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 (SOPs) 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:
- Compliance: Provide operators with the effective version of the procedure
- Time: Significantly lessen the time it takes to deliver changed documentation
- Labour Costs: Decrease the labour cost from delivering paper documentation manually in a timely manner
- Material Costs: Decrease the materials costs associated with paper documentation and manual delivery.
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.
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 time-consuming process, because it must be repeated so many times when updating the manuals.
The process of executing a paper update was labour-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:
- each department/group received an email notification from quality that provided a list of documents that required updating
- then, the department/group prepared those documents by filling out all of the forms to notify the user of the PRCD documents, the SOP documents, and the version numbers that will change; this took approximately an hour or two to prepare the list
- next, the department/group printed out the effective version of the documents, which took another hour
- once the documents are printed, a deliverer brought them to the manufacturing floor to distribute to the correct site within an area
- when the deliverer brought the documents to an area, he verified that the document is correct according to the prepared list
- the deliverer makes more copies, the correct number for the sites in the area
- the deliverer then took five to ten minutes to put on a gown in order to enter the clean environment
- the deliverer distributed all of the documents to the correct locations within the area
- after that, the deliverer took another five to ten minutes to take off the gown
- finally, this routine was repeated two more times for the other areas.
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:
- it’s portable
- there are protective cases suitable for the manufacturing suite where it could get wet
- there are ergonomic charging stations for multiple devices
- the iPad allows for customization
- with hyperlinks, documents are easy to find, and all users link to the same location on the same server to find their documents that are controlled by BIOVIA QUMAS EDMS
- users can see diagrams better: the quality of the screen is better than photocopies; in addition, the diagrams can be enlarged for easier reading.
Restrictions were set so the user cannot download anything non-essential. Documents cannot be exported and printed because all of the other features for any installation of any applications on the iPad are turned off. The user cannot modify an account and iPad bookmarks and apps are synchronized: one iPad is configured and the others then have the same bookmarks and apps.
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.
- Although the BIOVIA application for the iPad is capable of SOP access, reviewing documents and approving documents; at this time, Biogen is focused only on SOP access. The app is called BIOVIA QUMAS Portal.
- For the BIOVIA QUMAS Portal, the customer governs the access to the site and the application, as well as access to the networks. At Biogen, the server is onsite and connection requires being on their secure network.
- BIOVIA QUMAS Portal adheres to all of the 21 CFR Part 11 and all of the general security requirements.
- The application retains a secure login. Users must still log in to retrieve documents. The documents are not stored on the iPad. The iPad is linked to the BIOVIA QUMAS Portal to view as needed.
- Documents are opened directly from the server, ensuring that the version displayed on the iPad is always the most current, effective version.
- Documents are shown in full-screen mode and display the version number. Additionally, the full screen mode feature can enable long time use.
- The application allows more than one document to be opened and viewed in separate tabs.
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 :
- how to navigate the iPad
- how to connect to Biogen’s WiFi system
- how to use the bookmark links to get to the hyperlinks for all of the documents
- how to use the search feature on the iPad to quickly find the step number in the SOP
- how to use BIOVIA QUMAS Portal on the iPad.
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
Electronic delivery of documentation has resulted in significant saving to the company.
- Saves time: manuals updated on screens eliminating the user delivering manuals to multiple sites, which was time-consuming. The saving is more than 1575 hours per year.
- There has been a labour cost saving of $110,000 per year by not having people run around to different areas to update documentation.
- Saves materials: Eliminated copying onto paper saving greater than $3300 for paper, toner and printers.
- Saves space: On tables and in the manufacturing areas because the documents do not have to be stored.
There were additional important results, although these are less quantifiable. The BIOVIA QUMAS Portal/iPad solution was also well received by the users.
- Users believe that this solution is more convenient
- Users found the solution easy to use, but familiarity with the technology was helpful
- With zoom in and out, the documentation was easier to read
- In the 2 years of its implementation, only one iPad needed to be replaced because it was submerged in water. As the iPads are covered by Apple Care, the iPad was replaced.
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.