bioMerieux, a global in vitro diagnostics company, has found answers to many of its collaboration and document management challenges using Open Text’s Livelink platform.
bioMerieux, a global in vitro diagnostics company, has found answers to many of its collaboration and document management challenges using Open Text's Livelink platform. According to Ted Walsh, Senior Project Manager, MIS, bioMerieux, the company is relying on Livelink as its global solution for electronic document management.
The system, originally in place at Organon Technika before the company's purchase by bioMerieux two years ago, was selected as the EDMS platform for the newly merged organization. bioMerieux saw the technology and liked it and we'sve been picking up on it ever since, Walsh said. It has been chosen as the corporate platform for EDMS.
It is the system that will carry and harmonize information (content) throughout bioMerieux's subsidiaries and manufacturing sites, Walsh said. It's the old adage of getting the right information to the right people at the right time.
Walsh admits even with the right software platform, it's a tall order. It's a difficult task to organize and prioritize and implement in a very methodical approach that doesn'st lose its steam, he said. But the payoff is tremendous once you'sre able to harmonize the information.
According to Walsh, bioMerieux is in the midst of a data migration to make all of the company's CE Marked information for all subsidiaries accessible through Livelink.
For instance, in Poland our subsidiary needs to provide the Polish language on the package inserts, labeling and other product documentation, he explained. So, Livelink allows us to store that information in a publication area that can be accessed by the subsidiary in a PDF format. They can service themselves by pulling the artwork for labeling, for instance, and know it's the actual production piece of material they need. No correspondence between the manufacturing site and subsidiary need take place.
Walsh finds this brings consistency and conformity to the process. Which is obviously what the FDA likes to see, he said.
We are slowly moving to a paperless environment, Walsh added. We started with publications just to find a methodology to start migrating documentation into place. Once it's in place, it actually goes through a change management system, which ultimately will happen through an application developed on Livelink for the open applications. Then we'sll add e-signatures and go completely paperless. The entire document lifecycle is regulated from creation and editing to approval, publication and record management.
According to Walsh, the company's design history files have been added to the system for the past three years. Once they become regulated documents, they are placed into Livelink as a scanned Adobe Acrobat PDF document with the signatures assigned, he explained. But we also surround the documentation with metadata in the form of attributes to make searching easier and that's been a really big plus and DHF is a validated system.
And using Livelink with Acrobat documents recently became easier with the launch of Livelink Review Manager for Acrobat, that lets users securely execute multiple, parallel reviews of legal and regulatory documents. Review Manager integrates the review and comment features of Acrobat with Livelink's document management features, allowing a team of annotators's comments to be tracked and collated with ease.
Most importantly, from a pharma perspective, all of this is being audited and protected with the powerful security features of Livelink, added Martin Sumner-Smith, Vice President of Pharmaceutical Solutions at Open Text. It's a really nice tool that doesn'st require any extra plug-ins. If you have the full-featured version of Acrobat, you have what you need to annotate documents in Livelink.
bioMerieux also uses Livelink in its clinical trials. Walsh and his colleagues recently built 23 trial forms for use at three hospitals for a problematic clinical trial. The trial initially started with a form that was unstructured and the data was double entered to prevent key stroke errors, Walsh said. This was time consuming, and the alternative to take it out of house was expensive. With the Livelink platform, we were able to first, provide a more structured form and second, provide an improved method for data capture with Teleforms, a fully integrated scanning and imaging module from Open Text partner Cardiff.
The investigators now send the recorded information to our clinical affairs group, where they scan the information and validate the scanned data, he added. Then, the data is automatically sent to a database and the scanned image is placed into Livelink with attributes surrounding it. They went from a process where they were double-entering data from screens which took about 45 minutes, down to about 10 minutes per patient now.
Teleforms, Walsh said, streamlines data verification. Teleforms will stop you on particular fields and flag potential errors, he said. Instead of having to drop back and resubmit to the hospital for their signature, they basically just resubmit and verify the change. The ability to make some changes on the fly makes the data within the database more consistent. The data is much, much cleaner and consistent. The data capture works very well, and there's a lot you can do with it.
By next year, Walsh anticipates bioMerieux will eliminate the need to scan documents. That's been the vision for the last three years, he said. It was just a matter of getting the funding and licensing in place, which we have now. So, it's just a matter of time.
Open Text's solutions are a good fit out-of-the-box. The interface is fairly simple. It's Web-based which makes it easy, and we'sve made very few changes. Actually, we have no customizations at this time.
Walsh praises Livelink's audit capabilities. Workflow Manager allows you to set milestones and dates and will alert you and allow you to send e-mail notification regarding documents that require action, he said. In addition, you can build all kinds of reports using Live Reports. We use that all of the time to provide reports on the different applications we have on there.
Consistency and conformance that's what the workflows bring to the environment and that's where your big payoff is publications are fine, but if you'sre struggling to get them into the system accurately, it's not really worth much to you. So, the payoff for us will be to go completely electronic working closely with Quality Assurance and Regulatory Affairs to make sure we'sre doing things correctly. And we'sve done an audit on Open Text and feel comfortable it can reach CRF21 Part 11 compliance.
The other positive aspect of working with Open Text, according to Walsh, is how the company's structure enables its customers to network with similar companies facing common challenges. Because Open Text is now organized vertically with a Pharma and Life Sciences division, it has a tremendous impact on our ability to network. To be able to call somebody and have them say: Oh, yeah, Pfizer's doing that, let me talk to them.'s I'sve been able to talk with people at Pfizer and J&J and some of the other companies using Livelink and that's good. We'sre mid-market and don'st always have the resources others have. Being able to interface with them is a tremendous help.
It's a great mid-market solution and if you look at how Pfizer's using it, you could make a very strong case that it's a very solid platform.'s We certainly don'st call it an application,'s it's a lot more than that and big companies are taking it that way, too.
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