specific process area. The class could relate to the severity of the alarm i.e. Information, Warning, Error, Critical process exception. These can be utilized & filtered later in the alarm management screen. Reaction matrices can be also be used to offer the same functionality as limit values, in addition all states of the variable can be attributed in one dialog: 10
11 The reaction matrix is first declared and configured. The reaction matrix is then linked to the variable in the Limits area of the variable. Common limits and texts can be defined in the reaction matrix and then attributed to several variables. When a variable is under the control control of the user such as a set point, manual changes to the variable must also be logged in the audit-trail, with the old and new values. Logging can be limited to dynamic elements when an operator makes the changes, or all write activity of this variable. 4.2 Dynamic elements To make changes to a variable (such as a set point change) a user must be logged in to the system with the required authorization to make the change. Each dynamic element must have an authorization level applied, and once a dynamic element has an authorization level a user needs this specific level to perform its function. The authorization level is attributed under the individual dynamic element properties Authorization, select the authorization level from the drop down box. Additionally a specific login on each change can be applied, this is achieved by selecting the Signature necessary. In this case even when a person is logged in to the system, the user will need to log in again to facilitate this change. A signature text can be applied automatically to the dynamic element, this text will appear in the audit-trail when a manual change is carried out. In most cases the signature text must be specific to each manual change, where the operator gives a specific reason for the manual change. This is a global project property, under the User administration properties of the project, activate the Signature text editable checkbox. 11
12 The configuration of the audit-trail trail so far would achieve the following results, when a manual change to a variable value is carried out: 1. The user is required to log in 2. A reason for the change is demanded from the operator as a signature text 3. The value is changed 4. The event is logged in the CEL 12
13 4.3 CEL logging The CEL data can be logged in two areas; firstly a local ringbuffer is held in memory, where a limited number of entries are recorded in a First-In-First-Out buffer; secondly data is stored on the hard disk. Under the Project properties Chronologic event list the behavior can be defined. The CEL of course needs to be active. Under Column settings CEL selection can be made on the information to be displayed, such as Variable name, User full name, Time, Unit, etc. Data storage CEL section; the ringbuffer is stored in memory and therefore the size is limted to a default of 100 events, this can be modified to suit a particular installation. As stated above the CEL can stored in memory as a ringbuffer and in the hard disk simultaneously. By changing the option Save CEL data this behavior is determined. Selecting Ringbuffer and historic data uses both area simultaneously; Only ringbuffer would not use the hard disk; Default depends on the operating system, under CE only the ringbuffer is used to save disk space, under other platforms both ringbuffer and hard disk are used. Enabling Save ringbuffer on change will save the CEL to hard disk on each event, disabling would only save the historic data to disk after 4k of data is generated, this saves hard disk usage. In a regulated environment due to the potential loss of data risk the options Save ringbuffer on change must be enabled, and the Ringbuffer and historic data should be selected. This would record each event to hard disk, and so in the event of a system crash, or power failure the data generated by the CEL would be saved. In the Logging section Alarm acknowledge must be checked. Finally the Recipe Group Manager (RGM) activity should be logged, select Log recipes and values for both Send recipes and Change recipes. This will record the changes made to recipes, and record which values were transfered to the equipment. 13
14 Within the calling function to the audit-trail CEL screen, the origin of the data can be selected to be either the Ringbuffer or the Historic data. If ringbuffer is selected only the last 100 events are displayed, with historic data the limit is user defined. Example zenon CEL Audit-trail. 4.4 Alarm logging The CEL lists all activity during operation including alarms, however the management of alarms is carried out in the alarm list. Here the alarms can be viewed, filtered, acknowledged, and comments added. The setup of the alarm list is similar to the CEL, and is located under Project properties Alarm message list. The Alarm Message list must be active, the ringbuffer and historic data must be saved, with the ringbuffer saved on each change. The behavior of the ringbuffer in the Alarm message list can be modified, First-In-First-Out, Last-In-First-Out, Reject new, can be selected. 14
15 The colours of the alarm status can be modified to suit a specific company standard, graphic elements can also be used to show alarm status. The Alarm management function also has a status line, which by default appears at the top of the screen. Operation of the status line can be activated/deactivated, and the alarm to display can be selected between oldest or newest alarm. Example Alarm message list 4.5 CEL & Alarm archiving The running data within the audit-trail CEL can be archived and so taken off-line. Three options exist to archive the data within the CEL, Exporting, Copy the actual CEL file, Print to.pdf. These three functions are available in zenon, and can be manual or event driven, such as a on a timed basis. 15
16 Export CEL function. Set the relative period of time to be exported. Print CEL function. Select the Chronological events list, the project defined printer is then used. To copy the CEL file, use the Windows file operations function. 16
17 5. Project wide activity 5.1 Function authorizations Under the Project properties User administration project wide settings can be applied, such as loading a project into the editor, acknowledge alarm restrictions. Open the properties by clicking on the Function authorizations, and select each property and the authorization level needed. 5.2 History of changes The history of changes within a project can be recorded, therefore keeping track of project activity carried out during development or modification. In the Project manager under History of changes all activity is recorded to trace project advancements, with Form and To values, the User, Computer name, Date & Time, etc. 17
18 The Histroy of changes is activated under Project properties History of changes, and the detail level is specified. Displaying changes to Object level will report which screen, function, variable, etc has changed. Property level would report on the property which has changed, position, color, etc. Values would record down to the actual value changes with Old & New values, e.g. Red to White, 5.3 Runtime changeable data When first creating the project, all project data needs to be transferred to the runtime; however once a system is operational certain data must only be changeable by the runtime. The User administration for example must only be changed using the runtime system. To control what is complied in a runtime the RT changeable data must be configured. Under the Project properties General, click on the RT changeable data and a dialog is opened, enable the checkbox User administration Do not generate and transfer. Now the runtime user administration accounts are not generated when the runtime is compiled, and so the runtime user administration remains untouched and is secured. 18
19 6. Check list Item Location Scope Comment User account Project properties Useradministration Once in project Are user accounts created Administrator account Project properties Useradministration Once in project At least one Administrator account needs to be created Delete users inactive Project properties Useradministration Once in project Deleting users is not allowed, user are locked to be made inactive Password aging Project properties Useradministration Once in project All passwords must expire Max user error Project properties Useradministration Once in project Unrecognized username signals unauthorized login, the system is locked after this number is reached Max password error Project properties Useradministration Once in project Incorrect password signals unauthorized login, the user is locked after this number is reached Timeout active Project properties Useradministration Once in project The logged in user must be automatically logged out Timeout value Project properties Useradministration Once in project Set the logout time RT User administrator Functions Change user Once in project Runtime function must be available to administer user accounts RT User password Functions Change password Once in project Runtime function must be available to change passwords Variable limit text Variable properties Limits Each variable Description of the limit violation In Alarm Message list active Variable properties Limits Each variable This alarm is listed and managed in the alarm message list To acknowledge active Variable properties Limits Each variable Alarms must be acknowledged To delete inactive Variable properties Limits Each variable Deleting an alarm is not allowed In Chronological Events list active Variable properties Limits Each variable Record limit violations in the audit-trail
20 Logging All or Only with dyn. Variable properties Limits Each variable Select the logging activity, operator and Element automated activity Old and new values active Variable properties Limits Each variable Record the 'From' and 'To' values when changing values Variable limit text Reaction matrix For each set of values Description of the limit violation In Alarm Message list active Reaction matrix For each set of values This alarm is listed and managed in the alarm message list To acknowledge active Reaction matrix For each set of values Alarms must be acknowledged To delete inactive Reaction matrix For each set of values Deleting an alarm is not allowed In Chronological Events list Reaction matrix For each set of values Record limit violations in the audit-trail active Link reaction matrix to variable Variable properties Limits Each variable The reaction matrix needs to be used with a variable Authorization level Dynamic element for each restricted activity, e.g. set point change Set the required level of authorization for this functionality Signature necessary active Dynamic element For each restricted activity, Force a user to login when a value change is e.g. set point change requested Signature text editable active Project properties Useradministration Once in project Allow the user to add a comment when a change is carried out CEL active Project properties Chronologic event list Once in project Activate the audit-trail operation Save ringbuffer on change Project properties Chronologic event list Once in project Save each audit-trail event to the hard disk active Save CEL data, Ringbuffer and historic data Project properties Chronologic event list Once in project Save audit-trail to both memory and hard disk Alarm acknowledge active Project properties Chronologic event list Once in project Record alarm acknowledgments in the audittrail Send recipes, Log recipes and Project properties Chronologic event list Once in project When a recipe is sent to the PLC the value values changes are written to Change recipes, Log recipes and values Project properties Chronologic event list Once in project the audit-trail When a recipe is changed the value changes are written to the audit-trail 20
21 Alarm Message list active Project properties Alarm Message list Once in project Activate the alarm management operation Save ringbuffer on change Project properties Alarm Message list Once in project Save each alarm event to the hard disk active Save AML data, Ringbuffer Project properties Alarm Message list Once in project Save alarm to both memory and hard disk and historic data History of changes active Project properties History of changes Once in project Record project activity Detailing level, value change Project properties History of changes Once in project Record with the all information RT changable data, User Project properties General RT changable Once in project In design the user accounts can be written to administration data the runtime, during operation this must not happen 21
22 COPA-DATA GmbH All rights reserved. Distribution and/or reproduction of this document or parts thereof in any form are permitted solely with the written permission of the COPA-DATA company. The technical data contained herein have been provided solely for informational purposes and are not legally binding. Subject to change, technical or otherwise.
Compliance Matrix for 21 CFR Part 11: Electronic Records
Compliance Matrix for 21 CFR Part 11: Electronic Records Philip E. Plantz, PhD, Applications Manager David Kremer, Senior Software Engineer Application Note SL-AN-27 Revision A Provided By: Microtrac,
More informationAgilent MicroLab Software with Spectroscopy Configuration Manager and Spectroscopy Database Administrator (SCM/SDA)
Agilent MicroLab Software with Spectroscopy Configuration Manager and Spectroscopy Database Administrator (SCM/SDA) Compliance with 21 CFR Part 11 Introduction Part 11 in Title 21 of the Code of Federal
More informationFull Compliance Contents
Full Compliance for and EU Annex 11 With the regulation support of Contents 1. Introduction 2 2. The regulations 2 3. FDA 3 Subpart B Electronic records 3 Subpart C Electronic Signatures 9 4. EU GMP Annex
More informationUser Bulletin. 8200 Cellular Detection System Analysis Software v4.0. Introduction. 21 CFR Part 11 Software Console - Administrators Guide
. User Bulletin 8200 Cellular Detection System Analysis Software v4.0 August 14, 2007 SUBJECT: 21 CFR Part 11 Software Console - Administrators Guide In This User Bulletin This user bulletin covers: Introduction.......................................................
More informationIntroduction. Activating the CFR Module License. CFR Configuration
Introduction Effective August 20, 1997, the United States Food and Drug Administration released its Code of Federal Regulations (CFR) Title 21 Part 11: Electronic Records; Electronic Signatures (21 CFR
More informationDeclaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007
Declaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007 SIEMENS AG Industry Sector Industry Automation D-76181 Karlsruhe, Federal Republic of Germany E-mail: pharma.aud@siemens.com Fax: +49
More informationCompliance Response Edition 07/2009. SIMATIC WinCC V7.0 Compliance Response Electronic Records / Electronic Signatures. simatic wincc DOKUMENTATION
Compliance Response Edition 07/2009 SIMATIC WinCC V7.0 Compliance Response Electronic Records / Electronic Signatures simatic wincc DOKUMENTATION Compliance Response Electronic Records / Electronic Signatures
More informationImplementing CitectSCADA to meet the requirements of FDA 21 CFR Part 11
Implementing CitectSCADA to meet the requirements of FDA 21 CFR Part 11 Version 2.0 July 2008 FDA 21 CFR Part 11 READY Reversed out on solid background colour Background In 1991, members of the pharmaceutical
More informationDeltaV Capabilities for Electronic Records Management
September 2004 Page 1 An integrated solution for meeting FDA 21CFR Part 11 requirements in process automation applications using a configurable off-the-shelf (COTS) solution Emerson Process Management.
More informationDeltaV Capabilities for Electronic Records Management
January 2013 Page 1 DeltaV Capabilities for Electronic Records Management This paper describes DeltaV s integrated solution for meeting FDA 21CFR Part 11 requirements in process automation applications
More informationepblue GxP oftware manual Software version 20.4.1 075 900.874
ee ab. pblue n. ig. p. manual GxP oftware manual epblue GxP Software manual Software version 20.4.1 075 900.874 Copyright 2012 Eppendorf AG, Hamburg. No part of this publication may be reproduced without
More informationThermal Analysis. http://www.fda.gov. Subpart A General Provisions 11.1 Scope. 11.2 Implementation. 11.3 Definitions.
Thermal Analysis 21 CFR 11 Compliance 21 CFR Part 11 Electronic Records; Electronic Signatures General concept The U.S. Federal Food and Drug Administration (FDA) has issued regulations that provide criteria
More informationFILEHOLD DOCUMENT MANAGEMENT SYSTEM 21 CFR PART 11 COMPLIANCE WHITE PAPER
FILEHOLD DOCUMENT MANAGEMENT SYSTEM 21 CFR PART 11 COMPLIANCE WHITE PAPER Copyright 2012 FileHold Systems Inc. All rights reserved. For further information about this manual or other FileHold Systems products,
More informationAccess Control and Audit Trail Software
Varian, Inc. 2700 Mitchell Drive Walnut Creek, CA 94598-1675/USA Access Control and Audit Trail Software Operation Manual Varian, Inc. 2002 03-914941-00:3 Table of Contents Introduction... 1 Access Control
More informationImplement best practices by using FileMaker Pro 7 as the backbone of your 21 CFR 11 compliant system.
21 CRF 11 Electronic Records and Signatures Implement best practices by using FileMaker Pro 7 as the backbone of your 21 CFR 11 compliant system. By Todd Duell What does Title 21 of the Code of Federal
More informationCopyright. Disclaimer. Introduction 1. System Requirements... 3. Installing the software 4
Digital Signatures User Guide Revision 1.2 build 1, Document Revision 1.12 Published 31. Octover 2011 ii Contents Copyright Disclaimer iii iii Introduction 1 System Requirements... 3 Installing the software
More information21 CFR PART 11 ELECTRONIC RECORDS, ELECTRONIC SIGNATURES 21.11.2013. 21 CFR Part 11 Compliance PLA 2.1
21 CFR PART 11 ELECTRONIC RECORDS, ELECTRONIC SIGNATURES Compliance of PLA 2.1 21.11.2013 21 CFR Part 11 Compliance PLA 2.1 SEC. 11.2 IMPLEMENTATION. (a) For records required to be maintained but not submitted
More informationThe Impact of 21 CFR Part 11 on Product Development
The Impact of 21 CFR Part 11 on Product Development Product development has become an increasingly critical factor in highly-regulated life sciences industries. Biotechnology, medical device, and pharmaceutical
More information2010 Ing. Punzenberger COPA-DATA GmbH. All rights reserved.
2010 Ing. Punzenberger COPA-DATA GmbH All rights reserved. Distribution and/or reproduction of this document or parts thereof in any form are permitted solely with the written permission of the company
More informationAnalyst 1.6 Software. Laboratory Director s Guide
Analyst 1.6 Software Laboratory Director s Guide Release Date: August 2011 This document is provided to customers who have purchased AB SCIEX equipment to use in the operation of such AB SCIEX equipment.
More informationGPS Tracking Software Training and User Manual
GPS Tracking Software Training and User Manual Table of Contents Introduction... 4 Login Page... 4 Dashboard... 4 Create Group... 5 Edit Group... 6 Group Editor... 6 Add New Vehicle... 7 Configure Tracking...
More informationUSER MANUAL (PRO-CURO LITE, PRO & ENT) [SUPPLIED FOR VERSION 3]
Pro-curo Software Ltd USER MANUAL (PRO-CURO LITE, PRO & ENT) [SUPPLIED FOR VERSION 3] CONTENTS Everyday use... 3 Logging on... 4 Main Screen... 5 Adding locations... 6 Working with locations... 7 Duplicate...
More informationJPMorgan Chase Treasury Workstation. Certification Setup Guide Version 2.0
EMENTS JPMorgan Chase Treasury Workstation Certification Setup Guide Version 2.0 December 2010 TABLE OF CONTENTS Introduction... 1 About this Guide... 1 When to Create the Certificates... 2 Getting Help...
More informationNetWrix Logon Reporter V 2.0
NetWrix Logon Reporter V 2.0 Quick Start Guide Table of Contents 1. Introduction... 3 1.1. Product Features... 3 1.2. Licensing... 4 1.3. How It Works... 5 1.4. Report Types Available in the Advanced Mode...
More informationFuseMail- Exchange ControlPanel Admin Guide Feb.27-14 V1.0. Exchange ControlPanel Administration Guide
Exchange ControlPanel Administration Guide Table of Contents Top Level Portal Administration... 4 Signing In to Control Panel... 4 Restoring Account Password... 5 Change Account Details... 7 Viewing Account
More informationFDA 21 CFR Part 11 Features
FDA 21 CFR Part 11 Features Introduction... 2 Remarks... 3 General... 3 Electronic Records (Event Logger, Alarms, Reports)... 3 Electronic Signatures (Security System)... 3 Security System... 4 Security
More informationElectronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device industries
White Paper No 01 I December 2010 Implementation of 21 CFR Part 11 in the epmotion Software Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device
More informationHow To Use Syntheticys User Management On A Pc Or Mac Or Macbook Powerbook (For Mac) On A Computer Or Mac (For Pc Or Pc) On Your Computer Or Ipa (For Ipa) On An Pc Or Ipad
SYNTHESYS MANAGEMENT User Management Synthesys.Net User Management 1 SYNTHESYS.NET USER MANAGEMENT INTRODUCTION...3 STARTING SYNTHESYS USER MANAGEMENT...4 Viewing User Details... 5 Locating individual
More informationProficyTM. HMI/SCADA - ifix I MPLEMENTING S ECURITY
ProficyTM HMI/SCADA - ifix I MPLEMENTING S ECURITY Version 4.0 December 2005 All rights reserved. No part of this publication may be reproduced in any form or by any electronic or mechanical means, including
More informationUsing Electronic Signatures
Using Electronic Signatures Copyright Proprietary Notice The manual and software contain confidential information which represents trade secrets of GE Fanuc International, Inc. and/or its suppliers, and
More informationAchieving PCI COMPLIANCE with the 2020 Audit & Control Suite. www.lepide.com/2020-suite/
Achieving PCI COMPLIANCE with the 2020 Audit & Control Suite 7. Restrict access to cardholder data by business need to know PCI Article (PCI DSS 3) Report Mapping How we help 7.1 Limit access to system
More informationSecurity, Audit, and e-signature Administrator Console v1.2.x
Security, Audit, and e-signature Administrator Console v1.2.x USER GUIDE SAE Admin Console for use with: QuantStudio Design and Analysis desktop Software Publication Number MAN0010410 Revision A.0 For
More informationefiletexas.gov Court Administrator User Guide
efiletexas.gov Court Administrator User Guide EFS-TX-200-3191 v.4 February 2014 Copyright and Confidentiality Copyright 2014 Tyler Technologies, Inc. All rights reserved. All documentation, source programs,
More information21 CFR Part 11 Implementation Spectrum ES
21 CFR Part 11 Implementation Spectrum ES INFRARED SPECTROSCOPY T E C H N I C A L N O T E Introduction Compliance with 21 CFR Part 11 is mandatory for pharmaceutical companies and their suppliers to sell
More informationSolidWorks Enterprise PDM and FDA 21CFR Part 11
T E C H N I C A L P A P E R SolidWorks Enterprise PDM and FDA 21CFR Part 11 This Technical Paper discusses the technical solutions provided by SolidWorks Enterprise PDM to address the FDA 21 CFR Part 11
More information21 CFR Part 11 White Paper
21 CFR Part 11 White Paper Version V8.00 SR1 ProLeiT AG Einsteinstrasse 8, D-91074 Herzogenaurach, Germany Phone: +49 (0) 9132 777-0 Fax: +49 (0) 9132 777-150 E-Mail: info@proleit.com Internet: http://www.proleit.com
More informationPaymentNet Federal Card Solutions Cardholder FAQs
PaymentNet Federal Card Solutions It s easy to find the answers to your questions about PaymentNet! June 2014 Frequently Asked Questions First Time Login How do I obtain my login information?... 2 How
More informationCharter Business Desktop Security Administrator's Guide
Charter Business Desktop Security Administrator's Guide Table of Contents Chapter 1: Introduction... 4 Chapter 2: Getting Started... 5 Creating a new user... 6 Recovering and changing your password...
More informationKaseya 2. User Guide. Version 1.1
Kaseya 2 Directory Services User Guide Version 1.1 September 10, 2011 About Kaseya Kaseya is a global provider of IT automation software for IT Solution Providers and Public and Private Sector IT organizations.
More informationSpectroscopy Configuration Manager (SCM) Software. 21 CFR Part 11 Compliance Booklet
Spectroscopy Configuration Manager (SCM) Software 21 CFR Part 11 Compliance Booklet Notices Agilent Technologies, Inc. 2015 No part of this manual may be reproduced in any form or by any means (including
More informationAgilent ChemStation Security Pack for AD, GC, LC, CE, LC-MSD, and CE-MSD. User s Guide
Agilent ChemStation Security Pack for AD, GC, LC, CE, LC-MSD, and CE-MSD User s Guide A Notices Agilent Technologies, Inc. 2004 No part of this manual may be reproduced in any form or by any means (including
More informationSelf-Assessment of eresearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures
Self-Assessment of eresearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures Subpart A General Provisions Sec. 11.1 Scope. (a) The regulations in this part set forth the criteria
More informationUser Guide QAD Security and Controls
QAD Enterprise Applications Enterprise Edition User Guide QAD Security and Controls Introduction to Security and Controls Security Overview Setting Up Security Control Setting Up Users and Roles Segregation
More information21 CFR Part 11 Compliance Using STATISTICA
21 CFR Part 11 Compliance Using STATISTICA Last Updated: April 2003 This document was updated to reflect the FDA s latest guidance (released February, 2003) and the withdrawal of previous guidance.! STATSOFT
More informationAT&T Business Messaging Account Management
AT&T Business Messaging Account Management Admin User Guide December 2015 1 Copyright 2015 AT&T Intellectual Property. All rights reserved. AT&T, the AT&T logo and all other AT&T marks contained herein
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 informationCompliance in the BioPharma Industry. White Paper v1.0
in the BioPharma Industry White Paper v1.0 July 2005 I. Introduction...3 II. Overview of Regulations...3 III. Overview of Validation...4 a. Validation...4 b. Security s Part Within Validation...6 IV. Introduction
More informationObjectives. At the end of this chapter students should be able to:
NTFS PERMISSIONS AND SECURITY SETTING.1 Introduction to NTFS Permissions.1.1 File Permissions and Folder Permission.2 Assigning NTFS Permissions and Special Permission.2.1 Planning NTFS Permissions.2.2
More informationEPM Performance Suite Profitability Administration & Security Guide
BusinessObjects XI R2 11.20 EPM Performance Suite Profitability Administration & Security Guide BusinessObjects XI R2 11.20 Windows Patents Trademarks Copyright Third-party Contributors Business Objects
More informationtesto Saveris 21CFR Part 11 Software Instruction manual
testo Saveris 21CFR Part 11 Software Instruction manual 2 1 Contents 1 Contents 1 Contents... 3 2 Specifications... 4 2.1. Intended purpose... 4 2.2. 21 CFR Part 11 and terminology used... 5 3 First steps...
More informationU.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Records Management
U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Records Management Disclaimer These materials are subject to change without notice. SAP AG s compliance analysis with respect to SAP software
More informationManaging FactoryTalk Security for Multiple FactoryTalk View Studio Applications
Managing FactoryTalk Security for Multiple FactoryTalk View Studio Applications Relevant Products - FactoryTalk View Machine Edition 5.0 - RSView Machine Edition 4.0 - FactoryTalk View Supervisory Edition
More informationSHIMADZU CORPORATION
638-94259 Total Organ Carbon Analyzer TOC-V Administrator's Manual Read this manual carefully and keep it with the instrument for future reference. SHIMADZU CORPORATION ANALYTICAL & MEASURING INSTRUMENTS
More informationAuthentiMax Software for GloMax -Multi+
TECHNICAL MANUAL AuthentiMax Software for GloMax -Multi+ Instruc ons for use of Product E8946. TM403 Revised 9/13 AuthentiMax Software for GloMax -Multi+ All technical literature is available on the Internet
More informationCompliance Response SIMATIC SIMATIC PCS 7 V8.1. Electronic Records / Electronic Signatures (ERES) Edition 03/2015. Answers for industry.
SIMATIC SIMATIC PCS 7 V8.1 Electronic Records / Electronic Signatures (ERES) Compliance Response Edition 03/2015 Answers for industry. Compliance Response Electronic Records / Electronic Signatures (ERES)
More informationCLOUDPM CITY LEDGER USER GUIDE
Multi-Systems Inc. December 13, 2012 Page 1 of 11 Table of Contents City Ledger... 3 City Ledger Database... 3 Creating City Ledger Department Codes... 3 Adding City Ledger Department Codes to Accounting
More informationTurboTag User Manager Software Version 1.3.0.0 Setup and Operating Instructions. Table of Contents
www.turbotag.com TurboTag User Manager Software Version 1.3.0.0 Setup and Operating Instructions Table of Contents Electronic Signatures and Administration of Session Manager DB Software... 2 Installation
More informationTools to Aid in 21 CFR Part 11 Compliance with EZChrom Elite Chromatography Data System. White Paper. By Frank Tontala
Tools to Aid in 21 CFR Part 11 Compliance with EZChrom Elite Chromatography Data System White Paper By Frank Tontala Agilent Technologies Software & Informatics Life Sciences & Chemical Analysis Group
More information2010 Ing. Punzenberger COPA-DATA GmbH. All rights reserved.
2010 Ing. Punzenberger COPA-DATA GmbH All rights reserved. Distribution and/or reproduction of this document or parts thereof in any form are permitted solely with the written permission of the company
More informationDANGER indicates that death or severe personal injury will result if proper precautions are not taken.
Multi-User Systems 1 ArchiveServer 2 SIMATIC HMI WinCC V7.0 SP1 File Server 3 WinCC ServiceMode 4 Redundant Systems 5 System Manual Print of the Online Help 11/2008 Legal information Warning notice system
More informationCollaborate.ets.org Password Setup & Recovery Guide. Table of Contents
MyPassword is a self-service password management tool. Collaborate.ets.org Password Setup & Recovery Guide https://mypassword.ets.org/ Table of Contents Create/Edit Your Profile (First time use)... I Change
More informationInfinityQS SPC Quality System & FDA s 21 CFR Part 11 Requirements
InfinityQS SPC Quality System & FDA s 21 CFR Part 11 Requirements www.infinityqs.com Copyright InfinityQS International Table of Contents Overview... FDA s 21 CFR Part 11 Requirements... PART 11 ELECTRONIC
More informationAESDIRECT ACCOUNT ADMINISTRATION USER GUIDE
AESDIRECT ACCOUNT ADMINISTRATION USER GUIDE Updated June 24, 2014 Table of Contents OVERVIEW... 3 AESDirect Roles Defined... 3 Account Administrator... 3 User Managers... 3 Users... 4 AESDIRECT RULES...
More informationCouncil of Ontario Universities. COFO Online Reporting System. User Manual
Council of Ontario Universities COFO Online Reporting System User Manual Updated September 2014 Page 1 Updated September 2014 Page 2 Table of Contents 1. Security... 5 Security Roles Defined in the Application...
More informationNETWRIX ACCOUNT LOCKOUT EXAMINER
NETWRIX ACCOUNT LOCKOUT EXAMINER ADMINISTRATOR S GUIDE Product Version: 4.1 July 2014. Legal Notice The information in this publication is furnished for information use only, and does not constitute a
More informationIn this topic we will cover the security functionality provided with SAP Business One.
In this topic we will cover the security functionality provided with SAP Business One. 1 After completing this topic, you will be able to: Describe the security functions provided by the System Landscape
More informationFDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry
FDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry The Rule 21 CFR Part 11 Handwritten signature means the scripted name or legal mark of an individual handwritten
More informationMANAGED FILE TRANSFER: 10 STEPS TO SOX COMPLIANCE
WHITE PAPER MANAGED FILE TRANSFER: 10 STEPS TO SOX COMPLIANCE 1. OVERVIEW Do you want to design a file transfer process that is secure? Or one that is compliant? Of course, the answer is both. But it s
More informationLast updated: October 4, 2013. einvoice. Attorney Manual
einvoice Attorney Manual Welcome to the Bexar County einvoice system! The Bexar County einvoice System is designed to help attorneys submit and track invoices with Bexar County. With this system, an attorney
More informationReview and Approve Results in Empower Data, Meta Data and Audit Trails
Review and Approve Results in Empower Data, Meta Data and Audit Trails 2013 Waters Corporation 1 What is an audit trail? Systematic story of the data from creation, through interpretation and final assessment
More informationUsing the Content Distribution Manager GUI
CHAPTER 3 Using the Content Distribution Manager GUI The Content Distribution Manager is the central location from which much of the work of creating and managing ACNS networks and hosted content can be
More informationEmpower TM 2 Software
Empower TM 2 Software 21 CFR PART 11 COMPLIANCE ASSESSMENT Revision A, December, 2005 1 of 14 Waters Corporation Note: Information presented in this document assumes that the appropriate Empower 2 System
More informationPREPARED BY: AUDIT PROGRAM Author: Lance M. Turcato. APPROVED BY: Logical Security Operating Systems - Generic. Audit Date:
A SYSTEMS UNDERSTANDING A 1.0 Organization Objective: To ensure that the audit team has a clear understanding of the delineation of responsibilities for system administration and maintenance. A 1.1 Determine
More information2010 Ing. Punzenberger COPA-DATA GmbH. All rights reserved.
2010 Ing. Punzenberger COPA-DATA GmbH All rights reserved. Distribution and/or reproduction of this document or parts thereof in any form are permitted solely with the written permission of the company
More informationAT&T Online Fax User Guide Version 1.0
AT&T Online Fax User Guide Version 1.0 Welcome to AT&T Website Solutions SM We are focused on providing you the very best web hosting service including all the tools necessary to establish and maintain
More informationUser s Guide for the Texas Assessment Management System
User s Guide for the Texas Assessment Management System Version 8.3 Have a question? Contact Pearson s Austin Operations Center. Call 800-627-0225 for technical support Monday Friday, 7:30 am 5:30 pm (CT),
More informationIntroduction. Editions
Introduction TRAIN TRACK Employee Training Management Software gives you the tools you need to make sure employee training requirements are met. Assign required training for groups or individuals. Easily
More informationResource Online User Guide JUNE 2013
Resource Online User Guide JUNE 2013 CHASE PAYMENTECH SOLUTIONS MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, WITH REGARD TO THIS MATERIAL, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES
More informationSage Abra SQL HRMS System. User Guide
Sage Abra SQL HRMS System User Guide 2009 Sage Software, Inc. All rights reserved. Sage, the Sage logos, and the Sage product and service names mentioned herein are registered trademarks or trademarks
More informationGetting Started. Business Link. User Name Rules. Hardware/Software Requirements. Password Rules
Getting Started User Name Rules All user names must: Be unique. Be between six and 40 characters in length. Notes: It is recommended that user names consist only of alphanumeric characters (A-Z, 0-9).
More informationSalesforce Classic Guide for iphone
Salesforce Classic Guide for iphone Version 37.0, Summer 16 @salesforcedocs Last updated: July 12, 2016 Copyright 2000 2016 salesforce.com, inc. All rights reserved. Salesforce is a registered trademark
More informationDeltek Touch Time & Expense for GovCon. User Guide for Triumph
Deltek Touch Time & Expense for GovCon User Guide for Triumph November 25, 2014 While Deltek has attempted to verify that the information in this document is accurate and complete, some typographical or
More informationAutoSave. Achieving Part 11 Compliance. A White Paper
AutoSave Achieving Part 11 Compliance A White Paper Synopsis This whitepaper provides information related to FDA regulation 21 CFR Part 11 (Part 11) for organizations considering MDT software solutions.
More informationLabChip GX/GXII with LabChip GxP Software
Regulatory Compliance LabChip GX/GXII with LabChip GxP Software Supporting Regulatory Compliance Caliper LabChip GX/GXII suite of instruments provides automated electrophoresis to analyze quality, size,
More informationHow to install and use the File Sharing Outlook Plugin
How to install and use the File Sharing Outlook Plugin Thank you for purchasing Green House Data File Sharing. This guide will show you how to install and configure the Outlook Plugin on your desktop.
More informationNotice to Government End Users DoD contract: Civilian agency contract:
SHIFT4, $$$ ON THE NET, $$$ IN THE BANK, FRAUD SENTRY, and IT'S YOUR CARD are products and Registered Trademarks of Shift4 Corporation. NetAPI, NetAudit, and NetCharge are products and Trademarks of Shift4
More informationMeeting the FDA s Requirements for Electronic Records and Electronic Signatures (21 CFR Part 11)
Meeting the FDA s Requirements for Electronic Records and Electronic Signatures (21 CFR Part 11) Executive Summary...3 Background...4 Internet Growth in the Pharmaceutical Industries...4 The Need for Security...4
More informationVendor Portal User Guide
State of Illinois Illinois Department of Transportation Vendor Portal User Guide Version 2.1 November 2015 0137-16, 11/15, web Item Document Title File Name Disposition Author Document Description Description
More informationDigital Commons Journal Guide: How to Manage, Peer Review, and Publish Submissions to Your Journal
bepress Digital Commons Digital Commons Reference Material and User Guides 6-2016 Digital Commons Journal Guide: How to Manage, Peer Review, and Publish Submissions to Your Journal bepress Follow this
More informationPortal User Guide. Customers. Version 1.1. May 2013 http://www.sharedband.com 1 of 5
Portal User Guide Customers Version 1.1 May 2013 http://www.sharedband.com 1 of 5 Table of Contents Introduction... 3 Using the Sharedband Portal... 4 Login... 4 Request password reset... 4 View accounts...
More informationMANAGED FILE TRANSFER: 10 STEPS TO HIPAA/HITECH COMPLIANCE
WHITE PAPER MANAGED FILE TRANSFER: 10 STEPS TO HIPAA/HITECH COMPLIANCE 1. OVERVIEW Do you want to design a file transfer process that is secure? Or one that is compliant? Of course, the answer is both.
More informationEgnyte App for Android Quick Start Guide
Egnyte App for Android Quick Start Guide Introduction Welcome to the Quick Start Guide for the Egnyte App for Android. This guide will explain how to: Access files. Download content for offline access.
More informationUser Guide for the 21 CFR Part 11 Module in SDS Software v1.4
Applied Biosystems 7500/7500 Fast Real-Time PCR System User Guide for the 21 CFR Part 11 Module in SDS Software v1.4 Introduction Installation Logging in to the SDS Software Configuring the 21CFR11 Module
More informationAdministration Guide. . All right reserved. For more information about Specops Password Sync and other Specops products, visit www.specopssoft.
Administration Guide. All right reserved. For more information about Specops Password Sync and other Specops products, visit www.specopssoft.com Copyright and Trademarks Specops Password Sync is a trademark
More informationVirtual Code Authentication User Guide for Administrators
Virtual Code Authentication User Guide for Administrators Virtual Code Authentication - User Guide for Administrators Document No.: 05-001 2001-2015 All rights reserved. Under copyright laws, this document
More informationGEAR UP Virginia Database Program User Guide
GEAR UP Virginia Database Program User Guide Contents Click on topic to advance to specific section. GEAR UP Virginia Program Database Introduction and security information 3 User/Login Names and Password
More informationConnection to USOE Terminal Server 3/30/2006
Connection to USOE Terminal Server 3/30/2006 Installing the Client In order to install the Remote Desktop and the Remote Printing you will need to have administrator rights to your machine. If you don
More informationefiletexas.gov Review Queue User Guide
efiletexas.gov Review Queue User Guide EFS-TF-200-3194 v.4 February 2014 Copyright and Confidentiality Copyright 2014 Tyler Technologies, Inc. All rights reserved. All documentation, source programs, object
More informationJob Aid - Avaya Aura Messaging. Purpose. Restarting software and server. Stopping. Procedure
Job Aid - Avaya Aura Messaging Release 6.3.2 Issue 1 December 2014 Purpose This document includes the processes that administrators frequently use for administration of the Messaging system. The content
More informationInfoCenter Suite and the FDA s 21 CFR part 11 Electronic Records; Electronic Signatures
InfoCenter Suite and the FDA s 21 CFR part 11 Electronic Records; Electronic Signatures Overview One of the most popular applications of InfoCenter Suite is to help FDA regulated companies comply with
More information