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www.arkgenllc.com 323.332.0926 [email protected] ELECTRONIC LAB NOTEBOOK IM PLEM ENTATION ARKGEN CONSULTING 2017 W HITE PAPER
www.arkgenllc.com 323.332.0926 [email protected]
ELECTRO N IC LA B N O TEBO O K IM PLEM EN TATIO N
ARKGEN CONSULTING
2017
WHITE PAPER
ELECTRONIC LAB NOTEBOOK
Electronic Laboratory Notebook, ?ELN?, provides an electronic alternat ive to paper-based laboratory notebooks. It electronically captures and maintains the information required for documenting experiments in an organized and flexible fashion.
Electronic laboratory notebooks are becoming an increasingly popular tool for research and rout ine laboratories as part of a way to opt imize work flow and minimize cost while realizing t ime-saving benefits. The number and variety of available solut ions are quickly increasing; making select ion of the right notebook a cumbersome process.
The ability to create, share, search and query research and development (R&D) data in real-t ime, offers any organizat ion with the opportunity to transform the research process with improved efficiency and enhanced collaborat ion in a secure, easy-to-use environment.
ELN IM PLEM EN TATIO N
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OUR CLIENT
Our client is a global health care company with a 125-year history of working to make a difference. Our client 's business is focused on innovat ion and scient ific excellence to deliver vaccines, medicines, and animal health products that can help millions around the world, in the areas of diabetes, infect ious diseases, oncology, and vaccines.
The purpose of Electronic Lab Notebook implementat ion is to provide scient ists with a streamlined process of electronically searching and retrieving the clients? Intellectual Property (IP), generated externally by Contract Research Organizat ions (CRO) and other external partners.
ELN IM PLEM EN TATIO N
www.arkgenllc.com [email protected]
www.arkgenllc.com [email protected]
CURRENT CHALLENGESPaper laboratory notebooks (PLN) are becoming the bott leneck in laboratory information management, they pose many issues and challenges in life science laboratories, some of the crit ical issues are,
CONTINUITYThe problem of data loss and knowledge transfer is especially notable if a researcher leaves the laboratory.
INFORMATION LOSSLoss of information is a major issue of laboratory records that are not being digit ized and stored in a systematic way.
DATA RETENTIONPLN have problems keeping up with growing amount of data produced, demand for its traceability and reuse
ELN IM PLEM EN TATIO N
If It 's Not Writ ten Down, Then It Didn't Happen!.
AUDIT TRAILStringent audit t rails can also pose serious issues if the record retent ion is not at par with regulatory guidelines
REGULATORY AND LEGAL CHALLENGESElectronic lab notebooks used for development or research in regulated industries, such as medical devices or pharmaceuticals, are expected to comply with FDA regulat ions related to software validat ion. The purpose of the regulat ions is to ensure the integrity of the entries in terms of t ime, authorship, and content. Typical provisions related to software validat ion are included in the medical device regulat ions at 21 CFR 820 (et seq.)[1] and Tit le 21 CFR Part 11.[2] Evidence to show that this is the case is often provided by a Software Requirements Specificat ion (SRS) sett ing forth the intended uses and the needs that the ELN will meet; one or more test ing protocols that, when followed, demonstrate that the ELN meets the requirements of the specificat ion and that the requirements are sat isfied under worst-case condit ions. Finally, one or more reports demonstrat ing the results of the test ing in accordance with the predefined protocols are required prior to release of the ELN software for use.
Sources
https://spl ice-bio.com/
1. United States. Food and Drug Administr ation. Depar tment of Health and Human Resources. 1 Food and Drugs - Subchapter H Medical Devices - Par t 820 System RegCode of Federal Regulations - Ti tle 2ulation. FDA.gov, 7 Oct. 1996.
2. United States. Food and Drug Administr ation. Depar tment of Health and Human Resources. Code of Federal Regulations - Ti tle 21 Par t 11 Electronic Records; Electronic Signatures. FDA.gov. Author i ty: 21 U.S.C. 321-393; 42 U.S.C. 262., 20 Mar. 1997. Web. 16 Nov. 2011
323.332.0926
ARKGEN'S SUPPORTOur competent resource acted as trusted business advisor and a cert ified Project Management personnel to assist the client through the integrat ion effort . We followed tradit ional SDLC methodology with Six Sigma Methodology (DMADV) for the ELN system implementat ion and other process improvements.
Our high level deliverables specific to this project are summarized as following,
4. SDLC STATE DIAGRAMS- Current State Diagrams- Current State Process- Future State Diagrams- Future State Processes
5. PILOT EFFORTSAs a Part of Six Sigma Methodology, documented Pilot Efforts for all the external partners and external sites
6. EXHAUSTIVE TEST STRATEGY1.Performance Test ing2.Development Test ing3. Installat ion Test ing for TEST Env4.Core Acceptance Test ing5. Installat ion Test ing for UAT Env6.User Acceptance Test ing7. Installat ion Test ing for PROD Env
1. SDLC DOCUMENTATIONDetailed Requirement Specificat ion, Design Specificat ion and Funct ional Specificat ion documents
3. CHANGE MANAGEMENT PLANDetailed Change Plan with Task/Deliverables List for each of the three phases of ELN Implementat ion
2. BUSINESS ANALYSISDetailed Impact Analysis including Business, Technical And Compliance Impact Analysis
ELN IM PLEM EN TATIO N
7. SIX SIGMA DELIVERABLES1.Process Maps2.Project Charter3.SIPOC4.RAPIDX5.Voice of The Customer6. Impact Effort Matrix7.Wighted Criteria Matrix8.PDCA/PDSA9.Pilot Check List10.Control Plan
8. TRAINING MATERIALDetailed ELN related Training Programs for external partners
ArkGen?s support in ELN integrat ion effort reduced the documentat ion effort required by external partner scient ists, improved accuracy in reference to other scient ific work, and provided better integrat ion of information across clients? research act ivit ies.
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