21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide

Transcription

1 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 2017 Dassault Systèmes. Apriso, 3DEXPERIENCE, the Compass logo and the 3DS logo, CATIA, SOLIDWORKS, ENOVIA, DELMIA, SIMULIA, GEOVIA, EXALEAD, 3D VIA, BIOVIA, NETVIBES, and 3DXCITE are commercial trademarks or registered trademarks of Dassault Systèmes or its subsidiaries in the U.S. and/or other countries. All other trademarks are owned by their respective owners. Use of any Dassault Systèmes or its subsidiaries trademarks is subject to their express written approval.

2 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 2 Contents 1 Introduction Abstract Overview 4 2 Function Interpreter (DELMIA Apriso Runtime) Solution Overview Implementation/Configuration Electronic Signatures Using Standard Operation (BPF) Electronic Signatures Using Business Component Audit Configuration Usage/Administration Standard Operation (BPF) Business Component Audit Trail Data Model 8 3 Process Authoring and Deployment Process Builder Solution Overview Implementation/Configuration Usage/Administration Global Process Manager Solution Overview Implementation/Configuration Usage/Administration 11 4 Maintenance and Monitoring Screens (Framework) Solution Overview List of Supported Screens Implementation/Configuration Usage/Administration Performing Changes to the Data (Single Signature) Viewing Changes to the System Data (Changelog) Viewing Locked Entities/Unlocking Locked Entities Approving/Rejecting Changes (Double Signature) 18 5 General Security Policy Solution Overview Implementation/Configuration Usage/Administration Data Model 21 6 References 22

3 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 3 Figures Figure 1 Electronic Signature in Function Interpreter 5 Figure 2 The Electronic Signature Operation within a Processes 6 Figure 3 Process authoring and deployment flow 9 Figure 4 Electronic Signature in Process Builder 10 Figure 5 Electronic Signature in Global Process Manager 11 Figure 6 Changelogs screen 12 Figure 7 Checking in the changes to an 21-CFR-Part-11-regulated screen 16 Figure 8 Sample Changelog Report 17 Figure 9 Signature Locked Entity screen 18 Figure 10 Approval Cockpit screen 19 Figure 11 Security Log screen 21

4 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 4 1 Introduction 1.1 Abstract This document describes how the FDA s 21 Code of Federal Regulations (21 CFR Part 11) on Electronic Records/Electronic Signatures are incorporated in the DELMIA Apriso solution. It describes what modules are enhanced with the Electronic Signature-related functionality and how DELMIA Apriso (as a set of those modules) should be configured to support it. The document is intended for individuals preparing DELMIA Apriso implementations to support the Electronic Records/Electronic Signature framework. 1.2 Overview As 21 CFR Part 11 enforces data security on production environments, the Apriso areas that are responsible for that data allow the tracking and approval of all modifications. The following areas of the DELMIA Apriso suite are enhanced with the relevant functionality: Function Interpreter (DELMIA Apriso runtime) Process Builder and Global Process Manager Monitoring and Maintenance Monitoring Screens (framework) General security policy Each of these components must be configured and used in the specific ways described in the relevant sections of this document. Usage and the user interface framework related to Electronic Records/Electronic Signatures in the above modules is described in the respective user documentation. References are available in 6 References.

5 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 5 2 Function Interpreter (DELMIA Apriso Runtime) 2.1 Solution Overview The 21 CFR Part 11 regulation enforces a requirement to support Electronic Signatures within DELMIA Apriso during the execution of Processes or Standard Operations. This means that during runtime, the system must be able to prompt the user to sign off on their work (Single Signature), and, in some cases, to have a supervisor approve this work (Double Signature). All the operations approved with Electronic Signatures must be associated with the signatures for reporting purposes and history. To comply with these requirements, Dassault Systèmes provides a method of configuring Processes and Standard Operations to support the necessary signatures if required (through a 21-CFR-Part-11-regulated environment). It is assumed that it is the Process Author s decision if the 21-CFR-Part-11-regulated environment is to be implemented and, if so, if Single or Double Signatures are necessary for the specific implementation. During the design time, the Process Author is provided with: A Standard Operation (BPF) This is part of the Electronic Signatures Business Process Flow (BPF) and is meant for use with Business Component methods (as described below) in the most standardized manner in environments that do not require customization. The Operation is: APR_ElectronicSignature. Its incorporation within a Process is described in Electronic Signatures Using Standard Operation (BPF). A Business Component This Business Component contains five methods for composing custom Processes and/or Operations that require the Electronic Signature functionality with greater flexibility (as described in Electronic Signatures Using Business Component). The Audit Trail Monitoring and Maintenance screen (when configured appropriately as described in Audit Configuration) displays signature information along with the changes made to the audited data. The flow for configuring a process, executing it, and changing the verification in the Function Interpreter of a 21-CFR-Part-11-regulated environment is presented in Figure 1. Process Author embeds Electronic Signature within his process (using PB) Employee executing the process provides Electronic Signature when prompted and (optionally) has his supervisor approve his work (in FI) Author verifies changes against the Electronic Signature (using Audit M&M Screen) Figure 1 Electronic Signature in Function Interpreter

6 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide Implementation/Configuration Electronic Signatures Using Standard Operation (BPF) Figure 2 presents two sample Processes that use the Electronic Signatures BPF in different places. The figure indicates which parts of the Process will be affected. The Process Author must design the Process/Standard Operation in such a way that the signature Sub Operation (APR_ElectronicSignature) is the first thing executed within a Step if all the succeeding activities are to be associated with that signature. Start FI Step 1 Start FI Step 1 Invoke BC 1 These BCs will not be linked to the signature Invoke BC 1 These BCs will not be linked to the signature Render information to user This is where the process author can render the information that is to be approved Render information to user This is where the process author can render the information that is to be approved Stop FI Step 1 Stop FI Step 1 Start FI Step 2 Start FI Step 2 Invoke Signature BPF This BPF will invoke the create signature BC Invoke BC 2 These BCs will not be linked to the signature Invoke BC 2 Invoke BC 3 } These BCs will be linked to the signature Invoke Signature BPF Invoke BC 3 This BPF will invoke the create signature BC These BCs will be linked to the signature Stop FI Step 1 Stop FI Step 1 Single Signature Required Figure 2 The Electronic Signature Operation within a Processes If the Process Author determines that an Electronic Signature is required within their Process or Standard Operation, he or she must perform the following steps: 1 Add the Electronic Signature functionality by linking in the Electronic Signature Operation. The system will show all the available Inputs to be used for runtime and configuration.

7 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 7 2 Determine whether only a Single Signature is required, and configure the Inputs appropriately. 3 Determine if someone other than the employee who is logged in is allowed to perform the first signature, and configure the Inputs appropriately. 4 Determine if a comment is required to perform the first signature, and configure the Inputs appropriately. 5 Determine if a reason is required to perform the first signature, and configure the Inputs appropriately. Double Signature Required During step 2 of the previous flow, the Process Author may determine that a Double Signature is required. The Process Author must first complete steps 3 through 5 above and then: 1 Determine if the Supervisor who needs to perform the Double Signature is a specific employee or whether just a specific role is required, and configure the Inputs appropriately. 2 Determine if a comment is required to perform the Double Signature, and configure the Inputs appropriately. 3 Determine if a reason is required to perform the Double Signature, and configure the Inputs appropriately Electronic Signatures Using Business Component The Signature Business Component (FlexNet.BusinessFacade.Signature.SignatureManager) is responsible for creating database records for Electronic Signatures in a 21-CFR-Part-11- regulated environment. The Signature BC does not generate any BC history records and does not depend on any other BC. The following Business Component methods are available: SaveSingleSignature SaveDoubleSignature IsInSignedContext SignatureByID ResetSignature The methods should be used in Processes and Operations by experienced personnel when advanced customization of the signing process is required. For more information on the Signature Business Component, refer to the Business Components Documentation Audit Configuration In addition to configuring Processes, the Process Author is required to set up the Audit in such a way that it monitors changes to the tables and/or fields affected by those Processes. The configuration is done via the Audit Configuration screen. Configuration of the Audit is described in detail in the Audit Trail Technical Guide. Use of the Audit in the Electronic Signature context is described below in Audit Trail.

8 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide Usage/Administration Standard Operation (BPF) The user must provide his or her credentials and a comment (if required) whenever requested to during the Process flow being executed Business Component The user must provide his or her credentials and a comment (if required) whenever requested during the Process flow being executed Audit Trail When the changes associated with an Electronic Signature are audited (included in the Audit Trail), they can be viewed by authorized personnel (e.g., the System Administrator) on the Audit Trail Monitoring and Maintenance screen, which can be navigated to in the DELMIA Apriso Desktop Client. Choose a record, click (Audit Trail) and then click (Signature) to display the Electronic Signature associated with a specific record in the form of a pop-up window (as shown in Figure 1). 2.4 Data Model To support Electronic Signatures, the TRANSACTION_HISTORY_SIGNATURE table is used. Details and description of the table and its columns are available in the Database Documentation.

9 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 9 3 Process Authoring and Deployment Processes in DELMIA Apriso are designed using Process Builder. When completed and tested, they are deployed on an environment using Global Process Manager, where they are normally used. In this approach, 21 CFR Part 11 regulation is implemented on both of these modules, making it necessary to have all the Processes approved a first time (that is, during their release with a change of status from Prototype to Active) and a second time (during their deployment). Dassault Systèmes recommends that a 21-CFR-Part-11-regulated environment is comprised of at least two separate DELMIA Apriso instances (servers) One for designing, creating, and testing the Processes One for running the production The design environment should be configured in such a way that Process Builder requires Process Authors to sign off on their work when ready-to-go Processes are released (as described in Solution Overview). This signature is the first signature according to the 21 CFR Part 11 regulation. Process Builder should be configured as described in Implementation/Configuration. The production environment should have Global Process Manager configured in order to require that Deployment Managers sign off on their work when deploying data to the server (as described in Solution Overview). This is the second approval signature. Global Process Manager should be configured as described in 4.3 Implementation/Configuration. PB: - DisableDesignMode GPM: - RequireSignOffOnDeployment - AllowDeploymentOfPrototype Production Environment A Design Environment Process Designers PB Supervisor (first signature) GPM PB: - RequireSignOffOnRelease - ShowNoteOnSave GPM: [no recommendations] Deployment Manager (second signature) Production Environment B Figure 3 Process authoring and deployment flow

10 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide Process Builder Solution Overview Because Process Builder serves as the Process authoring tool for DELMIA Apriso, it is essential that it requires users creating new Processes/Operations or performing changes to existing Processes/Operations to sign their work using an Electronic Signature when working in a CFR-Part-11-regulated environment (that is, on design or production servers). The system requires the sign off when a Process or Operation is released (that is, its status is changed to Active). Accordingly, it is possible for any user to make changes to an entity (that is, a Process or an Operation), but applying the changes is the responsibility of a single individual who is obliged to review the changes before their eventual approval or rejection (which is based on the notes provided by those who performed the changes). Figure 4 Electronic Signature in Process Builder Implementation/Configuration Implementation of a 21-CFR-Part-11-regulated environment for Process Authoring entails configuring whether the 21-CFR-Part-11-regulated environment should be in force when releasing a Process or Operation as well as to two additional settings. The configuration is done through RequireSignOffOnRelease, ShowNoteOnSave and DisableDesignMode keys located in the ProcessBuilder section of the Central Configuration file (for details, see Central Configuration Documentation) Usage/Administration For details on releasing entities in a CFR-Part-11-regulated environment and all the UI elements connected to this process, see the Process Builder Online Help. 3.2 Global Process Manager Solution Overview Because Global Process Manager can deploy ready-to-go Processes and packaged sets of changes to DELMIA Apriso production servers, it is essential that it requires users to sign

11 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 11 their work using an Electronic Signature when deploying data while working in a CFR-Part- 11-regulated environment. The system requires a sign off when a package (with any type of content) is deployed on a server that has that requirement. Packages (Package Actions) deployed in a CFR-Part-11- regulated environment have the additional Signature tab in their properties, which allows for the viewing of signature details. Deployment Managers use this information to finally approve the change performed. Figure 5 Electronic Signature in Global Process Manager Implementation/Configuration Implementation of a 21-CFR-Part-11-regulated environment for Global Process Manager entails configuring whether it should be in force when deploying a package. Configuration is done through RequireSignOffOnDeployment and AllowDeploymentOfPrototype keys located in the DeploymentServices section of the Central Configuration file (for details, see Central Configuration Documentation) Usage/Administration For details on deploying packages in a CFR-Part-11-regulated environment as well as all the UI elements connected to this process, please see the Global Process Manager Online Help.

12 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 12 4 Maintenance and Monitoring Screens (Framework) 4.1 Solution Overview DELMIA Apriso Monitoring and Maintenance screens allow authorized personnel to make changes to the important system data (that influences production) called master data. If the system is configured to use a 21-CFR-Part-11-regulated environment, DELMIA Apriso always requires the user performing the changes to approve those changes using an Electronic Signature. This approval is enough for configurations of the Single Signature type. The changes performed by a user may also need to be approved by the user s supervisor. This approval is necessary for configurations of the Double Signature type, and the system will only modify data on the production environment after this approval. A limited number of screens in several data categories can be set to have Electronic Signatures enabled. A list of Monitoring and Maintenance screens supporting 21-CFR-Part- 11-regulated environment sis presented in 4.2 List of Supported Screens. In a 21-CFR-Part-11-regulated environment, each change to the data must be preceded by a checkout. The first signature is required before each check-in. The second signature action can be performed at a later time, but the change will not be effective nor will further changes be possible until it is approved by a supervisor (with the second signature). All the changes performed on the data before they are checked in and signed by a user (Single Signature) or signed by a supervisor (Double Signature) are stored in a special temporary location. A special Monitoring and Maintenance screen available for authorized personnel called Electronic Signatures is used to view the tracked changes to the system data (the Changelog, see Figure 6), to view/edit the currently locked data (with the Signature Lock Entity), and to approve/reject pending changes (Approval Cockpit). For details, see 4.4 Usage/Administration. Access to individual Monitoring and Maintenance screen grids can be configured via the Screen Security configuration by the System Administrator. In this way, individuals are assigned roles and become capable of (and responsible for) performing viewing, locking/unlocking, and accepting/rejecting changes. For details, see 4.3 Implementation/Configuration. Figure 6 Changelogs screen

13 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide List of Supported Screens Equipment Equipment (main editor) Resource Address (Links tab) Resource Contact (Links tab) Resource Group (Links tab) Child Resources (Links tab) Parent Resources (Links tab) Resource Life Cycle (Links tab) Resource Life Status (Links tab) Equipment Reason Codes (Links tab) Unit Characteristics (Links tab) Assigned Resources (Assignments tab) Maintenance Procedures (Maintenance tab) Safety Instruction Usage (Maintenance Procedure properties General tab) Resource Resource (main editor) Resource Group Child Resources Parent Resources Assigned Resources Resource Life Status Resource Life Cycle Equipment Reason Codes Resource Address Resource Contact Unit Characteristics Determination This relates to the Determination configuration screens accessed from Process Builder. Determination (main editor) Determination Elements (Input, Output, Key) Characteristic (Usage Type = Custom Attribute & Inspection) Characteristic (main editor) Attributes Reason Code/Group Groups Unit Characteristics Unit Attachments Specification

14 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 14 Specification (main editor) Specification Characteristics Attributes Unit Characteristics Unit Attachments 4.3 Implementation/Configuration Implementation of a 21-CFR-Part-11-regulated environment entails configuring the following: 1 Roles assign access rights to the Electronic Signature screen (and its elements). 2 Single/Double Signature decide whether it is enough that one person performs and signs the changes (Single Signature) or a supervisor needs to verify and approve/reject the performed changes. 3 Screens included decide which of the supported screens are to support Electronic Signatures. Configuration of 2 and 3 above can be mixed according to the requirements. Configuration is done through Central Configuration file which contains the keys for controlling if a 21-CFR- Part-11-regulated environment should be in force for a particular M&M screen category (data category): Resource Equipment Determination Characteristic Specification The above keys can have their values set to one of the following: Single Double None (this the default and means that no signatures are required) For details, refer to the ElectronicSignatures section of Central Configuration Documentation. Regarding point 3 above, configuration of roles is more advanced. By default, DELMIA Apriso is shipped with two roles connected to the 21-CFR-Part-11-related functionality: Approval Authority and Audit Reviewer. The following scenario illustrates the procedure for creating a sample employee with access to the Approval Cockpit (and only to the Approval Cockpit) as one of the Electronic Signatures screens: 1 Create a new employee and name it Jack Approver. 2 Link the Portal Administrator, Security Administrator, and Approval Authority roles to the new employee (in: Assignments tab Employee Roles) so that access to the Monitoring Tools, Electronic Signatures, and Approval Cockpit menu items is enabled, respectively. 3 In Screen Maintenance, it is necessary to configure the two remaining security screens so that they do not display any data but allow Jack Approver to exit them.

15 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 15 4 Select FlexNet.Maintenance.WinUI.Administration.Framework.SignatureLocked (of the List type) and enter its properties. 5 Create a new profile called ApprovalCockpitOnly, and make sure that the Available Columns list is empty on the Columns Available for Browsing tab. 6 On the Screen Commands tab, enable the Close command only. 7 Go to the Conditions tab and create a condition for the ApprovalCockpitOnly profile. 8 Link the Approval Authority role (the profile will be available for that selected role). 9 Repeat steps 4 8 for FlexNet.Maintenance.WinUI.Administration.Framework.ChangeLogBrowser screen. After signing in, Jack Approver should be able to access all three screens: Changelog Signature Lock Entity Approval Cockpit However, the user should only see empty browsers (with no grids) with the Close button when on the Changelog or Signature Lock Entity screens. 4.4 Usage/Administration Performing Changes to the Data (Single Signature) In order for the data to be editable on one of the screens subject to the 21-CFR-Part-11- regulated environment (listed in 4.2 List of Supported Screens), a checkout action needs to be performed. When the data is first checked out by a user, the system moves a copy of that data to a temporary location for that particular user and locks the data so that no other user can check it out. A single changelog file is also created in the system whenever a change is performed and saved to the data checked out by the user (the changlelog file is used for creation of the Changelog Report, as described in Viewing Changes to the System Data (Changelog). Both the temporary location data and the changelog are updated upon each save action performed on that screen, but the updates are not visible to anyone else until the data is checked in. The Check In action requires providing the credentials of the user performing the change and additionally allows for providing a reason code and a comment on this action (Figure 7).

16 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 16 Figure 7 Checking in the changes to an 21-CFR-Part-11-regulated screen If the system (with this particular screen) is configured to support Single Signature only, providing the required information is enough for the content to be moved from the temporary location to the production data, the changelog file to be closed and the lock to be released. If the system (with this particular screen) is configured to support Double Signature, the changed data will wait for the supervisor signature (as described in Approving/Rejecting Changes (Double Signature)) until it is performed on the production environment. The modified data stays locked for all users until the changes are approved or rejected, but the updated changelog file is available for the supervisor in this case. The changes that were not yet checked in can be discarded at any time (regardless of whether they were saved or not). The discard action will reset the data to its initial state while the data remains checked out. Additionally, from a single 21-CFR-Part-11-regulated screen, it is possible to view all the changes (via the Changelog Report) that were made on this particular set of data from the time it was first created (excluding those changes currently pending and not yet signed off on) Viewing Changes to the System Data (Changelog) The Changelog screen can be navigated to in the ADC. The screen allows authorized personnel to view all the changes that took place in the system in the form of a Changelog Report. The Changelog Report is displayed by selecting one or more records from the grid and clicking (Properties) or by double-clicking the desired record. The Changelog Report will present a compact printable form with all the necessary information about the changes, the users performing the signatures, etc. (see Figure 8). The Changelog Report detail level can be toggled using the report s Signature Stamp On, Changelog On, and Complex Data Off links in the top-right part of the screen.

17 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 17 Only those changes made to the data via Monitoring and Maintenance screens are captured by the Changelog Report as described here. If changes were made via, for example, a Process or Standard Operation (FI), the changes and the signature details are handled by DELMIA Apriso Audit as described in 2 Function Interpreter (DELMIA Apriso Runtime). Figure 8 Sample Changelog Report Viewing Locked Entities/Unlocking Locked Entities The Signature Locked Entity screen can be navigate to in the ADC. Whenever an entity is checked out for changes by a user, it is locked for editing until the changes are checked back in to the system and they are single- or double-signed. The Signature Lock Entity screen allows authorized personnel to view the signature actions that are currently pending and unlock them (that is, drop all the changes) when necessary. This ensures that no user blocks data for a long period of time. The Changelog Report for the pending changes can be displayed for records from this screen by clicking (Report). Clicking (Unlock) will break the lock for the selected record(s) and will clear the temporarily saved data (after a confirmation) as shown in Figure 9.

18 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 18 Figure 9 Signature Locked Entity screen Approving/Rejecting Changes (Double Signature) Approving and rejecting the changes made to the system data is possible only for those DELMIA Apriso screens configured to support Double Signature (for details, see 4.3 Implementation/Configuration) on the Approval Cockpit screen which can be navigated to in the ADC. The approval or rejection of a particular change can be done only via the intermediate Changelog Report, where the change can be reviewed (Figure 10). Only a single change (signature action) can be displayed per one Changelog Report for approval/rejection in the Approval Cockpit. When changes are approved by a Supervisor, the modified data is copied from the temporary location to the production environment, the temporary data is cleared, and the lock is broken so that other users can perform their changes. When the changes are rejected, the temporary data is cleared and the lock is broken.

19 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 19 Figure 10 Approval Cockpit screen

20 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 20 5 General Security Policy 5.1 Solution Overview Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management. 1 The DELMIA Apriso solution natively covers most of the requirements of 21 CFR Part 11 in terms of controls for identification codes/passwords. This area everything that is connected with the identity of the individual accessing DELMIA Apriso is described in the Security Implementation Guide. A few significant enhancements were added to DELMIA Apriso for full compliance with the FDA regulations. The identified features concern tracking and tracing any unauthorized access to the system: Logging all user attempts to access the system Identifying failed versus successful logins Notification on all failed attempts to access the system All the security events are tracked by DELMIA Apriso and saved in a dedicated table in the DELMIA Apriso database. All the places in DELMIA Apriso that perform security sensitive operations use special logic that captures the events. The log of all the events can be accessed by authorized personnel on the Security Log M&M screen (Figure 11). This functionality is described in detail in the Security Logging and Alerts section of the Security Implementation Guide. 1 Title 21 Food and Drugs, Chapter I Food and Drug Administration, Department of Health and Human Services, Subchapter A General, Part 11 Electronic Records; Electronic Signatures. In Sec Controls for identification codes/passwords. U.S Food and Drug Administration, April 1,

21 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 21 Figure 11 Security Log screen 5.2 Implementation/Configuration The personnel setting up the security policy should configure the system to use the access logging functionality (in a 21-CFR-Part-11-regulated environment) and to ensure that the proper users (roles) are notified of any suspicious attempts to access the system. DELMIA Apriso Central Configuration contains settings for controlling if and how the system should act in a 21-CFR-Part-11-regulated environment: The EnableAccessLog key in the SystemServices.Security section Multiple keys in the SystemServices.SecurityNotification section These keys are described in detail in the Central Configuration Documentation. 5.3 Usage/Administration Ongoing administration includes the monitoring and modification of notification policy whenever necessary. 5.4 Data Model The SECURITY_LOG table stores a log of all the security events. A description of the table as well as details on its fields are available in the Database Documentation.

22 21 CFR Part 11 Compliance DELMIA Apriso 2018 Implementation Guide 22 6 References All the documents referenced below are available from the DELMIA Apriso Start page, which can be accessed on your DELMIA Apriso server (<server name>/apriso/start). The newest versions of all the documents are available from the 3DS Support. 1 Dassault Systèmes, Security Implementation Guide This document gives an overview of DELMIA Apriso Security, providing the background information needed in order to effectively secure all instances of DELMIA Apriso. 2 Dassault Systèmes, Audit Trail Technical Guide This document provides an overview of the Audit Trail functionality used for configuring and tracking database changes within the DELMIA Apriso system. It describes how to perform common configuration and administration tasks. 3 Dassault Systèmes, Process Builder Online Help This online help provides an overview of DELMIA Apriso Process Builder and information on installing and using the application. It describes the user interface elements, entity maintenance, available Business Controls, and management of Processes, Operations, and Screen Flows. 4 Dassault Systèmes, Global Process Manager Online Help This online help describes the installation, configuration, and usage of DELMIA Apriso Global Process Manager (GPM). This application enables the full deployment of DELMIA Apriso solutions, regardless of their customization level, with support for both single- and multi-production server environments. 5 Dassault Systèmes, Database Documentation This documentation enables viewing DELMIA Apriso database (DB) tables (organized into groups), their descriptions, and the relations between them. 6 Dassault Systèmes, Business Components Documentation This documentation enables viewing DELMIA Apriso Business Components (BCs) and their descriptions. 7 Dassault Systèmes, Central Configuration Documentation This documentation describes in detail all the keys of the Central Configuration (CC) file for DELMIA Apriso. Various sections group the keys for individual modules or distinct functional areas.