LABORATORY INFORMATICS GUIDE 2013 | END USER VIEWS


David Butler, director of quality at Quotient Bioresearch


O


ur analytical laboratory in Cambridgeshire handles in the region of 15,000 samples per month and my


task is to ensure that we work to the regulatory requirements that cover the development of new medicines. We need to run efficiently and effectively, and deliver a good service to our customers. To facilitate this, we have several large informatics systems. All our data is collected from our instrumentation and fed into a Thermo Fisher Watson LIMS and we are in the processes of validating and deploying a PerkinElmer ELN. Our specific document management needs are met by software called X-docs, from GXPi, which controls everything from our R&D documentation to our procedures and policies. Implementing these new systems took longer


than we expected – which always seems to be the case. The biggest problem we had with X-docs was that we were migrating from a previous electronic system and the format of


previous electronic system still necessitated the printing of paper record’


‘The system really has had a positive impact as our


all our documents and records was completely different. There was a file transfer, but we had to spend a lot of time cleaning everything up as the data didn’t go across smoothly. Checking all the documents was quite painful, but the rollout of the training and getting everyone used to the new system went well. Because the new system is built on SharePoint it has a familiar Microsoft-feel to it, which meant that people picked it up very quickly. The validation took time, but it was otherwise straightforward.


The system really has had a positive impact,


as our previous system still necessitated the printing of paper records. Now, people print documents because they want to, rather than have to. The fact that we no longer have to chase researchers for signatures or archive records in numerous boxes has also saved time. The customisation of the system has also resolved a few of the issues we were having. For example, with the previous software if a


Martin Johansson, senior director, business informatics, at The Medicines Company


D


uring a recent clinical trial, we outsourced the clinical operations piece, the management of the TMF


(trial master file), and the monitoring process to a contract research organisation (CRO), and what ended up happening, as often does, is that we received a large number of CDs and big boxes filled with documents which then had to be processsed. We then had to assess whether we did in fact have everything we needed. As you can imagine, this is incredibly time consuming and so we began to incorporate these steps into the workflow process that had been set up for our internal team. Each team can now utilise SharePoint and we structured a TMF and utilised content tags to ensure documents are consistent, while an automatic process means that files and all the associated metadata are subject to naming conventions. We have then invited the CROs we work


with to use the systems and tools that we have put in place, so that we no longer have to rely


28 | www.scientific-computing.com/lig2013


on being emailed or sent files. Instead, they simply save the data in designated areas of the TMF where it can be reviewed and accepted by a member of our team, or rejected with comments sent directly back to the CRO. This has helped ensure we have all the requisite documents and helped CROs, as many don’t have systems or tools in place that go beyond network drives and folder structures for documents. We have found that they are appreciative of the fact that we have a process in place that can simply be extended to them – SharePoint makes this very easy to do. In the past we have considered


implementing a LIMS, but decided that we first needed to take a step back and address our initial needs with the view of building out from there. We assessed our biggest pain points and identified our exposure from operational and compliance perspectives, and


‘One of our main concerns was that the solution had to support our business goals, clinical trials and R&D efforts’


while there are systems that have far more specialised capabilities than SharePoint, we felt it was the best foundation for us. One of our main concerns was that the solution had to support our business goals, clinical trials and R&D efforts. We haven’t gone beyond SharePoint, because not only does it fit in well with the resources we have, but our end users are already familiar with it. SharePoint is not without


its problems. The mistake many people make is that they treat it as just another file sharing system. But, if you hone in on what you


are trying to accomplish and what specific business problems and processes you are trying to address, and then form a structure around it, you stand a much better chance of having something that goes beyond being yet another place to save a document. If you don’t focus on how the systems can help end users, you’ve lost the battle before it’s even begun. l


document was ready there was no way to circulate it before it was issued. This meant that if it was released on a Tuesday morning, it had to be used Tuesday morning with no warning. With the new software, we can now circulate the document beforehand; we have it set to seven days prior, but it can be customised to any number. This has also improved our situation with the regulators as it ensures people have sufficient time to thoroughly read the documents before implementing them. Gaining the confidence of the regulators, and


our own customers, has been a challenge. There seems to be a strange paranoia surrounding anything electronic and as soon as the question of changing systems is raised people seem to panic about what will happen should the data get deleted or the server crash. My experience has been that electronic systems are far more robust and safer than paper alternatives – if the paper archive burns down it’s gone for good; if the server burns down we have back-up tapes.


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