Implementing Global PDF and Digital Signature Standards within Electronic Laboratory Notebooks Solutions

Pharma IQ



What Does The Future Hold For Electronic Lab Notebooks In 2012?

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In their early days Electronic Laboratory Notebooks (ELNs) were seen as an alternative to paper records, as technology has evolved further opportunities have been presented.

Collating data on ELNs allows for greater collaboration between laboratories and experiments and a more streamlined workflow. In 2008, the market for ELNs in the US was just under $1.7 billion (£1.14 billion), with an additional $70 million's worth of products and services, according to Atrium research.

The company identified that biopharmaceutical companies are leading the way in adopting ELN technology, in a bid to increase efficiency in a number of areas, such as lead optimisation, pharmacology and safety assessments.

Michael H Elliott, Chief Executive Officer of Atrium Research, explained: “Despite the global economic climate, the demand for ELN continues to be strong. Now in their fourth generation, ELN technology is expanding rapidly beyond initial installations in synthetic chemistry into biology and analytical chemistry domains. ELN has now truly become a mainstream informatics platform."

ELN use within the Industry

Pharma companies have been quick to catch on to the benefits of implementing ELNs. As there is less paperwork to do, scientists are spending extra time in the lab. The process of signing and verifying work is quicker, allowing greater compliance with international regulations. In addition, data can be more easily shared with other departments and organisations.

Novozymes, a bio innovation organisation based in Denmark, created its own ELN system to ensure minimal disruption to existing processes within the company. The company said that its decision to implement an ELN system was partly driven by its ability to offer "enhanced collaboration and document control".

Peter Wagner, Senior Manager at Novozymes, explained: "By taking our lab notebooks online, our researches now have direct access to more than 250 existing projects, in one language, across time zones, which is a tremendous benefit in terms of knowledge sharing and securing our rights to innovation."

ELNs could also provide benefits for firms which have a high turnover of personnel, or produce large amounts of visual data.

Digital signatures within ELN solutions

Novozymes is just one of the firms to implement a digital signature system within its ELN solution.

Digital signatures are becoming increasingly important for the pharmaceutical industry in terms of the verification and security of information, and can have a particular use in the field of patents. Digital Signatures allow companies to record proof of their innovation as quickly as possible, providing electronic evidence of the signature and the time and date when it was signed.

Rodd Schlerf, Life Science Market Manager at ARX, the company which developed Novozymes' system, said: "Global PDF and digital signature standards ensure that, even decades from now, the ELN documentation will be human readable, verifiable, and have legal force and effect, all important considerations for patents that extend well into the future."

SAFE-BioPharma, which is part of the 4BF group of identity trust federations encompassing the biopharma and healthcare industries in the US, has introduced a digital standard for the use of digital signatures.

In its latest survey, in June 2009, the organisation said that there are now 20 global companies, research organisations and regulatory bodies which prescribe to its digital standards.These standards are also recognised by organisations such as, the Food and Drugs Agency and European Medicines Agency, which makes them legally enforceable.

Mollie Shields-Uehlin, President and Chief Executive Officer of SAFE-BioPharma, added: “Operations become more efficient when documents are signed digitally. The need for back-up copies decreases. The cost of sending documents is eliminated, and the time and cost of document retrieval is reduced."