[EN] "Electronic Records Management: Why re-invent the wheel?" | Presentation | Christoph Jeggle | PROJECT CONSULT | 01.12.2009
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"Electronic Records Management: Why re-invent the wheel?" | Presentation | Christoph Jeggle | PROJECT CONSULT | 01.12.2009 Topics - Why Reinvent The Wheel? - Key Processes of RM - Types of Standards - Metadata - Data Formats - Generic Standards - ISO 15489 - MoReq2 - Selected Functional Requirements - Summary - MoReq2 compared to 21 CFR Part 11 The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
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[EN] "Electronic Records Management: Why re-invent the wheel?" | Presentation | Christoph Jeggle | PROJECT CONSULT | 01.12.2009
- 1. Electronic Records Management: Why re-invent the wheel ? Christoph Jeggle, Senior Consultant PROJECT CONSULT
- 2. www.diahome.org The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Disclaimer
- 3. www.diahome.org Why Reinvent The Wheel? • (Electronic) Records Management is regulated by many standards Are these standards useful for implementation and operation of (E)RM in the pharmaceutical industry?
- 4. www.diahome.org Key Processes of RM RECORDS
- 5. www.diahome.org …Covered by Standards RECORDS Moreq2 ISO 15489 XML Metadata: DC, ISAAR, ISOs 23081, 2788, 5964 ISO 18492, OAIS X.509, XKMS ISO 12142 ISO 15801, 12654 ISO 12033 PDF/A RFC 2821, 2822, TIFF, JPEG ISO 216 ISO 12037 GUID PDF/A ISO 15801, 12654
- 6. www.diahome.org Types of Standards • Terminology • Procedures and Methods • Metadata • Data Formats • Interfaces
- 7. www.diahome.org Example 1: Metadata RECORDS Moreq2 ISO 15489 XML Metadata: DC, ISAAR, ISO 23081 ISO 2788 ISO 5964 ISO 12142 ISO 15801, 12654 ISO 12033 PDF/A RFC 2821, 2822, TIFF, JPEG ISO 216 ISO 12037 GUID ISO 15801, 12654
- 8. www.diahome.org Metadata Standards DC Dublin Core ISAAR International Standard Archival Authority Record for Corporate Bodies, Persons, and Families ISO 23081 Information and documentation -- Records management processes -- Metadata for records ISO 2788 Documentation -- Guidelines for the establishment and development of monolingual thesauri ISO 5964 Documentation -- Guidelines for the establishment and development of multilingual thesauri
- 9. www.diahome.org Example 2: Data Formats RECORDS Moreq2 ISO 15489 XML Metadata: DC, ISAAR, ISOs 23081, 2788, 5964 ISO 18492, OAIS X.509, XKMS ISO 12142 ISO 15801, 12654 ISO 12033 PDF/A RFC 2821, 2822, TIFF,JPEG ISO 216 ISO 12037 GUID PDF/A ISO 15801, 12654
- 10. www.diahome.org Generic Standards RECORDS MoReq2 ISO 15489 XML Metadata: DC, ISAAR, ISOs 23081, 2788, 5964 ISO 18492, OAIS X.509, XKMS ISO 12142 ISO 15801, 12654 ISO 12033 PDF/A RFC 2821, 2822, TIFF, JPEG ISO 216 ISO 12037 GUID PDF/A ISO 15801, 12654
- 11. www.diahome.org ISO 15489 • Definition of meaning, function and elements of Records Management Systems Limited value for implementations of Records Management Systems
- 12. www.diahome.org MoReq2 • Model Requirements for the management of electronic records – Prepared for the European Commission – Reviewed also by pharmaceutical organisations • National Agency for Medicines, Finland • Royal Pharmaceutical Society of GB
- 13. www.diahome.org MoReq2 • First version published in 2001 • Second version published in 2008 – adaption to the impact of technological changes – introducing independent compliance testing
- 15. www.diahome.org MoReq2 Requirements • Terminology and key requirements • Functional requirements • Non-functional requirements • Metadata Requirements
- 16. www.diahome.org MoReq2 – Functional Requirements • Core Requirements – Classification scheme and file organisation – Controls and security – Retention and disposition – Capturing and declaring records – Referencing – Searching, retrieval and presentation – Administrative functions
- 17. www.diahome.org MoReq2 – Functional Requirements • Optional Requirements – Management of Physical (Non-electronic) Files and Records – Disposition of Physical Records – Document Management / Collaborative Working – Workflow – Casework
- 18. www.diahome.org MoReq2 – Functional Requirements • Optional Requirements (continued) – Integration with Content Management Systems – Electronic Signatures – Encryption – Digital Rights Management – Distributed Systems – Offline and Remote Working – Security Categories
- 19. www.diahome.org MoReq2 - Terminology • Generic terminology, not adapted to the pharmaceutical industry • User-centred, not technical terminology
- 20. www.diahome.org MoReq2 – Key Concept
- 21. www.diahome.org Selected Functional Requirements • Concept for complex records (several components linked to each other) • Physical records including hybrid records • Vital records
- 22. www.diahome.org Selected Functional Requirements • Audit Trail • Reason for changes
- 23. www.diahome.org Selected Functional Requirements • Electronic Signature – Advanced electronic signature according European „Directive on an Community Framework for Electronic Signatures“ 1999/93/EC
- 24. www.diahome.org Selected Functional Requirements • Disposal holds • Logical and/or physical deletion • Metadata stub after destruction
- 25. www.diahome.org How To Use MoReq2? Functional requirements as repository for User Requirement Specification – Very detailed, describing all options – Using MoReq2 terminology Copy and Paste from MoReq2 to URS not recommended
- 27. www.diahome.org MoReq2 Metadata • Comprehensive metadata model • Includes all elements of the MoReq2 specification • Detailed description of all metadata elements • Including XML schema
- 28. www.diahome.org How To Use MoReq2? Good starting point for enterprise-wide metadata model
- 30. www.diahome.org MoReq2 Compliance Testing • Test Framework for MoReq2 • Structured as a set of testing modules corresponding with the requirement modules • Including test data
- 31. www.diahome.org How To Use MoReq2? Testing framework usable as test script
- 34. www.diahome.org Summary • MoReq2 – Detailed specification of • requirements, • metadata and • compliance testing – Closely related to each other
- 35. www.diahome.org MoReq2 compared to 21 CFR Part 11 21 CFR Part 11 MoReq2 Open vs. closed system - Electronic record Component, document, record Digital signature Electronic signature Electronic signature - Audit trail Audit trail Validation - Training -
- 36. www.diahome.org How To Use MoReq2? • Requirements, metadata and test frameword together usable for – Records Management system • selection, • implementation • validation
- 37. www.diahome.org MoReq2 – Current Situation • Certification – Until now: Only one RM product certified • Fabasoft Folio 2009 (Austrian manufacturer) • Chapter 0 (national requirements) – Until now: Only available in the French translation
- 38. www.diahome.org MoReq2 Links • http://www.moreq2.eu/ • http://ec.europa.eu/transparency/archiv al_policy/moreq/index_en.htm
- 39. www.diahome.org Thank you for your attention Christoph Jeggle christoph.jeggle@project-consult.com http://www.project-consult.com
Editor's Notes
- Records Management is part of an area called as Enterprise Content Management abbreviated as ECM. Other parts are Document Management, Web Content Management, Workflow and Business Process Management. Records Management is one of the areas of ECM which is described in detail by standards. The question of this presentation is: Is there a useful standard available for Records Management? Of course standards are always more or less useful but practically useful is not so often. So I have to precise the question: Is there a standard practically useful in the specific area of the pharmaceutical industry?
- Which standards are available for Records Management? Because most of the standards related to records management cover only parts of records management. Most of the parts here are self explaining. But it could be helpful to explain transfer and manage. Transfer means the exchange of records between organisations and manage the management of access and of other parameters like document types, retention time and so on.
- And this is the coverage of the areas by standards. I have limited time in this presentation. Therefore I skip the explanation of the particular standards.
- But I would like to classify the types of standards. Every standards belongs to one or more types of standards. Some standards are more focused on the explanation of terminology in records management. Other standards describes procedures and methods in records management. The metadata standards are important for the exchange of records and the long time preservation. As well as the data formats which are a continuous challenge for long time preservation. Records management is not isolated but integrated in other systems and applications. Therefore interfaces are subject of standardization.
- Let’s have a look at some types of standards and their representation.
- A typical metadata standard is the Dublin Core. But thesauri are also subject of standardization (ISO 2788 and 5964).
- Data formats are also subject of standardization. PDF/A is nowadays an accepted format for long time preservation. But precondition has been that this format is no longer a proprietary data format. Now PDF/A and PDF itself is a standard. But more appropriate to long time preservation is PDF/A for example requiring the embedding of fonts into the PDF document.
- Two standards are generic and not focused on a particular area of records management. These standards are ISO 15489 and MoReq2.
- ISO 15489 defines the meaning, function and elements of records management systems. It is helpful for developing a common understanding of records management. But the value for the implementation of records management systems is limited.
- Another standard is MoReq2. MoReq means Model Requirements for the management of electronic records. This requirement document has been prepared by Serco Consulting. This is a company from UK.
- The first version of MoReq was published in 2001. MoReq2 is a new version from 2008. This new version adapts the requirements to the impact of technological changes and introduces independent compliance testing. That means products can be tested against the requirements using a test script which is part of MoReq2.
- The documentation of MoReq2 consists of three parts: the requirements itself, the metadata structure compliant to the requirements and the already mentioned compliance testing.
- I would like to begin with the requirements. This part of MoReq2 starts with terminology and key requirements followed by functional and non-functional requirements and metadata requirements.
- The functional requirements are separated into core and optional requirements. The core requirements cover all areas of records management. Beginning with the classification over capturing, retention, searching and retrieval. Of course access control and administrative functions are also core requirements. Referencing as a core requirement might not be so self explaining. It means the usage of identifiers for the classification and unique identifiers for the each element in the classification scheme and the records itself. So the location of the record inside the classification scheme is fully described by the classification identifier, in most cases a combination of numbers. Every element in the classification scheme for example class or file is uniquely identified by a system identifier. Also records have unique system identifier.
- The optional requirements contain functions which are either not directly related to records management in the proper sense or more focused on physical records. This shows that MoReq is a requirement document for electronic records management. Physical records are not in the focus of the requirement document.
- On the other side some of the optional requirements are not unimportant for the pharmaceutical industry. For example electronic signatures appears as a interesting requirement. We have to discuss it later on.
- Let‘s start with the terminology after this short overview over the functional requirements of MoReq2. The terminology is generic. It is not adapted to any specific industrial terminology including pharmaceutical industry. And it is not a technical terminology. The requirements are defined from the users point of view. The following description of the key concept demonstrates it clearly.
- The classification scheme consists of classes. Classes may contain files. Files are not the files in the technical meaning as a file on the hard disk. File means a logical folder. This file may be divided into sub-files or volumes. Records are stored in classes, files, sub-files or volumes. Records are formed of one or more documents and have record types. Record types define the retention and disposition schedule. Records and documents are made up of components. This is the MoReq concept of record classification which is flexible and near to the organization of physical records, for example the concept of volumes. Following I would like to select some functional requirements which should be interesting in the usage of records management in the pharmaceutical industry.
- MoReq2 considers the fact that records consist of complex content. For instance submission or application records consist of several documents which are linked to each other. This structure must not be impacted by the records management. Also a common situation in the pharmaceutical industry is the situation of coexistence of electronic and physical records. Complex records might consist of both. This is called hybrid record. Vital records are interesting concepts. It means the marking of records as vital for the business continuity. Such records should be preferable in case of disaster recovery.
- MoReq2 requires functionality well known in the pharmaceutical industry: audit trail including the documentation about the reason of changes.
- The next selected functional requirement looks familiar: the electronic signature. Unfortunately the meaning of electronic signature in MoReq2 and for instance in Part 11 is contrary. I will explain it later in the comparision of part 11 and MoReq. Electronic signature in MoReq2 means the advance electronic signature according the directive of the European Union.
- Further important requirements are the possibility of disposal holds in case of legal actions which prohibit the disposal of records and the differentiation between logical and physical deletion. Logical deletion marks the metadata of a record as deleted. This deletion could be revoked. The physical deletion means the deletion on the storage medium. This can not be revoked. In some cases it is required to document the existence of deleted documents. This is a common requirement in some areas of the pharmaceutical industry. Leaving a stub after deletion fulfills this requirement.
- After this short explanation of some interesting requirements in MoReq2 it is now the question: What is the practical use of MoReq2? How can MoReq2 be used? MoReq2 is a generic requirement specification which can be used as repository for user requirements. On the one hand the description of the requirements is very detailed and therefore describes all options given in a requirement. On the other hand the description is MoReq like using the MoReq terminology. Therefore it is not recommended to use MoReq2 as a repository in the meaning of copy and paste.
- I would like to show an example of a functional requirement in MoReq2. This example describes all options of a system behavior in case of searching for a document without the appropriate permission to access. All four options are reasonable possibilities of behavior. Now the author of the user requirements has to select the option most appropriate to the security standards in the company. But you can see also that the MoReq terminology is used. By the way: It is quite helpful that the requirements are explained (italic characters).
- Now the next element of the MoReq2 content: the metadata. MoReq provides a comprehensive metadata model which is in line with the requirements. All elements of the metadata modell are described in detail. You will see an example later on. Additionally MoReq2 provides a XML scheme for the metadata model.
- Again the question: How to use MoReq2? The MoReq metadata model is a good starting point for an enterprise-wide metadata model. Of course it has to be adapted to specific needs but it is really comprehensive.
- And here is the already mentioned example. I would like to emphasize a detail in this metadata description. In the last row of the table you can see the list of requirements related to this metadata element. 4.1.23 is the example shown before. The metadata element keyword is related to the requirement.
- The next element of the MoReq2 content is the testing. MoReq2 provides a set of testing modules corresponding with the requirement modules. The test framework includes even test data.
- Therefore the test framework is usable as test script for implementations of records management to be tested.
- Also the test case is related to the requirement. In this example you see the test case related to our requirement mentioned before. The test case checks the possibility to configure the options for search results in the case of missing permissions to access
- I hope the examples before clarify that the content of MoReq2 requirements, metadata and compliance testing are firmly connected to each other.
- So far so good. But what is about Part 11? Do the MoReq requirements meet the Part 11 ones?
- This table compares some Part 11 key concepts with MoReq2. MoReq2 does not distinguish between open and closed systems. The electronic record in the meaning of Part 11 is covered by several concepts in MoReq2. The electronic signature in Part 11 is not covered by MoReq2. The electronic signature in MoReq2 matches the digital signature in Part 11. This is the main difference in the concepts. The concept of audit trail is similiar in both documents. Validation and training is not covered by MoReq2
- A summary: The good news is that MoReq is usable in the pharmaceutical industry. It supports the selection, implementation and validation of records management systems.
- The bad news is: MoReq2 is not widely used until now. Only on records management product is certified. And the chapter 0 which is the chapter for nation specific requirements is only available in French. Nevertheless it makes sense to use MoReq2 as specification supporting activities in records management, also in the pharmaceutical industry.
- You will find the documentation in these web sites for free.