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Electronic Lab Notebook for Biology Product Evaluation Phase 1 Mark Evans Tessella

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Grant Stephen: Chair of the MBC Life Science Informatics Group ... Focusses on issues affecting the long-term and legal authenticity of ELN data and records ... – PowerPoint PPT presentation

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Title: Electronic Lab Notebook for Biology Product Evaluation Phase 1 Mark Evans Tessella


1
The Fully Paperless ELN Challenges and
Approaches Mike Rippin Tessella Inc
Life Science Informatics Group

Grant Stephen Chair of the MBC Life Science
Informatics Group CEO, Tessella Inc
grant.stephen_at_tessella.com
Creating Insight Understanding from Scientific
Data
2
Introductions
  • Mike Rippin
  • michael.rippin_at_tessella.com
  • VP of Operations, Tessella Inc, Washington DC.
  • 12 Years as Consultant with Tessella working
    primarily in LifeSciences.
  • Consultant for eArchiving of ELN systems.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
3
Agenda
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
4
Agenda Scope
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
5
Scope
  • Look at what is common in all ELN systems in
    making the fully paperless transition
  • Does not cover detailed ELN features
  • Does not cover how to choose or install an ELN
  • Does not cover or recommend ELN products
  • Not specific to either Chemistry or Biology
  • Focusses on issues affecting the long-term and
    legal authenticity of ELN data and records

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
6
Agenda Setting the Scene
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
7
Background Laboratory Notebooks
  • A Cornerstone of Patents and IP
  • Laboratory notebooks are a cornerstone of a
    companies Patent applications
  • Concepts and Ideas
  • Chemical synthesis
  • Analytical and experimental properties
  • Heavily influenced by Legal and Regulatory
    requirements

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
8
ELN Background 101
  • Significant Benefits and Productivity Gains
  • Electronic Lab Notebooks have been available for
    several years
  • Aim is to replace the traditional paper
    notebook
  • Benefits
  • Productivity improvements
  • Cost savings
  • Analytical data integration
  • Data repurposing and enhanced science
  • Major players in Vendor market

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
9
ELN Background Early Challenges
  • ELNs had many problems to overcome
  • Technology Non standard technologies and
    infrastructures
  • Records Guaranteeing data/document authenticity
    and integrity
  • Regulatory Immature (and changing) Regulatory
    rules
  • Legal Basic Legal Admissability of electronic
    records in a court of law
  • ELNs are now standard operational tools

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
10
ELN Background What Next?
  • Rolling out a Lab Notebook is just the first step
  • The final steps of being fully paperless still
    eludes many
  • Implementation of electronic/digital signatures
  • AND
  • Implementation of long term electronic archives
  • Many implementations are a Hybrid of ELN and
    paper systems.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
11
Agenda Requirements of the paperless system
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the Paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
12
Requirements of the paperless system
  • Legal Equivalent of Paper LNB.
  • The fully paperless ELN is a system that
  • must provide the same legal status in
  • a court of law as a paper Lab notebook
  • It must provide the same degree of evidence as a
    paper LNB, including provision of supporting
    data.
  • It must provide electronic signatures that are
    the legal equivalent of wet signatures on paper.
  • It must provide the same long-term integrity and
    authenticity as a paper notebook does over many
    decades into the future.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
13
Requirements of the paperless system
  • Evidentiary Proof.
  • It must provide the same degree of evidence
  • as a paper LNB, including provision of
  • supporting data
  • This has always been a challenge for ELN
  • Definition of content
  • Layout and formatting
  • Descriptive language avoidance of ambiguities
  • Inclusion or otherwise of supporting data
  • Avoidance of any obsolescence traps hyperlinks

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
14
Requirements of the paperless system
  • Wet Signature Equivalence.
  • It must provide electronic signatures that
  • are the legal equivalent of wet signatures
  • on paper.
  • Unique Identity
  • Guarantee Authenticity and Integrity
  • Non-repudiation

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
15
Requirements of the paperless system
  • Long Term Accesibility and Readability
  • It must provide the same long-term integrity
  • and authenticity as a paper notebook does
  • over many decades into the future.
  • Data and records must be maintained for
    indefinite periods of time.
  • They must be accessible and readable at any point
    in the future.
  • They must preserve the essential characteristics.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
16
Agenda Field Experiences
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
17
Experiences in the Field
  • Significant efforts and progress are being made
  • Whos Doing What?
  • (based off top pharmas and biotechs)

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
18
Experiences in the Field
  • ELN Systems in Place
  • In-House development
  • CambridgeSoft
  • IDBS
  • PatentSafe
  • Architectures
  • Fully electronic
  • Hybrid (notebook, paper, microfiche)
  • Signing Approaches
  • Wet Signatures
  • Application proprietary electronic signatures
  • SAFE Strong Digital Signatures

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
19
Experiences in the Field
  • Storage Formats
  • Paper
  • Microfiche
  • PDF
  • Storage Environments
  • Internal Warehouse
  • Iron Mountain (Paper LNBs)
  • ELN Storage media
  • Documentum
  • In-House RM systems
  • Long Term Preservation Strategies
  • None

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
20
Experiences in the Field
  • Issues Lack of corporate policies and direction
  • Common Issues and Challenges
  • ELN Initial major business process change from
    LNB?ELN
  • Organizational
  • Pulling together diverse stakeholders
  • Lack of corporate policies for long term
    archiving
  • Inconsistent involvement of Records Management
  • Lack of corporate/centralized policies for
    electronic signatures
  • Lack of Legal direction on Admissable Records
  • Archiving Multiple siloed implementations for
    storage and archiving
  • Signatures Diverse implementations for
    electronic/digital signatures

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
21
Agenda Digital Signatures
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
22
Digital Signatures - Recap
  • Recap why we need them!
  • Essential component in going paperless
  • Replace wet signatures in LNB with electronic
    signatures in ELN
  • Legal need on record admissability drive
    requirements on signing technology
  • Must guarantee the identity, authenticity and
    integrity of the signer and signed documents

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
23
Digital Signatures - Types
  • There are different types of electronic
    signature that provide successively better
    degrees of assurance
  • Electronic signature means a computer
    data compilation of any symbol or series of
    symbols executed, adopted, or authorized by an
    individual to be the legally binding equivalent
    of the individual's handwritten signature.
  • Digital signature means an electronic
    signature based upon cryptographic methods of
    originator authentication, computed by using a
    set of rules and a set of parameters such that
    the identity of the signer and the integrity of
    the data can be verified.
  • Digital Signatures are the current best
    technology for Legal Equivalence.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
24
Digital Signatures the Law
  • Global laws not consistent on acceptance of
    Digital Signatures as absolute equivalents of wet
    signatures
  • EU DIRECTIVE 1999/93/EC OF THE EUROPEAN
    PARLIAMENT AND OF THE COUNCIL basically states
    that Digital Signatures (conforming to certain
    rules) should be admissable in court as the
    equivalent of wet signatures.
  • US There is no such strong equivalent in the US
  • A 2000 E-Sign Act gives electronic signatures
    legal validity but no mandate.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
25
Digital Signatures How do they work?
MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
26
Digital Signatures SAFE
  • SAFE Signatures and Authentication For Everyone
  • Non-profit association. Created and manages the
    SAFE-BioPharma digital identity and signature
    standard.
  • Mission to be the digital identity and
    signature standard for the global
    biopharmaceutical and healthcare communities.
  • Many Pharmaceutical companies are members.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
27
Agenda Digital Archiving
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
28
Digital Archiving What is it?
  • Long term, managed, record preservation
  • Not just Backup.
  • Not just Storage on a digital media.
  • Managed framework for the guaranteed long-term
    preservation of electronic records that combats
    obsolescence.
  • Non-operational environment.
  • System must evolve over the retention period of
    records to guarantee access and authenticity.
  • This is a long-term undertaking and commitment.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
29
Digital Archiving OAIS Framework
  • Open Archival Information System
  • ISO Standard 14721

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
30
Agenda Issues and Challenges
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
31
Summary of Issues and Challenges
  • Organizational
  • Diverse stakeholders getting them in same room
    and agreeing and buy in
  • Global cross site integration
  • System re-use
  • Business process changes scientists records
    managers
  • Existing ELN best practice

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
32
Summary of Issues and Challenges
  • Legal Regulatory
  • Input at all levels of system requirements and
    specification
  • Different laws in different countries
  • Regulatory 21 CFR 11

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
33
Summary of Issues and Challenges
  • Signatures
  • Electronic signature technology
  • Is SAFE an option?
  • Do we sign data or documents
  • Do we embed signatures in documents or keep them
    separate
  • How often in the ELN experiment lifecycle should
    we sign
  • Do we sign just an Experiment summary or the
    archival package of supporting data as well?

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
34
Summary of Issues and Challenges
  • Archiving
  • Short, medium and long term strategy
  • Archival centralization at corporate level
    avoiding silos
  • Archival frameworks
  • Corporate preservation strategies
  • Data formats and standardization
  • Meta-data definition (and open standards)
  • Retention periods
  • Human readable renditions - microfiche

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
35
Summary of Issues and Challenges
  • Archival Record generation
  • Structure and content of ELN record
  • Audit recording and inclusion
  • Accessory data inclusion in archive
  • Archival Format
  • PDF or PDF/A or ODF or Other?
  • Scientific formats JCAMP, ANIML
  • Archival Package construction.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
36
Agenda Implementation Strategy Roadmap
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
37
Implementation Strategy Roadmap
  • Understand the system component breakdown
  • Identify the important characteristics of each
    component
  • Understand the business requirements you have for
    the system and make key decisions on the issues
    outlined earlier
  • Understand the technologies and components
    available to you already
  • Construct a solution mapping implementation
    details to system components using best practise
    and advice

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
38
Implementation Strategy Roadmap
  • Understand the system component breakdown

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
39
Implementation Strategy Roadmap
  • Identify the important characteristics of each
    component

Source ELN Must satisfy research
requirements Provide interface API Provide access
to data fragments 21CFR11
Creates Experiment Summary And/Or Archival package
Open format Preservation friendly format Human
readable Open standard meta-data description
Existing technology Open interface for system
integration Security, Access and Roles Multiple
signature generation
Digital Signatures 3rd Party Certfication
Short term Existing technology Security, access
and roles
Corporate system Long term evolution/
preservation strategy
MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
40
Implementation Strategy Roadmap
  • Understand and finalize the business requirements
    you have for the system
  • For example
  • What policies and procedures are in place that
    affect or impose upon the requirements
  • We will use SAFE Digital Signatures
  • We will sign an archival rendition of the ELN
    experiment
  • We will sign and witness every 7 days
  • We will include Analytical data in the archive
  • Etc etc

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
41
Implementation Strategy Roadmap
  • Understand the technologies and components
    available to you already
  • For example
  • What signing technology does your organization
    have in place
  • What workflow tools exist
  • What systems could be used as short term record
    storage
  • What systems could be used as long term archival
    storage
  • What would need to be purchased/built?

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
42
Implementation Strategy Roadmap
  • Construct a solution which maps implementation
    details to system components using best practise
    and advice
  • For Example

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
43
Implementation Strategy Roadmap
1 ? 2 ? 3
  • 3 Phase Implementation
  • Phase 1 (The Past) Implement ELN according to
    business need. May lead to Hybrid approach.
  • Phase 2 (The Present) Implement a Paperless
    system using a local short-medium term storage
    medium, possibly locally managed. System must
    still meet all requirements for ensuring record
    integrity and authenticity and is not a hack
    solution.
  • Phase 3 (The Future) Migrate to a long term
    digital archive. This is likely to be a
    corporate environment.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
44
Implementation Strategy Roadmap
  • Key Points
  • Involve all stakeholders at the planning and
    design stage including Legal, Records
    Management, and the scientists
  • Understand your ELN Business Rules and Processes
    such that they will support the generation of
    long-term ready records
  • Understand what systems your organization can
    already provide you aim for corporate/global
    system consolidation
  • Use Strong Digital Signature technology
  • Agree with Legal what constitutes your ELN
    Record
  • Use open standards for meta-data (METS, XIP,
    PREMIS) and for documents and data PDF/A, XML,
    TIFF etc
  • Devise an evolutionary implementation strategy
    that allows you to put in place the paperless
    environment while delaying the detailed
    implementation of the final archive.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
45
Agenda Summary
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
46
Summary
  • ELN are increasingly important.
  • Good progress made in moving towards the
    paperless environment.
  • Legal Acceptance and standardization around
    Digital Signatures.
  • The long term archival components are still
    missing
  • Consider your implementation roadmap carefully.

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
47
Agenda Questions?
  • Scope of Presentation
  • ELN Background Setting the Scene
  • Requirements of the paperless system
  • Experiences In the Field
  • Digital Signatures
  • Digital Archiving
  • Summary of Issues Challenges
  • Implementation Strategy Roadmap
  • Summary
  • Questions?

MBC Fully Paperless ELN Challenges and
Approaches 5th February 2009
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