Improve the delivery of critical documentation to employees working in a clean environment
BIOVIA QUMAS application for the iPad
Founded in 1978, Biogen is the world’s oldest independent biotechnology company. The company discovers, develops and delivers to patient’s worldwide innovative therapies for serious neurodegenerative diseases, autoimmune disorders and hematologic conditions.
Biogen’s well-known products are AVONEX®, TYSABRI®, and RITUXAN®. In 2013, Biogen launched TECFIDERA®, a new first-line oral treatment for people with relapsing forms of multiple sclerosis (MS). In 2014, Biogen reinforced their commitment to addressing unmet medical needs with the approval of two new hemophilia therapies, ALPROLIX™ and ELOCTATE™.
Although their corporate office is located in Cambridge, Massachusetts, Biogen has facilities and offices worldwide in North America, South America, Europe, and Asia.
The corporate headquarters located in Cambridge, Massachusetts, includes a small scale manufacturing facility and serves as a test bed for new technologies in improving operational efficiencies.
Since 2002, Biogen has used an Electronic Document Management System called BIOVIA QUMAS EDMS to manage procedures, master records, forms, technical reports, risk assessments, and other department-controlled documents.
This case study focuses on how Biogen improved the delivery of critical documentation by leveraging BIOVIA Quality and Regulatory Compliance Management Software on Apple iPads.
THE BIOGEN CHALLENGE – IMPROVE “DELIVERY” OF CRUCIAL DOCUMENTATION
Inherent in a biotechnological and pharmaceutical manufacturing facility is a constant cycle of change, as well as the need for utmost control over the changes. Because the Standard Operating Procedures (SOP) are so crucial to the success of a product, there must be strict controls around the recording, storage, and communication of any modifications in the manufacturing facility.
Biogen’s Cambridge Manufacturing Facility leaders assessed their paper-based SOP delivery system. Their findings were that their procedures were inefficient and costly. As a result, they established the following four goals for improving the process:
Their solution to the inadequacies caused by the paper documentation was to move the access to the documentation and the method for delivering it to an electronic device.
— Gregory Chua, Senior Manufacturing Support Associate
THE SCOPE OF THE BIOGEN CHALLENGE
In the Cambridge manufacturing facility, there are three Good Manufacturing Practices (GMP) areas. Each area has its own procedures and forms that are subject to updates. The Cell Culture area has 233 procedures and 68 forms. The Dispensary area owns 179 procedures and 112 forms, and the Purification area has 252 procedures and 65 forms.
Updates must be delivered to many sites. Within each area there are a number of sites that must receive updates. The Cell Culture area has 18 sites, Dispensary has 13, and Purification has nine. This means that every time there is an update, the deliverer must visit 40 sites.
Also, the manufacturing floor is a clean environment. As a clean environment, a person, such as the deliverer of the paper updates, must put on a gown when entering the areas and must remove the gown when coming out. It is a timeconsuming process, because it must be repeated so many times when updating the manuals.
The process of executing a paper update was labor-intensive and time-consuming. It took about six people to perform an update - one person to prepare the update and one to verify that the update was done correctly, and four different deliverers to perform and verify that the updated documents were placed at the correct site.
The old update process was the following:
At Biogen, frequently there are unscheduled updates throughout the week. Whenever there was an update, the process was repeated.
THE BIOGEN SOLUTION: A DECISION TO MAKE DOCUMENT UPDATING ELECTRONIC
The Biogen Manufacturing team in Cambridge decided that the solution to the inefficient updating of paper documentation was to use an electronic device for viewing documents and to view the documents via a BIOVIA application.
After a comparison of devices, Biogen in Cambridge selected the Apple iPad for its delivery vehicle. Certain iPad features stood out:
THE BIOVIA CONTRIBUTION
After selecting the iPad, Biogen relied on their compliance and quality management partner, BIOVIA, to provide the interface that would allow them to make their documentation available on the iPad in a way that is faster and less costly.
IMPLEMENTATION OF THE SOLUTION
Biogen implemented the solution over a year. Job aids were given to all of the employees involved. They created iPad ambassadors on the manufacturing floor to provide assistance and support to employees. In addition, employees received the following training:
Very importantly, a manual index with hyperlinks was created for each department. Via the index, users can go through the list of documents chronologically to find the document they need and open them without worrying about searching for them.
BIOGEN MEETS ITS GOALS WITH IMPRESSIVE RESULTS FROM THE BIOVIA/IPAD SOLUTION
Electronic delivery of documentation has resulted in significant saving to the company.
There were additional important results, although these are less quantifiable. The BIOVIA QUMAS Portal/iPad solution was also well received by the users.
Based on the results that were achieved at the site in Cambridge, Massachusetts, Biogen is making plans to roll out the BIOVIA / iPad solution to its other manufacturing sites around the globe.
BIOVIA from Dassault Systèmes provides a scientific collaborative environment for advanced biological, chemical and materials experiences. The sophisticated enterprise system of modeling, simulation, laboratory, and quality management enables innovation for science-based industries. For Regulatory, Quality, and Compliance Management, BIOVIA QUMAS provides an integrated solution for all quality process and content activities from lab to commercialization, maintaining regulatory compliance with global mandates.
Dassault Systèmes, the 3DEXPERIENCE Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported. Dassault Systèmes’ collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world. The group brings value to over 190,000 customers of all sizes, in all industries, in more than 140 countries.