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Proving Efficiencies by Going Paperless


Submitted By mabarber11
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Proving efficiencies by going Paperless

In an effort to reduce the amount of paper my team was generating for my Company, I needed to prove the efficiency of obtaining an electronic system to create and store documentation. A company trying to go paperless can be a vast undertaking as well as very costly. Since cost will drive the change, I needed identify the key components and benefit it would be to the organization to obtain such a tool. It would seem like a simple change, but when you work in a regulated environment, you need to ensure you have the right system in place that does not compromise data. There is also always that question of how do you make that switch, what is the best application to use to drive cost down, and more importantly, what do you do with all the existing paper?
During my tenure with my company, I was a manager of a validation team that tested Interactive Voice Response Systems for Clinical Trials. Paper documents were printed daily, showing proof of work performed, and kept in a locked storage cabinet for future use. Over time, and many discussions with my staff and outside clients, it was apparent that our competitors were way ahead of us technically and were moving in the direction of using paperless systems. The collection of paper that my teamed generated was in massive quantities. The storage of the documentation became a greater problem since space was limited. The issue was that documentation, needed to be kept for the lifecycle of a study just in case there were any patient safety issues, since the Regulatory Authorities may ask to review the documents so they would be easily accessible. I not only had to convince the goverance approval team but the Regulatory Compliance team as well to approve an application that would satisfy the regulations of an electronic system.
I started this initiative by researching companies that could potentially be a good fit for the needs of my team and the company. As part of the research, I needed to ensure that the vendor I chose for my proposal housed a software application that would allow for documentation with electronic signature capabilities, and documents that could be stored in a repository for later use as proof of evidence that are computer systems operated appropriately. After much deliberation, I narrowed it down to two (2) vendors. The first vendor came to my office and provided a demonstration of their system. The features, however did not fit the needs of the organization and overall would be too costly. When it was time for the second vendor, I decided that it would be beneficial to visit their facility and receive a demonstration on-site. The meeting was successful. A plan was determined for their team to visit my company to ensure that their system was compatible, and there would be no issues with implementation. The visit went better than expected, and requirements were discussed on the needs to make the paperless process begin. The last step was to receive a cost so I could input this into my proposal and submit for approval.
Once all information was received from the vendor, and all my notes recorded, I was able to start on the writing of the proposal. The plan would include the purpose and use of the tool in order to get this initiative approved; a system that would be used as a respository for electronically stored documentation. Electronic signatures ws also a plus since wet signatures were no longer needed and could save time of waiting for someone to sign a document if personnel was off-site working. An important note to include was to describe how it will drive cost down by eliminating paper, it will allow for efficient time used by the staff. The cost as well was within budget limits and demonstrated that over time the cost of the tool will pay off taking into consideration what is incurred yearly on paper, supplies, storage space, filing, etc. The current documentation that required storage could also be scanned and uploaded into a repository for later use which would eliminate the need for more filing space. After close review and discussions with the vendor to ensure the data received was accurate, I submitted the proposal for approval.
As I waited several months for feedback, I knew from the beginning of this process that there may be the potential that it will not get approved due to the overall expenditure to the company. Sure enough, after months of waiting the decision was made not to move forward with acquiring the value of the tool. Even thought it was in budget it was a cost and undertaking they did not want to incur. Although my goal and process improvement initiative to go paperless was achieved, it was quite disappointing that it did not get approved.

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