Professional Documents
Culture Documents
April 2012 Microsoft Corporation Health and Life Sciences Industry Unit Paragon Solutions Health and Life Sciences Practice
Draft SharePoint Configuration Guidance v0.9j Table of Contents Introduction ..................................................................................................................... 4 Acknowledgements ......................................................................................................... 6 Architectural Approaches to Compliance ......................................................................... 7 Use Cases for 21 CFR Part 11 Compliance .................................................................... 9 Electronic Signature Use Cases .................................................................................. 9 Single Signature Use Case ...................................................................................... 9 Multiple Signature Use Case ................................................................................. 10 Digital Signatures Use Cases .................................................................................... 11 Single Signature Use Case .................................................................................... 11 Multiple Signature Use Case ................................................................................. 11 User Authentication Use Case ............................................................................... 12 Architecture for 21 CFR Part 11 Compliance ................................................................. 13 Windows Server 2008 R2 .......................................................................................... 13 Active Directory Domain Services ............................................................................. 13 Active Directory Rights Management Server ............................................................. 13 Active Directory Certificate Services .......................................................................... 14 What is XAdES? .................................................................................................... 14 Time stamping and XAdES-T signatures ............................................................... 15 Active Directory Federation Services ......................................................................... 15 SQL Server 2008 R2 ................................................................................................. 16 SharePoint Designer ................................................................................................. 16 SharePoint 2010 Architecture for Compliance ........................................................... 16 Database Security ..................................................................................................... 17 Configuring the Electronic Signature Use Cases ........................................................... 19 Administrator Configuration for Single Signatures ..................................................... 19 Configure document library templates ................................................................... 19 Configure Document Library Version Histories ...................................................... 22 Configure Document Templates for Workflow and Signatures ............................... 23 Create workflows for electronic signatures............................................................. 26 Create a Signature Page ....................................................................................... 33 Set Policies for the Document Library .................................................................... 35 Configure Document Templates for Workflow and Multiple Signatures .................. 41 Create workflows for multiple electronic signatures ............................................... 44 Create a Signature Page ....................................................................................... 51 Set Permissions for the Document Library ............................................................. 51 Set Policies for the Document Library .................................................................... 52 Digital Signatures Use Case.......................................................................................... 52 Administrator Configuration for Digital Signatures ..................................................... 52 Configure Document Library Templates ................................................................ 52 Configure Document Library Version Histories ...................................................... 53 Configure Document Templates for Workflow and Digital Signatures .................... 53 Create workflows for digital signatures .................................................................. 56 Add or Change a Collect Signatures Workflow ...................................................... 56 Add or change a Collect Signatures workflow for a library or content type ............. 56 Start a Collect Signatures workflow on a document or workbook ........................... 58 Create a Signature Page ....................................................................................... 59 Set Permissions for the Document Library ............................................................. 59 Set Policies for the Document Library .................................................................... 59 View the Version Histories for Digital Signatures ................................................... 59 2
Draft SharePoint Configuration Guidance v0.9j 21 CFR Part 11 Requirements ...................................................................................... 62 Subpart B Electronic Records ....................................................................................... 63 11.10 Controls for Closed Systems ........................................................................... 63 11.10 (a) Validation of Systems ............................................................................. 63 11.10 (b) Record Review and Inspection ............................................................... 65 11.10 (c) Records protection and retrieval ............................................................. 65 11.10 (d) System Access ....................................................................................... 66 11.10 (e) Audit Trail ............................................................................................... 68 11.10 (f) Operational System Checks .................................................................... 68 11.10 (g) Protect records from unauthorized access .............................................. 68 11.10 (h) Data Input Validation .............................................................................. 69 11.10 (i) Training ................................................................................................... 69 11.10 (j) Electronic Signature Policy ...................................................................... 69 11.10 (k) System control ........................................................................................ 70 11.30 Controls for Open Systems ......................................................................... 71 11.50 Signature Manifestations ............................................................................ 72 11.50 (a) Signature Manifestation .......................................................................... 72 11.50 (b) Control of signature information .............................................................. 72 11.70 Signature/Record Linking ........................................................................... 73 Subpart C Electronic Signatures ................................................................................... 73 11.100 General Requirements ............................................................................. 73 11.100 (a) Uniqueness .......................................................................................... 73 11.100 (b) Identity Verification ............................................................................... 74 11.100 (c) Legal Certification ................................................................................. 74 11.200 Electronic Signature Components and Controls............................................. 74 11.200 (a) Non-biometric Signatures ..................................................................... 74 11.200 (b) Biometric Signatures ............................................................................ 75 11.300 Controls for Identification Codes/Passwords ............................................ 75 11.300 (a) Uniqueness of identity .......................................................................... 75 11.300 (b) Password Policy ................................................................................... 75 11.300 (c) Deactivation of Users ............................................................................ 76 11.300 (d) Unauthorized use of passwords or identification codes ........................ 76 11.300 (e) Identification Code Device Testing ....................................................... 77 Systems Validation and Compliance ............................................................................. 78
Introduction
Since the release of the Microsoft Office SharePoint Server 2007, compliance has been a major focus of the Microsoft Office System. That focus continues with SharePoint 2010 and includes additional functionality that further enhances compliance capabilities. In addition to the audit trails and document level security that were introduced in SharePoint 2007, there are now enhanced capabilities for document and records compliance. These enhanced features include: Records center document libraries can be placed anywhere in a site collection In-place records management in any document library Centrally managed and distributed content types and taxonomies Centrally managed policies and workflow enforced on content types Workflow can promote a document from loose collaboration to a formally declared and managed record, including the capability for electronic signatures. Multi-stage records disposition Centralized audit trails and audit trail reporting that is easily configured with no additional coding necessary.
While these features can be applied to a broad range of regulations, including SarbanesOxley and HIPAA, they also apply to 21 CFR Part 11. Thus the Microsoft Office SharePoint Server 2010 when combined with other Microsoft technologies, including Active Directory, Information Rights Management, and (optionally) the Microsoft PKI system, provides a system that may be configured to assist with 21 CFR Part 11 compliance. In a departure from previous whitepapers on the topic, we approach this document a bit of a different way: 1. Describe the overall SharePoint architecture needed to support compliance a. Including both conceptual and product-level architectures 2. Provide a set of use cases for compliance and then detail the configurations necessary to support those use cases. 3. Provide a mapping between 21 CFR Part 11 and the configurations detailed as part of the use cases that support each individual line of the regulation. This approach will be more useful for those involved in the validation effort as it provides the use cases and then the configurations necessary for validation. Of course, software cannot be compliant by itself, so SharePoint 2010 and other Microsoft technologies must be used in conjunction with a broader compliance framework, including appropriate configurations, policies, procedures and validation documentation that are the responsibility of the implementing party.
Draft SharePoint Configuration Guidance v0.9j Disclaimer The information contained in this document represents the current view of Microsoft Corporation on the issues discussed as of the date of publication. Because Microsoft must respond to changing market conditions, it should not be interpreted to be a commitment on the part of Microsoft, and Microsoft cannot guarantee the accuracy of any information presented after the date of publication. This White Paper is for informational purposes only. MICROSOFT MAKES NO WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, AS TO THE INFORMATION IN THIS DOCUMENT. Complying with all applicable copyright laws is the responsibility of the user. Without limiting the rights under copyright, no part of this document may be reproduced, stored in or introduced into a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise), or for any purpose, without the express written permission of Microsoft Corporation. Microsoft may have patents, patent applications, trademarks, copyrights, or other intellectual property rights covering subject matter in this document. Except as expressly provided in any written license agreement from Microsoft, the furnishing of this document does not give you any license to these patents, trademarks, copyrights, or other intellectual property. 2011 Microsoft Corporation. All rights reserved. Microsoft, Microsoft Office 2010, Microsoft SharePoint 2010, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Rights Management Services, Active Directory, Windows Server 2008 R2, Windows 7, Windows Vista, Windows XP, Microsoft Windows, Microsoft Certificate Lifecycle Manager, Microsoft Visual Studio, Microsoft Forefront are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.
Acknowledgements
As with any effort of this size, there are a myriad of persons involved in its development. In this case, the efforts of Paragon Solutions (http://www.consultparagon.com) in the development of the demonstration system, SharePoint configurations, workflows, SharePoint Designer configurations and sample source code, all of which were absolutely essential for this project to be successful. It is also necessary to acknowledge the Life Sciences Industry Unit members who wrote and reviewed the configuration text, the use cases, regulation interpretation and guided the development of the end product. Finally, it is necessary to acknowledge the efforts of the Microsoft Consulting Services on the 2007 version of this whitepaper, portions of which remain intact especially in the section that maps each part of 21 CFR Part 11 to the needed configuration step.
Foundational ECM
Document Management Records Management Web Content Management Rich Media Managment Document Output Human Centric Workflow E-Mail Archiving*
Equally matched by the capabilities Foundational ECM capabilities in SharePoint are the plethora of partners that embrace and extend the SharePoint platform. These include vendors that provide out-of-the-box Part 11 and GxP compliance, vendors that provide capabilities for scientists through electronic lab notebooks and LIMS systems, even vendors that provide manufacturing and plant floor monitoring capabilities all on SharePoint. These are in addition to the workloads listed in the graphic above. For the purposes of Part 11 compliance, we will be looking at the features that Microsoft categorizes as Records Management. For planning Records Management systems, the implementer will need to factor in a couple key considerations: Policies & Workflow File & Archival Plan In-Place Records vs. Centrally Archived Managed Metadata and the Taxonomy Term Store
Managed Metadata and the Taxonomy Term Store provide more flexibility to the end user as well as the system administrator when it comes to Metadata. Users are no longer simply consigned to setting the metadata through dialog boxes at upload time, but can actually set the metadata for a document during the authoring process. Similarly, 7
Draft SharePoint Configuration Guidance v0.9j content managers have the ability to manage the metadata, through hierarchical means, and propagate those terms throughout a site collection. The decision whether to use in-place records or centrally archived records becomes crucial when configuring the system for Part 11 compliance. In this document, the workflows and configurations demonstrate both approaches, by using in-place records for most electronic and digital signature workflows, but then using a central archive record store once a documents lifecycle has run its course. Policies and workflow are central to configuring SharePoint 2010 for compliance with any regulation. In this whitepaper we will discuss at length the use of workflow for electronic and digital signatures, as well as the use of policies to determine which documents need signatures. Given those key considerations, the balance of this document will be split into two parts: 1. A discussion of configuring SharePoint 2010 for Part 11 compliance a. Utilize a Use Case methodology so the document can be used providing guidance for your own validation efforts b. Provide the architecture to support the Use Cases c. Detail the workflow and policies for electronic signatures d. Detail the workflow and policies for digital signatures e. The promotion of records to in-place and centrally managed records 2. Mapping 21 CFR Part 11 to the areas of the previous use case to demonstrate how SharePoint meets those regulations
Note: This system details use of an optional embedding of the signature into the Word Document, providing a visible record in the document itself of the signature process. The user will: Navigate from the their project page to the document management library for that project View the documents currently in process and the workflow status of each document 9
Draft SharePoint Configuration Guidance v0.9j Author the document to make necessary changes Save the document to the library Submit the document for workflow approval Sign the document as part of the approval workflow View the audit trail (workflow history) of the document library
Note: This system details use of an optional embedding of the signature into the Word Document, providing a visible record in the document itself of the signature process. Each signing user will: Navigate from the their project page to the document management library for that project View the documents currently in process and the workflow status of each document Author the document to make necessary changes Save the document to the library Submit the document for workflow approval Sign the document as part of the approval workflow View the audit trail (workflow history) of the document library
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These configurations will enable the user to: Navigate from the their project page to the document management library for that project View the documents currently in process and the workflow status of each document Author the document to make necessary changes Save the document to the library Submit the document for workflow approval Sign the document in Office 2010 client Save the document to the document library as part of the workflow View the audit trail (workflow history) of the document library
Draft SharePoint Configuration Guidance v0.9j Create workflows for Digital Signatures o Utilize SharePoint Designer o Attach the workflow to the document library Set the policies for the document template o Create custom security for the content-type o Set permissions on the content-type so that regulated documents cannot have the version history changed
The user will: Navigate from the their project page to the document management library for that project View the documents currently in process and the workflow status of each document Author the document to make necessary changes Save the document to the library Submit the document for workflow approval Sign the document in Office 2010 client Save the document to the library as part of the workflow View the audit trail (workflow history) of the document library
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Draft SharePoint Configuration Guidance v0.9j policies, which remain with the information, no matter where it is moved. You can use AD RMS to help prevent sensitive information such as clinical trial reports, site monitoring documentation or even e-mails from intentionally or accidentally getting into the wrong hands. In SharePoint 2010 this is configured through the Information Rights Management (IRM) screen which can be applied at the document library or document library template level. It is important to note that users do not have to have Office installed to read protected documents and messages. SharePoint 2010 with Web Applications understands rights management, so any user with access to a browser and rights to the document can view the document. It is also important to note that users do not need to reside within your organization, as long as they are granted appropriate rights. Any user with a Hotmail account or a LiveID can be granted access to a document and then able to view it through a SkyDrive account or through e-mail.
What is XAdES?
XAdES (XML Advanced Electronic Signatures) is a set of tiered extensions to XML-DSig, the levels of which build upon the previous to provide more and more reliable digital signatures. By implementing XAdES, Office complies with the European Union Advanced Electronic Signature Criteria in Directive 1999/93/EC as well as a new Brazilian government directive which defines XAdES as the accepted standard for digital signing in Brazil. Office 2010 can create different levels of XAdES signatures on top of XML-DSig signatures:
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Once everything is configured, you can just create signatures like you normally would. A timestamp from a trusted timestamp server extends the life of your signature, because even after the certificate expires, the timestamp proves that the certificate had not expired at the time of signing. As a result, time stamping protects against certificate expiration, and if the certificate was revoked after the signature was applied, the signature is still valid.
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Draft SharePoint Configuration Guidance v0.9j organizations are free to collaborate, participate in workflow and even execute electronic or digital signatures in both organizations SharePoint sites.
SharePoint Designer
SharePoint Designer is the mechanism the IT Professionals and Power Users can use to create workflows, design custom pages and other tasks that are not available in the SharePoint interface itself.
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Certificate Services
While the overall architectural components are important, it is also key to identify proper organization, sizing of the server farm, navigation and other concepts. Those elements are largely outside scope of this document. For information on the concepts of sizing, navigation and geographical disbursement, please visit http://msdn.microsoft.com as well as http://www.microsoft.com/itshowcase for best practice information on SharePoint implementation on an enterprise scale.
Database Security
21 CFR 11.10(d) notes that access to IT applications must be limited to authorized individuals. In addition to internal safeguards built into a computerized system, external safeguards and policies should be put in place to ensure that access to the computerized system and to the data is restricted to authorized personnel. Staff should be kept thoroughly aware through training and procedures of system security measures and the importance of limiting access to authorized personnel. Procedures and controls should be put in place to prevent the altering, browsing, querying, or reporting of data via external software applications that do not enter through the protective system software. IT guidelines, standard operating procedures and controls typically ensure that access to back-end servers and applications is controlled. There is a potential security issue where a person with elevated permissions to the WSS-Content-Database could alter records in the database table and impact the Signed 17
Draft SharePoint Configuration Guidance v0.9j Person, Date signed, and Purpose of Signing tables. Per typical IT operating measures, people with elevated permissions are typically authorized and working under strict operating procedures. The likelihood of malicious changes is low. However, if someone did alter the underlying database tables, SharePoint will not recognize these changes; hence the signature would become invalidated. If this is viewed as a security issue not handled well enough by internal IT operating procedures, there are options. To fix this issue, an encryption key can be generated and stored in the document library. This key would be used to determine if changes were made to the document properties using SQL update. A hash key can be generated using the following columns from the document library: Signer Name Purpose of Signing DateTime (of signing) Version of the Document Document Status A timer service can run to check approved documents to see if any changes were made in the WSS-Content-Database. The encryption key is examined, and any changes noted will invalidate the document. If the document is found to be invalid, a workflow will be invoked to send an email to the signer and/or an administrator to note that the document has been changed by an unknown person and hence the document is invalid. There are other options for achieving this level of check and balance to ensure that a malicious activity at the database level is discovered and accounted for. However, for most organizations internal IT operating procedures preclude unauthorized access to servers and applications.
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Once in the target document library, click on the Library Tab in the Ribbon Bar. This brings you to the Document Library Settings page which enables you to add the necessary columns for electronic signatures. Navigation Steps to Add Columns: To add columns in the document library Click Library Tools > Library > Document Library Settings and Create columns
The following columns will be added: Username Purpose of Signature Document Status (needed for workflow processing) Date Signed Signers
To add columns in the document library Click Library Tools > Library > Document Library Settings and Create columns
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After adding the necessary columns, while still in the Document Library Settings, click on Versioning Settings. This brings you to Document Library > Document Library Settings > Versioning Settings screen which enables you to control the versioning for the document library. 21
Click Yes under Require content approval for submitted documents Click Create major versions, or other settings as needed by your companys policies and procedures.
Once you click Submit for the Versioning Settings screen, you will be returned to Document Library > Document Library Settings screen. This turns on the "audit trail functionality, which allows users to be able to view the audit trail of the system through simple reports. In the Document Library those changes can be reflected in the document view itself on a document by document basis.
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For Centralized Audit Reporting, and administrator would need to turn on this feature under > Site Actions > Site Settings > Site Collection Audit Settings.
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In Document Library > Document Library Settings > Advanced Settings Screen click Edit Template in the Document Template section under the Template URL: dialog.
This will launch the template editor in Microsoft Word. Click on the Insert tab in the Ribbon Bar. On the Insert Tab, click on the Quick Parts > Document Property dialog and pull-down.
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Draft SharePoint Configuration Guidance v0.9j Drag and drop the fields DateSigned, DocumentStatus, PurposeOfSignature, Username and other fields added to the document library to support electronic signatures.
This then results in a document that has a signature line added in through metadata. Note that this document, once signed, can be protected via Rights Management Service so that it cannot be modified once signed, even if e-mailed or a thumbdrive used to copy the document elsewhere. Once Rights Management has been set up for a SharePoint site, setting rights on any given document is as simple as having the document inserted or created in a document library with specific rights. Those permissions or rights - are then inherited by all the documents in that library, or items in a list. This means that with the appropriate rights set on the document library, as shown in this document, you have the ability to lock down documents with or without a formal records declaration and prevent those documents from being changed by those without permissions.
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To create an electronic signature workflow, click on the Workflows link under Navigation>Site Objects. 27
Once the workflow tab is open, click on the Workflows tab in the Ribbon Bar, then click on the List Workflow button.
To configure the workflow for the electronic signature document library, click on the appropriate document library name in the List Workflow pull-down.
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In creating the workflow, the first step is to add condition checks for Approval Status. This will use the Content Approval Status Column in the list library. This condition check will determine if the document is Approved, Rejected, or if the document is already signed.
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You can then define the e-mail message that can be sent to the users involved in the workflow. This is configured through steps during the SharePoint design Workflow creation process. (see define e-mail Message below) 30
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Note, again, that the document, when placed into a library can inherit the permissions and Information Rights Management Policies through RMS. Since RMS is not an inherently necessary part of Part 11 compliance, please see the MSDN documents on the topic.
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Full source code for all the functions will be provided as an appendix to this whitepaper. Using the provided source code, the signature page appears as follows.
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Draft SharePoint Configuration Guidance v0.9j Though not required, as the signature is stored with the document in SharePoint, it is a nice touch that helps users know that a signature has been applied to a given document. Thus, in the solution provided, code was added to append the signature to the document itself. In addition, the document is protected by rights management as part of the workflow cycle, so that no changes can be made to the document once signed.
It is important to note that this is still an electronic signature and not a digital signature. The configuration methods for digital signatures are provided later in the document. Set Permissions for the Document Library SharePoint 2010 has the ability to set permissions on the Document level, Document Library level and site level. To set permissions for a document library, Navigate to your document library > click on Library > Library Permissions
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To add stage properties for a document library goto Document library settings > Information Management Policy Settings
Click Change Resource link to change staging properties for the documents library
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On clicking the hyper link Add Retention stage the below popup will be shown to configure the document into Records Center. Note that the Content Organizer can also be used to send records into the records center that are subject to Part 11 compliance based on their content-type.
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Once delivered to its final destination after approval, the document is automatically declared a record.
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Navigate to > Site Actions > Site Settings > Record Declaration Settings for globally setting this throughout the site.
The last step in the process is creating the Custom Permission Levels for Site Roles, so Versioning, Content Approval Settings, and Workflow cant be manipulated.
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Draft SharePoint Configuration Guidance v0.9j This is an important consideration for Part 11 compliance, as it assures with proper configuration that the audit histories, electronic signatures and other vital information for compliance is not changed in any fashion.
This configuration of SharePoint and workflow has all records transferred to their preferred locations via the records retention policies based on the Signed Doc attribute. When the Document becomes approved, then the attribute is set as a record inside the workflow. To see more on the process of transferring signed documents to the records center, please see http://technet.microsoft.com/en-us/library/ee424395.aspx
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Once in the target document library, click on the Library Tab in the Ribbon Bar. This brings you to the Document Library Settings page which enables you to add the necessary columns for electronic signatures. The following columns will be added, which include the single signature columns as well as additional columns for multiple signatures: Username Purpose of Signature Document Status (needed for workflow processing) Date Signed Signers Additional fields as outlined below.
The steps for setting version history and version control are the same as for creating single electronic signatures.
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In Document Library > Document Library Settings > Advanced Settings Screen click Edit Template in the Document Template section under the Template URL: dialog.
This will launch the template editor in Microsoft Word. Click on the Insert tab in the Ribbon Bar. On the Insert Tab, click on the Quick Parts > Document Property dialog and pull-down. Drag and drop the fields DateSigned, DocumentStatus, PurposeOfSignature, Username and other fields added to the document library to support electronic signatures.
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This then results in a document that has a signature line added in through metadata. Note that this document, once signed, can be protected via Rights Management Service so that it cannot be modified once signed, even if e-mailed or a thumbdrive used to copy the document elsewhere.
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To create an electronic signature workflow, click on the Workflows link under Navigation>Site Objects.
Once the workflow tab is open, click on the Workflows tab in the Ribbon Bar, then click on the List Workflow button.
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To configure the workflow for the electronic signature document library, click on the appropriate document library name in the List Workflow pull-down.
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In creating the workflow, the first step is to add condition checks for Approval Status. This will use the Content Approval Status Column in the list library. This condition check will determine if the document is Approved, Rejected, or if the document is already signed.
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You can then define the e-mail message that can be sent to the users involved in the workflow. Go to Actions > Send an Email and Confgure properties approprately
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Again, it is important to note that while not necessary for Part 11 compliance, the use of Rights Management Service in conjunction with SharePoint will ensure that the rights become part of the document itself, originally applied as part of workflow or when a document is loaded into the document library.
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Draft SharePoint Configuration Guidance v0.9j The instructions for updating SharePoint for Information Rights Management can be found on MSDN.
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Draft SharePoint Configuration Guidance v0.9j As with the electronic signatures, you first select the document library that will be used for the Digital Signatures. When there, click on the Library Tools > Library tab in the Ribbon Bar. This brings you to the Document Library Settings page which enables you to add the necessary columns for digital signatures. The following column will be added: Document Status (needed for workflow processing) Date Signed Signers
In Document Library > Document Library Settings > Advanced Settings Screen click Edit Template in the Document Template section under the Template URL: dialog.
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This will launch the template editor in Microsoft Word. The first step in adding a digital signature to the document is by going to the Office 2010 BackStage by clicking on the File tab in the Ribbon Bar. Then under Protect Document click on Add Digital Signature.
Once the Digital Signature is added, youll want to navigate to the section of the document that will contain the signature. To insert the Signature at that location, Click on the Insert tab in the Ribbon Bar. Click on the Signature Line drop down.
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This will enable you to insert a signature block or multiple signature blocks. In addition, this drop down provides for multiple signature providers. This enables different certificates. Once inserted, an unsigned signature block or multiple blocks looks as such:
The signature block can also be a stamped signature, such as would be done for a SAFE BioPharma logo.
In Signing a document, the user is prompted for Comment which is generally used as the Purpose for Signing. It is also possible to create a custom signature event, such as one for SAFE BioPharma that is located at http://www.codeplex.com/safe Once used by the signer, the signature block appears as such:
Note that digitally signing a document also makes that document read-only. Saving the document and making any changes invalidates and removes the signature (but not the unsigned signature block) from the document.
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Draft SharePoint Configuration Guidance v0.9j Also important to discuss is the role of Rights Management, which can be applied to a document before the signature process, further protecting the document from change.
Draft SharePoint Configuration Guidance v0.9j 1. To go to the Add a Workflow page or the Change a Workflow page for the library or content type to which you want to add a workflow, do one of the following: o For a library: 1. Open the library to which you want to add or change a workflow. On the Settings menu library that you are opening. , click the settings for the type of
For example, in a document library, click Document Library Settings. 2. Under Permissions and Management, click Workflow settings. o For a list content type: 1. Open the library that contains the instance of the list content type for which you want to add or change a workflow. On the Settings menu library that you are opening. , click the settings for the type of
For example, in a document library, click Document Library Settings. 2. Under Content Types, click the name of the content type. o
For a site content type: 1. On the home page for the site collection, on the Site Actions menu , point to Site Settings, and then click Modify All Site Settings. 2. Under Galleries, click Site content types. Click the name of the site content type for which you want to add or change a workflow, and then click Workflow settings.
NOTE If workflows have already been added to this library or content type, this step takes you directly to the Change Workflow Settings page, and you need to click Add a workflow to go to the Add a Workflow page. If no workflows have been added to this library or content type, this step takes you directly to the Add a Workflow page. 3. On the Change Workflow Settings page, click Add a workflow or click the name of the workflow for which you want to change the settings. Do one of the following: If you are adding a workflow, on the Add a Workflow page, in the Workflow section, click the Collect Signatures workflow template.
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Draft SharePoint Configuration Guidance v0.9j If you are changing the settings for a workflow, on the Change a Workflow page, change the settings that you want to change according to the following steps. In the Name section, type a unique name for the workflow. In the Task List section, specify a tasks list to use with this workflow. NOTES You can use the default Tasks list or you can create a new one. If you use the default Tasks list, workflow participants will be able to find and view their workflow tasks easily by using the My Tasks view of the Tasks list. If the tasks for this workflow will reveal sensitive or confidential data that you want to keep separate from the general Tasks list, you should create a new tasks list. If your organization will have numerous workflows or if workflows will involve numerous tasks, you should create a new tasks list. In this instance, you might want to create tasks lists for each workflow. In the History List section, select a history list to use with this workflow. The history list displays all of the events that occur during each instance of the workflow. NOTE You can use the default History list or you can create a new one. If your organization will have numerous workflows, you might want to create a separate history list for each workflow. In the Start Options section, specify how, when, or by whom a workflow can be started. NOTES Specific options may not be available if they are not supported by the workflow template that you selected. The option Start this workflow to approve publishing a major version of an item is available only if support for major and minor versioning is enabled for the library and if the workflow template that you selected can be used for content approval. If you are adding this workflow to a site content type, specify whether you want to add this workflow to all content types that inherit from this content type in the Update List and Site Content Types section. NOTE The Update List and Site Content Types section appears on the Add a Workflow page only for site content types. Click OK.
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Draft SharePoint Configuration Guidance v0.9j 2) Point to the document or workbook on which you want to start a Collect Signatures workflow, click the arrow that appears, and then click Edit in Program Name.If the document or workbook does not already contain signature lines to capture the digital signatures that you want to collect, insert them now as described previously and repeated below.If you add new signature lines, click the File Tab, and then click Save to save your changes.If the document is checked out, you must also check in the document before you start the workflow. To check in the document, click the File Tab, point to Server, and then click Check In.For the user go start the workflow, click the File Tab, and then click Workflows.In the Workflows dialog box, locate the Collect Signatures workflow that you want to use, and then click Start.In the Workflow Name dialog box, type the names of the people you want to sign the document on the appropriate signers lines, or click Signer to select people from the directory service.If you want to assign the signature tasks in the order in which signature lines appear in the document, select the Request signatures in the order above, rather than all at once check box.If you want other people to receive notifications (not task assignments) when the workflow is started, type their names on the CC line, or click CC to select people and groups from the directory service.Click Start.Create a Signature Page Starting with Office 2007 and continuing with Office 2010, Signature Pages for Digital Signatures are out-of-the-box. To sign a document, right click on the Signature Block as shown above, select the certificate to be used, provide the reason for signing, and click OK. You will be prompted for your Digital Certificate PIN and/or to insert your SmartCard or Token. Once the PIN is authenticated against the card or token, the signature is placed within the document and the document is made read-only. The only change that can be made to a signed document is to add another signature.
2. Click the File tab. The Microsoft Office Backstage view opens. 3. Click the Info tab. 4. Click View Signatures. 5. The Signatures pane appears with a list of signatures. The following image is an example of the Signatures pane.
In the Signature pane, next to the signature name, click the down arrow and select Signature Details. The Signature Details dialog appears. Click See the additional signing information that was collected. The Additional Information dialog appears. The following image is an example of the Additional Information dialog.
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What the signature signs Local date and time the signature was applied The version of the Microsoft Windows operating system installed The version of Microsoft Office installed The version of the Microsoft Office program used The number of monitors installed Monitor resolution
You can view the message that indicates the file is not showing hidden content
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Operational Qualification begins with the development methodology utilized to create the software. Most Microsoft products, and all the products detailed in this whitepaper, adhere to the Security Development Lifecycle methodology. This methodology, which encompasses steps traditionally employed in software development methodology, places a particular focus on development of software that is secured by design, in development, and through implementation. All major software releases from Microsoft, beginning with the Office 2007 and Vista/Longhorn wave of software releases are required to go through the internal processes and checkpoints detailed in the Security Development Lifecycle methodology, and must be signed off on by a Security Officer before the particular software can be released to the general public. The details of the methodology are available on MSDN as well as through published works by Steve Lipner and Michael Howard (see the Reference section for more information). In addition, there is a whitepaper available entitled Mapping Microsoft Development Methodology to the V-Model that is available on MSDN as well. Operational Qualification extends to the operation of the software. To that end, most Microsoft software, and all the products detailed in this whitepaper, provide detailed error logging and troubleshooting information that can be gained through a proper implementation of the Microsoft Systems Center Operations Manager. In fact, any software release must include a management pack for Operations Manager before the particular software can be released to the general public. The details of the management pack for all relevant software are available in the References section of this document. Performance Qualification always includes the question -- Does the software perform to the end users needs? As that question can only be answered by the implementing party, the final step in validation of the software needs to be the development of test plans and testing of the software in the environment in which it will be utilized. These test plans can be modeled on this whitepaper to assist with the proper configuration of the software. While the overall validation of the software is up to the implementing party, Microsoft has assisted in the validation through the creation of the development methodology, implementation of management packs, implementation of the installation logs, and development of this whitepaper to give guidance in the configuration of the software and development of the test plans for performance qualification. Finally, Microsoft recommends that companies periodically audit their own implementation of the software, in order to ensure that the guidelines specified herein are applied to their production systems and are enforced throughout. To address validation of the individual documents, SharePoint provides auditing features to facilitate the validation process. As SharePoint server is designed as an auditable system, the administrator can configure the system to audit document creation, specifically document modification and 64
Draft SharePoint Configuration Guidance v0.9j deletion among other things so all changes to a document are audited. Additionally, you can also extend the auditing capabilities to include additional information such as version and workflow status. All these capabilities related to SharePoint were demonstrated in the configurations detailed in the use cases section of this Whitepaper
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Draft SharePoint Configuration Guidance v0.9j 1) Automatically receive/route records declared from other sourcesRecords Centers are able to determine how the Content Type of a declared record translates to an appropriate record series in the file plan, and then file the record into the appropriate location. 2) Hold ordersThe Records Center includes a powerful hold order system to locate records relevant to particular event requiring a hold order, suspending disposition of those records for the duration of the event, and for resuming normal disposition once those events have ended. 3) Separate access controlsRecords Center can give you the flexibility to specify whether users can access any section of the Records Center, whether they can view or add items, independent of the permissions those users have on authoring and collaboration sites. As demonstrated, documents can be attached to a policy that defines content expiration and version control policy. Microsoft Office technology allows content that is outside the repository to be secured on the basis of policies as well by using the Rights Management Server. With the 2010 system, an access control policy set up for a SharePoint site can also be maintained for documents on the desktop. These rights also extend to expiration, printing, forwarding, and copying, thereby ensuring a higher level of content security than has been possible with traditional approaches.
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Draft SharePoint Configuration Guidance v0.9j The following is a sample web.config file used to setup forms-based authentication, rolebased access, and denies access to unauthenticated users: <configuration> <connectionStrings> <add name="MySqlConnection" connectionString="Data Source=MySqlServer;Initial Catalog=aspnetdb;Integrated Security=SSPI;" /> </connectionStrings> <system.web> <authentication mode="Forms" > <forms loginUrl="login.aspx" name=".ASPXFORMSAUTH" /> </authentication> <authorization> <deny users="?" /> </authorization> <membership defaultProvider="SqlProvider" userIsOnlineTimeWindow="15"> <providers> <clear /> <add name="SqlProvider" type="System.Web.Security.SqlMembershipProvider" connectionStringName="MySqlConnection" applicationName="MyApplication" enablePasswordRetrieval="false" enablePasswordReset="true" requiresQuestionAndAnswer="true" requiresUniqueEmail="true" passwordFormat="Hashed" /> </providers> </membership> <roleManager defaultProvider="SqlProvider" enabled="true" cacheRolesInCookie="true" cookieName=".ASPROLES" cookieTimeout="30" cookiePath="/" cookieRequireSSL="false" cookieSlidingExpiration="true" cookieProtection="All" > <providers> <add name="SqlProvider" type="System.Web.Security.SqlRoleProvider" connectionStringName="MySqlConnection" applicationName="MyApplication" /> </providers> </roleManager> </system.web> </configuration> 67
After authentication, the user will also need to be assigned appropriate rights to access specific features and contents. Details on how to configure user roles and rights are discussed in Section 11.10 (g) of this paper.
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Draft SharePoint Configuration Guidance v0.9j Creating a successful Records Management system starts with mapping out the organizations records management goals, anticipating the challenges an organization will face in making that vision a reality within the company, and developing a policy and implementation that fits these needs. Since planning is a key to both the policy development and solution implementation phases, it is important to outline the challenges faced at each stage so these can be kept top of mind when working out both the organization policy plan and implementation strategy. At the policy planning stage, the major challenge is to devise a system that encompasses an organizations current records-keeping needs: content types, media types, storage requirements, business processes, and policies. It also needs to meet present legal and audit requirements, and be extensible and flexible enough to accommodate future content types and retention requirements. Another important goal is to enhance information retrieval, which will help employees do their jobs more efficiently and give an organization a competitive advantage. In developing the policy for an organization, the challenge is to create an overarching policy document that is comprehensive but short, easy to read, and accompanied by actionable retention schedules that can then be put into practical use. Furthermore the policy needs to be integrated with the organizations other enterprise content management policies, and be able to absorb and integrate previous record keeping efforts. At the implementation stage, the major challenge is to create a system that suits the organizations workflow, one that will actually be adopted by users and integrated into their daily activities. The implementation must be simple enough for employees to grasp quickly, easy enough to require only few extra steps (or clicks), but rigorous enough to meet the organizations overall need for record keeping within the organization. Furthermore, any technology rollout must be manageable for the organization as a whole and not significantly disrupt normal business operations. SharePoint Server 2010 includes multiple information management policy features to help an organization manage content type as shown in Section 11.10 (c): Document expiration Document auditing Document labels Document bar codes
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How Office 2010 System and Rights Management Services (RMS) address the requirement
Microsoft Active Directory Rights Management Services (RMS) augments an organizations security strategy by providing protection of information through persistent usage polices, which remain with the information. Content is protected with RSA 1024bit Internet encryption and authentication so that information will be safe in transit and will remain with the document, no matter where it goes. For example, encrypted content stored on a lost USB drive will not be accessible and viewable to any unauthorized viewer, regardless of location. This information protection technology works with RMSenabled applications to help safeguard digital information from unauthorized useboth online and offline, inside and outside of the firewall. Record managers and administrators can define exactly how users can use data and can place limitations on who can open, modify, print, copy, and forward certain confidential information. Revision and change control can be enforced through checkout and audit trail policies as discussed previously in this document.
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Draft SharePoint Configuration Guidance v0.9j affect the on-page content of a document, but can be viewed and verified with software, including Office 2010 applications. In Document Signature Signing an Office document in a special signature line object that visually shows who signed the document. This feature is designed to mimic the experience of pen and ink signatures. It is this type of signature that was created in the earlier configuration of electronic signatures discussion.
As discussed, Office 2010 documents support digital signatures out of the box and are extensible. For digital signature of non-office based documents, there is 3rd party vendor support in the market place. In addition to the digital signature controls and SSL used to transmit the electronic record, Forefront Security for SharePoint can provide further assurance that the record is valid by protecting Microsoft Office SharePoint Server 2010 servers from viruses, unwanted files and inappropriate content.
Draft SharePoint Configuration Guidance v0.9j the document in SharePoint; are kept with and linked to the document throughout the document life cycle; and can be viewed with the document in SharePoint. As demonstrated, it is possible to integrate the metadata into the body of the document, as it would appear in a printed version of the document, through the use of a document template that reads the metadata from SharePoint, stores the metadata in the document as part of the OpenXML, and then allows for display of the metadata inline in the document.
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Draft SharePoint Configuration Guidance v0.9j The creation, maintenance, and authentication of the user are discussed in Section 11.300 Controls for Identification Codes / Passwords.
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Draft SharePoint Configuration Guidance v0.9j (3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.
11.300
Persons who use electronic signatures based upon the use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include the following:
Similar policies can be extended to Digital Certificates through the use of Microsoft Active Directory Certificate Services.
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This whitepaper is available on MSDN at the Microsoft Life Sciences Developer Center (http://msdn.microsoft.com/architecture/lifesciences).
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