Collaboration is an integral component in today’s pharmaceutical product life cycle. In the past, most activities were managed in a fairly localized way. Colleagues worked in the same building, meeting in person to discuss and exchange ideas. In today’s world, the traditional four walls of the office have been broken down and teams now extend around globe and beyond the corporate firewall. The industry has had to learn to interact and collaborate in non-traditional ways.
By Jason Halpern (Follow @jasonhalpern)
Undoubtedly these interactions are to the benefit of the company, by providing new insights and access to subject matter experts, and allowing for certain operational efficiencies. But it has not come without new challenges and concerns.
How do you share this information in a flexible and adaptable way while retaining control over and security of your documents?
One approach to addressing this issue has been for pharmaceutical companies to assert firm control over the document management process. They need assurance that their intellectual property is secure and that partners are only able to see what the company wants them to see. Simply sharing files across platforms through an FTP site or an open cloud doesn’t provide the security that is so critical for the industry.
Enabling a process by which documents can be created, managed and maintained in a secure manner is only the first step. How do you ensure that everyone follows the expected procedures and understands what they need to do? Providing training to the end user is often considered the first step, but it really should be the last one. While it’s critical for users to know how to adhere to a process or to use a tool, it’s even more important for the process to be designed in a way that intuitively makes sense for the end users and for the system to be simple. Companies need to enable usability.
By implementing a process that makes sense and utilizing a tool which requires minimal training, users and their employers can feel more comfortable more quickly. When users feel comfortable with a tool they are less likely to try to work around a process and more likely to follow the expected protocols. This helps to ensure a more complete audit trail.
The process becomes even more important when involving external participants in document collaboration. External users often do not have the benefit of the same level of training, resources or support as their internal counterparts. They may not have an account in the corporate domain which can often lead to workarounds or accommodations in order to grant them access to information or to work with the team. As a result, employees often forgo involving external participants when it’s not essential, in order to reduce the hassle. If this happens, the company can lose out on potentially valuable insights and expertise. Other times employees choose to work around standard processes, thus potentially jeopardizing the audit trail or putting intellectual property at risk.
An intuitive system that works in much the same way as any widely used website removes those hurdles by encouraging users to use the tool and comply with the expected processes. If using the tool facilitates easy collaboration, it doesn’t take much work to convince everyone to follow the process.
The goal for any company is to ensure that the best information is available to the proper audience so that they can make appropriate decisions for the firm. In order to achieve this goal, they need to implement a process that encourages the use of best possible resources. By removing barriers to working together and allowing users of all types (super/casual, internal/external) to feel comfortable with the process, they can ensure the best available information is used in electronic submissions. All of this allows companies to achieve higher quality and more reliable outcomes – and that’s an outcome that we can all live with.