LABORATORY INFORMATICS GUIDE 2013 | DOCUMENT MANAGEMENT An example of a news feed, and a list of group members, from Mendeley


➤There is a big trend towards being able to access documents on a range of devices and from any location. It is also useful for businesses to be able to share information across multiple sites or collaborate with researchers or contract labs in another organisation. Such trends have many benefits, but there are


also concerns. The foremost of these is security. If your data or documents are held on the public cloud or on somebody else’s device how can you ensure that it is not modified or shared? And what about when a joint project ends and you no longer want to give a third party access to your documents and data? This is a problem that Spanish security


CASE STUDY


software experts Luis Angel del Valle and Juanjo Escobes set out to resolve when they founded SealPath in 2008. The first release of the company’s software, which was launched in October 2012, aims to remove this problem. ‘We saw enterprise IT departments worried


because things were moving out of their control. For example, a partner in the Netherlands was concerned that employees were using DropBox. They want to carry on, but they want it to be secure,’ says Juanjo Escobés, CTO of SealPath. SealPath is a downloadable app – currently


available on Windows, but the company is developing apps for Apple Macs, iPads and Android devices too – and documents can


UNILABS YORK BIOANALYTICAL SOLUTIONS


Unilabs York Bioanalytical Solutions provides bioanalytical, metabolism and biomarker services to pharmaceutical and biotech companies, supporting the development of small and large molecule therapeutics. Gregg Imrie is the company’s laboratory and information technology services manager:


‘The biggest problem before we had a document management system (DMS) was ensuring that everyone who was required to read documents had done so. When all records were paper, individual standard operating procedure (SOP files), at least six of them in different lab areas, and individual training records had to be checked to ensure that everything that should have been read had been. Now, a manager/QA can easily review any reading records in a matter of seconds.


‘Another significant problem


with paper was knowing where a document was in the review process – for example, I would prepare a document and pass it on to a colleague for review. It would then get left in an in-tray for weeks sometimes. It is now possible at a glance to check the status of all documents under review. Also, if I am required to review someone else’s document it automatically appears in the appropriate review page and I automatically receive an email about it. ‘We have a wide range


of document types within our environment and we use Terrington’s document management system (DMS). We already have SOPs, regulatory documents and sponsor SOPs in our DMS. These types of documents are the simplest to deal with and have a very fixed life cycle – routine review, followed by several levels of approval before release. Release of a document


24 | www.scientific-computing.com/lig2013


will automatically supersede the previous version of this document. The documents then need to appear as “required reading” for appropriate users. Once read, all records of reading are available for management/QA review. The DMS in use is ideal for these. ‘In addition, we have QA audits/


audit reports, training documents, training records and scientific reference papers, which will be migrated to our DMS. These documents may have varying levels of review and reading of these may require regular updating. ‘We also have study plans,


‘Another significant problem with paper was knowing where a document was in the review process’


who can have widely differing requirements, there are some limitations of a fixed review system. In some cases these types of documents are unsuitable for the controlled system that the DMS provides. For example, versions of unreleased documents may need to be passed outside this company as part of the review process. ‘Software


validation documentation is currently not suitable for the


study reports, file notes, analytical methods and tables of results. Some of these are maintained within our DMS; however, as we are a contract research organisation that works for a number of different clients


DMS because of the number of linked documents and the life cycle of these documents through the validation process. We (here at York, together with a sister company in Copenhagen) are currently in the process of defining a life cycle for software validations, so that Terrington can look to incorporate such complex document types within the DMS.’


be shared securely between anybody with SealPath. The document owner can set and monitor the use conditions and these accompany the document wherever it is in the cloud or on somebody else’s device. The content owner, for example, could permit a document to be accessible for the next seven days, perhaps to offer trial access for a customer or for documents to no longer be able to be opened by collaborators after a project has finished. ‘We make sure a document is safe and secure


so that it can be protected and shared on a public cloud, for example,’ adds Luis Ángel del Valle, CEO of SealPath. ‘With our technology we can make the cloud a safer place.’ Solutions that aim to address issues


like security are important for document management and will become more important as the amount of information that laboratories want to store, manage and share continues to grow. l


Siân Harris is editor of Research Information, a sister publication to Scientific Computing World that focuses on trends in scholarly publishing, research libraries and information to serve researchers www.researchinformation.info


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