Case Study: One of the World’s Largest Biopharmaceutical Outsourcing Organizations “Alines” Its SOX Program by partnering with BI International
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While completing their first SOX attestation, one of the world’s largest biopharmaceutical outsourcing organizations with operations throughout 43 countries in 56 locations and approximately 6,200 employees, knew that building and maintaining a Sarbanes-Oxley compliance program presented challenges — unearthing and solving the issues that stood in the way of compliance and managing the myriad of spreadsheets and documents that are needed for the task.
In 2005, the Company completed its first year of SOX primarily by performing the tasks in shared services centers in the United States, the United Kingdom and Germany. The Company identified over 1,000 key business controls; remediate and re-tested several hundred key controls and implemented a document control process; tracked remediation; and then tested and re-tested its program.
The company passed the first year of SOX compliance, but at what cost?
Approximately 25,000 internal and external labor hours were needed, and several million dollars were invested.
The Company knew it had to find a better way. Lessons Learned and Solutions Sought
The Director of Compliance, who had been appointed to run the Company’s SOX program in year two, knew the Company had to spend significantly less time to get the work done, get the job done much faster and optimize the SOX framework. She determined that the SOX program needed to become more centrally managed.
Additionally, the Company wanted to allow their dedicated and qualified resources to better administer SOX and test internal controls on an ongoing basis. Process owners also needed to be more involved. The Company decided that the use of their internal document systems were not adequate for the needs of SOX. Therefore, they knew they needed a powerful set of tools specifically designed for SOX and configured to their needs.
Like all companies, the Company was concerned about the cost of such tools but understood this was more about reducing the overall cost of the SOX spend rather than just the software buy. They also wanted a proven solution. The risks were just too high to decide down the road that that they had chosen the wrong tool.
After studying Gartner Research’s latest reports on industry players, after listening to a multitude of recommendations, and after conducting exhaustive due diligence on a number of the key SOX tools, the Company chose AlineTM4SOX from Business Intelligence International. Although Aline4SOX had an impressive list of satisfied clients, at the time, it was not that well known. Aline™ was much more affordable than its competition, but this seemed a negative because, although it seemed to do everything that they needed the tool to do and more at the time, they worried that it would not have all the functionality down the road to deal with things they had not yet thought of. "Was Aline™ just too good to be true?"
Still, they were very impressed by the Aline's emphasis on data rather than documents, the analytic and reporting capabilities, and its simplicity to learn and use. Because Aline™ used the SaaS (Software-as-a-Service) model, the Company knew it could become fully operational in a few weeks rather than months. And with no long term commitment, the Company trusted its instincts and took a shot with the product they thought was best.
They could hedge a little, because with the speed of implementation and the low cost, they had the ability to change tactics, if problems occurred.
The Company chose 
.
The Outcome:
After one day of training and just a few weeks to get data uploaded properly, the Company's internal SOX compliance group took on Year 2 of SOX with the Aline platform as the backbone. In only months, the Company was able to reduce the
number of key controls by approximately 40 percent and was able to change a fragmented approach to create standardized controls while managing the information across all regions from a central point.
The Director of Compliance admitted: “I was at first skeptical that an affordable solution existed that could serve our needs without having to do any customization, but after getting Aline™ up quickly and with no hassle, it has allowed us to achieve significant cost reductions through both program efficiency and through key control reduction. Furthermore, the Aline™ team has been tremendous in their support throughout the implementation process as well as the support thereafter.”
For the first time, all control-related and FY06 control testing information resided in one central, easily accessible application. Click-of-the-button” reporting capabilities offered internal and external auditors, as well as the CFO, easy access to business information.
In short, Aline4SOX addressed one of the Company’s most disputed expenses — SOX compliance costs — through reduction, standardization and optimization of key controls in a simple and inexpensive manner.
Looking into the future, the Company is using Aline's compliance analytics to delve more deeply into framework optimization opportunities and are excited about the possibilities to further improve their SOX program.