Efficiency, control, traceability and insight

A frustration with the complexity, inefficiency, and error strewn nature of paper-based validation led the client to explore possible solutions.  What began as a commissioning and qualification validation project, has led to rolling out the solution to many more validation processes.  

Background & Challenge:

Frustrated by cumbersome, paper-based validation

The client was hampered and frustrated by cumbersome, paper-based validation. The client’s project leader succinctly described the challenge: “With storerooms full of paper, 1,000’s of protocols and 100’s of people involved, it was just too easy to make mistakes. Sharing paperwork was clunky, especially with 3rd parties. Life cycles were slowed down, efficiency was affected, resources wasted, people frustrated and the risk of getting something wrong with GDP compliance was too high”.

Need & Solution:

Partners, not just a technology provider

The client had arrived at a place where a change was required. The decision was made to first trial a digitized validation approach for their Commissioning and Qualification processes and then roll out if successful. They explored all options and subsequently three vendors were shortlisted.

Ultimately, Kneat was judged to be a superior technology in terms of features, usability and system architecture. The client was also impressed by Kneat’s knowledge and experience in the Life Sciences sector. The client’s project leader commented: “Kneat totally understood our pain, processes, needs and constraints. They were great to work with – partners, not just a technology provider.”

Implementation & Result:

Efficiency, control, traceability and insight

The Kneat team spent 7 days on-site initially to support the client’s implementation and training. We had one more short visit before going live, and the complete solution was up and running in 5 months. The client’s project leader was immediately impressed with the solution, commenting: “Kneat has exceeded our expectations. It’s an excellent solution for establishing validation processes, capturing data, executing protocols, monitoring progress and reporting. We now have the efficiency, control, traceability and insight we were missing with the old and very painful paper-based approach.” After the success of the initial implementation, the client is now rolling out the solution to more validation processes as well as other facilities.