Life Sciences Company Achieves a Brilliant Vision with Intelligent Document Processing and Content Management

Besides working with dated technology, the Company faced multiple challenges. A major hurdle was meeting FDA regulations and compliance measures. Throughout the organization, many departments and business units had antiquated, manual processes, which made it even harder to comply. For example, the Research & Development department had to manually insert page separators in between documents, which was time-consuming. Another manual process for the customer service department was manually archiving intraocular lens (IOL) implant cards from surgeons to meet FDA rules. 

In the manufacturing department, they were archiving around the clock to meet compliance requirements. With thousands of surgeries daily across the United States, the team had more work than they could keep up, so they were consistently behind in processing and archiving. Additionally, managing the entire life cycle of their R&D content from creation to end-of-life as defined by a retention policy was critical. However, the hardest part was going to be change management, as the old ways were ingrained into their daily life.

After evaluating options and several product demonstrations, fme US recommended the combined solution of using Ephesoft Transact for intelligent document processing and capture with Alfresco’s content services solution as their iPaaS in their US offices. Ephesoft Transact would capture, classify, extract, validate and export data into Alfresco’s Content Services application. “Capability and functionality was our deciding factor in selecting Ephsoft and Alfresco,” said the domain architect. 

fme US decided to use Ephesoft’s Professional Services (PS) team for implementation of the project in two phases. After a discovery analysis, the team began moving forward in three main areas: Research & Development (R&D), Manufacturing & Technical Operations and Commercial (Customer Service). 

Use Case: R&D 

R&D documents consisted of clinical data, documentation, regulatory documents and other types, which all had to be archived. They were processing about 500 to 600 documents per day, but most of these documents were multiple pages averaging around 20 pages each. The total estimate was 10,000 to 12,000 pages daily. The complexity and volume of R&D documents require about 3 to 4 users to process their documents.

Use Case: Manufacturing & Technical Operations 

Manufacturing & Technical Operations were processing about 100 to 200 packages per day, which were standard operating procedures. These packages usually consisted of more than 1,000 pages per package, making the daily total process for scanning, capturing and extraction about 100,000 to 200,000 per day. The packages required archiving to meet FDA regulations. With Ephesoft in place, the Company only needs 1 or 2 people using the system for this team depending on the number of packages.

Use Case: Commercial

Under the Commercial (Customer Service) department, the document processing was operating at a high volume. Before COVID-19, there were between 10,000 to 12,000 eye surgeries happening each day all over the United States, with some days as high as 15,000 surgeries. An implant card created by the surgeon was needed for each patient, which was only one page in length. During the pandemic, the eye surgeries dropped to between 7,000 to 10,000 per day because usually, it was an elective procedure. Before using Ephesoft Transact, processing this volume was difficult, but now, they typically run 40,000 to 50,000 batch loads of documents efficiently. This team also only needs 2 to 3 people to manage the solution depending on the document volume.

Phase 1 went live during the COVID-19 pandemic in August 2020. To meet the high volume demand of their documents, the Company first installed two Ephesoft Transact 8 cores (servers) to manage the batch sizes, but upgraded to two 16 cores with one 8 core UI server, which manages the number of concurrent users and web scanners, after widening their project scope. They also implemented Ephesoft’s Advanced Reporting tool. In total, the PS team customized 8 batch classes for each of the business units, containing about 150 document types that pulled 8 standard fields of data for the different use cases. 

“The learning curve was high in the beginning because the staff was not used to using modern technology. Now, the team is highly capable, productive and can manage their workload with Ephesoft,” explained the project leader. “The Professional Services team helped us a lot! We asked for a lot of changes along the way and wanted the work done faster than was originally planned. They came through for us and delivered a great solution.”

The domain architect and project leader described that the time savings of using the Ephesoft solution is huge and requires less people. The mere time savings of no longer having to put sheet separators is incredible. “The system is smart enough, very intuitive, easy to maneuver and validate.” He did have some advice to share to other future customers: “Understand your requirements before you start the project. Ours kept on changing, which increased the project timeframe. We won’t do that again! However, make sure you keep an open mind to change. We have to continue learning and growing with technology.”

The Company’s team was pleased with the results. “We organized ourselves to go live earlier than anticipated and were very successful. It was a big win for us.” The best features were Ephesoft’s auto-extraction and classification. The bonus for the Company was that the Alfresco integration was already in place, which made the deployment even easier. 

After the next phase is completed, they are considering expanding the solutions globally, with their eyes set on Malaysia.