Biogen Idec




Square ft.


cGMP Compliance Inspections

As a drug manufacturing company, there are numerous federal regulations Biogen Idec must adhere to known as “Current Good Manufacturing Practices” or cGMPs. The government published Code of Federal Regulations (CFR) calls for frequent cGMP compliance inspections of labs throughout the biotech/pharmaceutical industry. Biogen Idec has over 150 labs totaling approximately 250,000 square feet in its Cambridge, Massachusetts, operating facility that fall under these regulations.

Searching for solutions

While Dayone Solutions Software is typically for construction inspections, Biogen Idec found a unique way to use Dayone Solutions Software. In the highly regulated pharmaceutical industry, it is critical that all of Biogen Idec’s labs are in perfect condition for federal inspectors during cGMP compliance inspections. Biogen Idec began searching for a solution to keep their labs in “inspection ready”condition. The goal was to find a better way to do their own inspections and to track and correct any deficiencies prior to the cGMP inspections.

After a thorough search they chose Dayone Solutions Software and began using it at their labs. We asked Thomas Choyce, Senior Engineer II, Facilities Department what Biogen Idec did for their inspections prior to Dayone Solutions Software. “It was a highly manual task involving creating lists of architectural deficiencies as you walked through and inspected the areas. The walkthroughs required a lot of personnel time to complete. It wasn’t the most efficient process, and we were really looking for a way to streamline the punch listing efforts by our various groups.” Choyce then elaborated on some of the unique aspects of lab inspections challenges that Dayone Solutions Software to helped them overcome.

Easier and more efficient

Choyce said, “Tracking specific issues and relaying them to the folks that resolve them. Dayone Solutions Software enables us to snap a photo, upload it into the punch listed item, and show it as a mark on a drawing of the area. The painter can take the report and locate what we are talking about easily by looking at the photo. Dayone Solutions Software makes our jobs easier and more efficient. This is especially true since going into clean areas requires the person to get gowned up, and coordinate whatever activities might be going on in the room.”

Dayone Solutions Software enables us to snap a photo, upload it into the punch listed item, and show it as a mark on a drawing of the area.”

Choyce went on to say why Biogen Idec chose Dayone Solutions Software over its competitors. “We reviewed the capabilities, cost (both initial and maintenance), setup/configuration, and ease of use of several products we found. Dayone Solutions Software had all the features we wanted at a reasonable cost. The biggest reason however, was the ease of use and reporting features. Having segregated areas, specific reports, and pictures was seen as the solution to many problems we had tracking repairs the old way.”

Major improvements

Choyce said that Dayone Solutions Software was a significant improvement over their previous methods because: “We now have a central location for any pictures of facility issues. I like to take a picture of the issue, say chipped paint, and then when it’s repaired, we retake the picture of the finished area, attach both to the punch listed item in Dayone Solutions Software and mark the issue as complete. This gives us a good before and after record of what we did. We can show how much we’ve accomplished over time by querying the completed items. We can see what types of things come up more often than others. This is very helpful when forecasting facility budget needs. We can keep track of things easier and more efficiently now. Now it’s in there as an open item until it’s completed and marked accordingly in Dayone Solutions Software. Being Web-based makes it convenient for several people to utilize the software. We set up a few user groups who are now able to log onto their iPads and walk around the plant, adding items as they see fit.”

“We’re able to significantly reduce the number of trips we make into the plant each week resulting in an annual savings of $10,000 or more.”

Significant ROL

Biogen Idec experienced a significant return on their Dayone Solutions Software investment. “We’re able to significantly reduce the number of trips we make into the plant each week resulting in an annual savings of $10,000 or more. In addition, because Dayone Solutions Software makes the job of inspecting so much easier, the GMP areas now look better than ever.”

As a result of the switch to Dayone Solutions Software, the Global Engineering and Facilities group where Choyce works received Biogen Idec’s prestigious Innovation Award. The award was based on: Providing opportunities to objectively demonstrate the value of new technologies and/or approaches, demonstrating whether or not a new technology approach has a viable business justification in the biotech/pharmaceutical environment and studying an improvement opportunity topic in greater detail than existing resources/timelines would normally allow.

Biogen Idec, the world’s oldest independent biotechnology company develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. A Fortune 500 company, Biogen Idec has one of the leading capacities for biologics manufacturing in the biotechnology industry.
Cambridge, Massachusetts
Biotech / Pharmaceutical Industry

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