laboratory informatics

to transfer and share, whether internally or with external collaborators.

Project unification Another project to promote unified laboratory operations is the Allotrope Foundation, an international association of pharmaceutical and biotech companies dedicated to the building of a ‘Laboratory Framework’ to improve efficiency in data acquisition, archiving, and management. Te Allotrope Foundation is creating

The Gran Hotel Rey Don Jaime was the setting for the latest Paperless Lab Academy

instruments in proprietary data formats. A conversion pipeline translates the data into the AnIML XML format, normalising the data into a single structure so that it can be shared and presented on different platforms. Schaefer stated: ‘True integration requires

two things – it requires communication, and it requires data being exchanged. It will only work if we have both; communication and data need each other. If we only have a communication protocol then yes we have a nice way of moving data around, but the payload is proprietary.’


The topic of data integrity was also discussed from a legal perspective, as Axon Lawyers’ Sofie van der Meulen discussed the latest developments in data protection legislation, with a particular focus on the protection of a company’s intellectual property.

Meulen discussed the new action being taken by regulators such as the FDA and the European Commission to clarify their stance on data integrity, with updated regulation on validation for labs using paperless technology. During the session, Meulen demonstrated that legislation still has some way to go, as flaws can make dealing with data protection fairly challenging. Meulen also noted that new data protection laws – the General Data Protection Regulation (GDPR), which came into effect in April 2016 – also affect informatics companies storing personal data as part of their research. l The GDPR, set out by the

European Commission, intends to strengthen and unify data protection for individuals within the European Union (EU). This new GPDR directive establisges that personal data is ‘the processing of personal data for archiving purposes in the public interest, scientific or historical research purposes or statistical research should be subject to appropriate safeguards for the rights and freedoms of the data subject to pursuant regulation.’

Meulen explained that this had

far reaching consequences for informatics industries as it would affect sensitive health data, genetic data, biometric data, and personal data. However the GDPR excludes that data ‘which does not relate to an identified or identifiable natural person or to personal data rendered anonymous in such a


manner that the data subject is not or no longer identifiable.’ With the introduction of new technology, inevitably there must also be an adjustment of the current regulation. Specifically for informatics users, as data volumes grow, as our ability to store and process this information grows,

so must regulations to protect the information contained within that data.

The overall message from this is that informatics users must be aware of the changing landscape of informatics, from both a technological and a regulatory standpoint.

JUNE/JULY 2016 27 In addition to the platform itself, a data

mapping middleware is also being made available. Tis middleware allows users to propagate experimental data to third party tools such as LIMS, ELN, databases, visualisation tools, statistics soſtware and ERP systems. Tis approach reduces the number of interfaces required to connect the different components in a paperless laboratory and facilitates interoperability. Te result is that laboratory staff do not

have to deal with proprietary file formats, making their data more accessible and easier

systems to support an intelligent, automated, and integrated analytical laboratory that allows scientists to focus on science rather than searching for, assembling, transforming, and reporting data. An important part of this integrated

laboratory is that hardware components are seamlessly shared between soſtware



Sofie van der Meulen

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