"As an FDA-compliant organisation, we need to be able to quickly find master documents from our document vault and to have version control.  DocBanq allows us to do this cost-effectively and easily."
Chris Smith CIO
 

Summary

SomnoMed Limited specialises in the development and manufacture of products for the treatment of snoring and obstructive sleep apnea (OSA).  The SomnoMed MAS is a Mandibular Advancement Splint (MAS) that treats both snoring and OSA by advancing the lower jaw forward.  It is a custom-made device consisting of upper and lower dental plates with a unique patented fin-coupling mechanism.  In addition to its patented custom-made device, the MAS, SomnoMed relies on an extensive integrated inter-disciplinary clinical team to achieve exceptional levels of patient acceptance, compliance and efficacy.

SomnoMed is based in Sydney, Australia and its products are distributed around the world.

With a limited budget and highly demanding regulatory compliance requirements, SomnoMed started to look for a solution to their information management problems.  Not only did the functionality of DocBanq meet SomnoMed's requirements, the cost effectiveness of the solution made DocBanq an obvious choice.

The Challenge

Being a medical device manufacturer, SomnoMed operates within an industry requiring the highest level of compliance in terms of document and records management.  Although conventional 'client-server' solutions have been used in the past, their prohibitive cost make them difficult for many organisations to justify.  "Not only cost is an issue but also other solutions are difficult to use and require a lot of training, and these factors really affect the uptake of the system by the users," said Chris Smith, Chief Information Officer.  Furthermore, conventional client-server solutions repeatedly fail to serve modern organisations that are geographically distributed with a highly mobile workforce.

With a distributed workforce and no central system to support collaboration between staff members, e-mail basically became the only way to share information.  Even the setup of a Virtual Private Network and FTP site didn't help as collaboration was slow, the configuration options were limited and compliance was difficult to ensure.  

The Solution

After reviewing the solutions on offer in the marketplace, SomnoMed decided that DocBanq was clearly the best solution to meet their needs.

After moving their regulatory documentation to a DocBanq account, SomnoMed proceeded with the integration of DocBanq and their corporate Intranet.  Although DocBanq is a hosted on-demand solution, DocBanq can be integrated seamlessly with existing Intranet or Internet sites in order to provide users with a complete information management solution accessed directly though the web.

The Results

Unlike organisations that opted for an expensive client-server software, SomnoMed now has a powerful document and records management solution that is not only central to SomnoMed's regulatory compliance programs but also supports the collaboration of all stakeholders regardless of their physical location.  The extremely flexible deployment capabilities of DocBanq also allowed SomnoMed to establish collaboration channels with non-employees; for example, the quality documentation set can be accessed and reviewed by SomnoMed's Regulatory Affairs Consultants with full version control, security and audit trail. 

"As an FDA-compliant organisation, we need to be able to quickly find master documents from our document vault and to have version control.  DocBanq allows us to do this cost-effectively and easily," concluded Chris Smith.

The company's plan over the next few years will be to establish manufacturing facilities in various parts of the world.  All facilities will work from controlled versions of procedures and policies which will be stored on DocBanq, while the central office will maintain the documentation and have complete evidence of its managed creation and evolution.

Web:  www.somnomed.com