How Thermo Fisher Boosted Compliance and Efficiency with Remote Workflows

Until last year, Thermo Fisher relied on a manual, paper-based document management strategy. As one of the largest contract development manufacturers in the heavily regulated life sciences industry, the organization dealt with a heavy influx of agreements that required printing, scanning, signing and sending to multiple approvers and reviewers. 

Even before offices were indefinitely shuttered, this outdated document management system created problems—like extended time to completion, productivity loss and a lack of visibility. But when the COVID-19 pandemic hit, the system became unmanageable. Thermo Fisher quickly recognized the need for a solution that, as technical operations manager Gord Kieth puts it, “goes beyond the electronic signature. We needed automated movement down the line, from writers to reviewers and approvers.” 

Ultimately, Thermo Fisher decided to partner with DocuSign. “In discussing a potential solution with DocuSign, there were some key features that stood out for our team,” says Kieth. Those features included: 

• Contactless routing and signing: as work-from-home orders spread across the country, Thermo Fisher’s in-office process of printing and manually passing contracts along the necessary channels was more than difficult—it was impossible. As a result, a digital, contactless workflow management solution went from cutting edge to status quo overnight. 
• Electronic envelopes: electronic document envelopes allow you to bundle and send multiple related agreements to different actors at the same time. Each envelope holds time-stamped data that bookmarks the final destination, required signatures and current location of each document—increasing process visibility and productivity. 
• Required fields: human error accounted for a significant portion of Thermo Fisher’s productivity loss. “We would often have people miss signatures, and then we would have to reroute our documents,” says Kieth. A system that requires all reviewers and approvers to complete their assigned tasks before routing a document to its next destination makes life easier for all actors. 
• Track and trace capability: One of Thermo Fisher’s biggest challenges was creating transparency in their document management process—which is critical for compliance-related internal and external audits. Track and trace capability also improved overall cycle time. “There was no longer any need to track down ‘lost’ documents,” explains Kieth. “Additionally, instead of waiting until the end of the day to manually pass documents along, the system could notify the next person in line the minute their action is required.”
• Collaborative review and approval processes: Traditionally, Thermo Fisher’s negotiation and approval process was conducted as a separate dialogue, adjacent to document workflows. “Now, we can have multiple parties to post comments, edit, and ask questions directly in the document, while tracking changes with a secure, digital audit trail,” says Kieth. 

After implementation, traditionally time-intensive processes—like creating standard operating procedures (SOPs), initiating change controls, validation, protocol reporting or reviewing and approving technical documents—were being completed in a fraction of the time (without sacrificing compliance-based needs). For instance, the average cycle time for SOP documents prior to launch was five to six weeks. Now, SOPs take an average of two weeks to complete. Cycle time for change controls was cut from five weeks to less than 10 days. 

Ultimately, DocuSign helped Thermo Fisher promote a better customer experience, more efficient workflows, and an easier validation process. “Getting this system up and running also allowed us to quickly switch to remote work,” summarizes Kieth. “75% of our envelopes are being completed in less than seven days. It used to be weeks.” Moving forward, Thermo Fisher plans on carrying their new process management solution to their other sites—and eventually wants to expand beyond GMP documents. 

At DocuSign, innovation and compliance go hand in hand 

The DocuSign Agreement Cloud for life sciences organizations helps digitally transform the way you do business, from drug and device discovery and development through clinical trials to manufacturing and commercialization. Given the importance of agreements in the life sciences business, organizations that move quickly to modernize can realize substantial benefits in increased employee productivity, better patient experiences throughout clinical trials, strengthened healthcare provider relationships, and faster time to market for new treatments.

Learn more about the DocuSign Agreement Cloud for Life Sciences or watch our webinar, Compliantly Digitize Your Global Operations and Quality Process with a Remote Workforce.