Electronic Lab Notebook for Biology Product Evaluation Phase 1 Mark Evans Tessella - PowerPoint PPT Presentation

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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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