Grant Stephen: Chair of the MBC Life Science Informatics Group & CEO, Tessella Inc:...

Grant Stephen: Chair of the MBC Life Science Informatics Group& CEO, Tessella Inc: [email protected]

Creating Insight & Understanding from Scientific Data

Life Science Informatics Group

The Fully Paperless ELN Challenges and Approaches

Mike Rippin Tessella Inc

Mike Rippin [email protected]

• VP of Operations, Tessella Inc, Washington DC.• 12 Years as Consultant with Tessella working primarily in

LifeSciences.• Consultant for eArchiving of ELN systems.

Introductions

MBC: Fully Paperless ELN – Challenges and Approaches – 5th February 2009

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


Agenda – 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

Scope



Agenda – Setting the Scene


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

Background – Laboratory Notebooks


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

ELN Background – “101”


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

ELN Background – Early Challenges


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.

ELN Background – What Next?


• 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

Agenda – Requirements of the paperless system


“Legal Equivalent of Paper LNB.”

The fully paperless ELN is a system thatmust provide the same legal status in a court of law as a paper Lab notebook:

1. It must provide the same degree of evidence as a paper LNB, including provision of supporting data.

2. It must provide electronic signatures that are the legal equivalent of wet signatures on paper.

3. It must provide the same long-term integrity and authenticity as a paper notebook does – over many decades into the future.

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



“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



“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.




Agenda – Field Experiences


Significant efforts and progress are being made

• Who’s Doing What*?

• *(based off top pharmas and biotechs)

Experiences in the Field


Company ELN e-Sig Archive/Storage FormatP1 In House Solution Wet Signature Paper --> MicroficheP2 CambridgeSoft ELN for Chemistry Wet Signature PaperP3 In House Solution PatentSafe (Amphora) PatentSafe (Amphora)P4 In House Solution for Chemistry ELN PatentSafe (Amphora) PatentSafe (Amphora)

In House Solution for Chemistry ELN SAFE Digital Signature e-Archive (PDF and Flatten PDF)Biology ELN -- IDBS SAFE Digital Signature (?)

P6 Customized vendor Solution SAFE Digital Signature PDF and MicroficheP7 CambridgeSoft ELN CambridgeSoft e-Signature PDFP8 CambridgeSoft ELN for Chemistry CambridgeSoft e-Signature PDFP9 CambridgeSoft ELN for Chemistry SAFE PDFP10 CambridgeSoft ELN for Chemistry SAFE PDF, Flatten PDF and MicroficheP11 In house Paper (plan to use SAFE on ELN) Paper P12 CambridgeSoft ELN CambridgeSoft e-Signature PDFP13 CambridgeSoft ELN for ChemistryP14 In house solution EMC Documentum for e-Sig MicroficheP15 CambridgeSoft ELN for Chemistry CambridgeSoft e-Signature PDF

P5

• 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



• 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



Issues – Lack of corporate policies and direction

• Common Issues and Challenges• ELN: Initial major business process change from LNBELN• 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




Agenda – Digital Signatures


• 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

Digital Signatures - Recap


• 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.

Digital Signatures - Types


• 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.

Digital Signatures – the Law


• 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.

Digital Signatures – SAFE


http://www.safe-biopharma.org/index.htm


Agenda – Digital Archiving


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.

Digital Archiving – What is it?


Digital Archiving – OAIS Framework


• Open Archival Information System• ISO Standard 14721


Agenda – 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

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





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?



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



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.

Agenda – 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

Implementation Strategy & Roadmap


• Understand the system component breakdown



ELN

Record Renderer

Signing Workflow Manager

Digital Signer

Document Storage

Author

Witness

Experiment Record

Long Term

Archive

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.



1 2 3

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”.



Agenda – 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.

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?

Agenda – Questions?


Grant Stephen: Chair of the MBC Life Science Informatics Group & CEO, Tessella Inc:...

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