Technological survey on LIMS and ELN in Life Sciences - Biogenouest

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them have certifications (1/8 are ISO9001 and 2/8 in progress to adopt ISO9001 and1/8 to adopt NFS96900). Most importantly, there is no internal resource dedicated toquality in academic laboratories. As a result, the person in charge is not dedicatedand manages quality on top of his primary function in the laboratory.As for the ELN, the awareness level is very low, taking into consideration that theacademic sector is still in the process of implementing paper laboratory notebook.For the respondents, ELN is believed to be more adapted to corporate groups.2 – SMEs: Biotechs and CRO Three contacts were interviewed: 2 CROs and 1 Biotech representing the followingpositions:- 1 CEO- 1 quality manager- 1 research engineer in charge of data managementThe interviewed contacts have the same type of data to manage as academics:- Biobank record- Sequencing data- Administrative documents and protocols- Management of stocks- Equipment booking scheduleThe three interviewed contacts are aware of ELN and LIMS and two of them use anin-house solution to manage data. Only one has implemented a commercial LIMS(Labcollector from Agilebio).Similarly to the <strong>survey</strong>ed academics, the interviewed contacts follow the samemotivation to implement solutions: strengthen internal organization, avoid waste ofbiological reagents, traceability, normalization of data, data security. The SMEsinterviewed pointed out acquiring certification faster as an additional benefit.The respondents will adopt a commercial solution if their internal solution does notwork. However the adoption of a solution is limited by the cost, lack of budget (nodedicated IT budget) and complexity to implement. Since they do not have thededicated and qualified resources, the return on investment is not worth it.It is important to note that data management solution is not a prerequisite for workingwith their clients (not a “must have” but a “nice to have”).ELN is not commonly used (0/3) because of its complexity and the respondents aresatisfied with the current paper laboratory notebook.Concerning quality, 2/3 have implemented a quality system for which 0/3 areISO9001 and 1/3 is in the process of adopting ISO9001.3 – Corporate groups Four corporate groups were <strong>survey</strong>ed to understand their expectations in terms ofdata management when working with academics and SMEs.Phone interviews were conducted with the targeted segments: 2 Pharma (Sanofi andGSK), 1 Cosmetics (confidential) and 1 Agrofood (Danone).The main reasons for outsourcing are:- Expertise unavailable in-house, lack of resources18
- Need for innovation- Design of new models- New or complementary products- Widen the offer portfolio and budget re-allocationThe corporate groups were interviewed on the type of partners for outsourcing (seeFigure 11).The ranking was the following:- SMEs (4/4)- Corporate groups (3/4) and academic laboratories (3/4)Nb. of respondents (N=4)543210Figure 11 – Typology of collaborators (NB: the respondents could give more than one answer)The criteria to select their partners are listed below:- Keep the deadline of the work plan- Confidentiality management- High quality standards for results and deliverables (no need for certification)- Social ethics compliant with the client’s expectations- Animal facilities compliantRegarding the data management system and quality status, no specific requirementsare expected. However, the partner, ideally ISO9001, GLP and/or GMP, has to offer:- High level of confidentiality- Data traceability- Structured data management (no preference over commercial or in-house, aslong as it is reliable)- Flexibility- Reactivity to meet client’s needThe interviewed contacts are well aware that LIMS/ELN are very complex toimplement and use. It should only be used if it does not lead to loss of efficiency.The paper laboratory notebook is a reliable data management solution as long as itfollows the requested quality standards.However it is important to keep in mind that standards and regulatory requirementsare evolving. Hence large companies will raise their expectations.19
Page 1 and 2: Technological <str
Page 3 and 4: ) Implemented quality standards
Page 5 and 6: Survey background 1 -‐ Backg
Page 7 and 8: Computer data management system
Page 9 and 10: The implementation of data manageme
Page 11 and 12: While the vast majority of companie
Page 13 and 14: Figure 7 - LIMS and ELN solutions13
Page 15 and 16: Usage of ELN and LIMS also depends
Page 17: - Head of platform- Head of resourc
Page 21 and 22: ) Implemented quality standards
Page 23 and 24: Nb. of respondents (N=30)3025201510
Page 25 and 26: The perceived benefits of implement
Page 27 and 28: Nb. of respondents (N=17)Surveyed r
Page 29 and 30: As indicated by the suppliers, the
Page 31 and 32: 2 -‐ Quality system The <str
Page 33 and 34: customized solutions since they are
Page 35 and 36: Appendix 1: Online surve
Page 37 and 38: □□□□Pas de besoin actuellem
Page 39 and 40: □□□□□Avantage concurrenti
Page 49 and 50: Appendix 3: Surveyed contact li
Page 51 and 52: Appendix 4: Peer recommendations
Page 53: B$: Billion DollarsCRO: Contract Re

Technological survey on LIMS and ELN in Life Sciences - Biogenouest

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