Digitizing the entire validation life cycle: A productivity leap

The client, a US headquartered tier one biotech with multiple facilities in the US and the EU, achieved productivity improvements of 100% after digitizing validation on the Kneat platform.

Background & Challenge

Rapid growth requiring increased productivity 

The client introduces many new therapies every year, and with the addition of a new facility, the number of paper-based validation protocols required was forecast to grow rapidly from an already high average of 700 per year.  Increasing regulatory expectations were also contributing to the validation challenge. 

Need & Solution:

Validation enhancements across all facilities

The client needed to implement a digitized validation solution that would deliver productivity gains and support ongoing growth.   

To achieve this, the client sought to eliminate paper with a single platform, capable of managing and executing all records across the entire validation life cycle, automation of record storage, search & retrieval, real time visibility of all processes at site and global levels for managerial purposes, and robust data integrity.    

Implementation & Result:

A productivity leap of over 100%

Following an assessment process, the Kneat platform was selected. Kneat’s capability to remove paper from all stages of the validation lifecycle was cited as the deciding factor to implement, and the key to achieving their productivity goal.

“By going fully electronic, we reduced the number of manual and paper-based Validation process steps by 60% and the results are impressive; productivity improvements of more than 100%, cycle time reductions of more than 60%, cross site alignment, Validation quality and Compliance assurance improvements. Kneat eliminates frustrating clerical type paper-based activities and allows staff to apply their skills. It removes the chain that is the paper system”, Company QA Engineer.

Facilities, utilities and equipment validation protocol processing times were reduced by 50%, to an average of just 20 hours.  This enabled the validation team to take on additional activities, enabling greater output.  

Specific improvements observed by the client

• 85% resource and cycle time improvement for changeover processes
• 60% reduction in test protocol cycle time
• 48% reduction in pre-execution approval time
• 58% reduction in post-execution approval time