Biogen's Lab of the Future

Biogen Inc.
Analytical Instrument Validation

The client, Biogen Inc., contracted Kneat to deliver their vision for the future of laboratory operations. Biogen Inc. (previously known as Biogen Idec) is an American multinational biotechnology company specializing in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases.


Background & Challenge:

A vision for the future

Since 2014, Biogen has used Kneat across all sites to manage facilities, utilities and equipment validation, cleaning monitoring, production equipment changeovers and integrated commissioning and qualification (for more read, Digitizing the entire validation life-cycle).

While Biogen already relied on advanced equipment and computer-based analytical systems, many of the laboratory record-keeping, processes remained manual and paper-based. The QC leadership recognized that migrating to a well-defined electronic record-keeping process offered the potential to significantly improve cycle time.

In 2015, Biogen’s QC leadership developed a vision for the future of its laboratory operations & laboratory life-cycle management process, a ‘QC Lab of the Future’ and began working with Kneat to deliver it.


Need & Solution:

Digitizing the laboratory asset management process

A cross-site team established by Biogen’s QC leaders defined the desired project outcomes and requirements for the ‘Lab of the Future’ vision including:

• Converting analytical instrument validation (AIV) process from the paper-based to fully electronic, complete with integrated test execution and reporting;
• Eliminating non-value-added process activities such as manual review and approval, redundant validation documents, redundant review and approvals, paper-based test execution, records archival and status reporting;
• Harmonizing the asset life-cycle management process across sites;
• Harmonizing the lab equipment selection process across sites;
• Reducing ‘on-boarding’ cycle time of new assets, from order to release from use;
• Centralizing management of laboratory asset records for quick access and retrieval;
• Establishing an easy-to-use, real-time register of all global lab assets;
• Enabling real-time visibility of validation, periodic review status and other records by management for all global assets;
• Minimizing potential data integrity issues;
• Minimizing downtime for laboratory assets related to asset life-cycle management activities;
• Improving laboratory asset change control and change impact management;

The cross-site team then compared the Kneat system, already in use for other applications, against the defined key requirements and concluded that Kneat could support all of the goals of the project.



Implementation & Result:

A simplified, harmonized laboratory asset life-cycle

Before recreating them electronically in Kneat, Biogen worked closely with Kneat to first optimize their existing paper-based AIV processes. This involved streamlining workflows, removing excessive content, process requirements and redundant approvals.

Following the overhaul of AIV processes, a pilot deployment of the new digitized AIV system process was then implemented in February 2017.  Taking just two months to implement, the pilot was approved by Biogen for a full release in just six weeks.  Within only three months of operation of release, Biogen had reported productivity improvements to laboratory asset life-cycle management of over 100%.

The average number of lab validation documents processed between 2014 and 2016 was 160 per year; the number of validation documents processed using the new system reached 170 within its first three months.


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