Sensible QMS Solutions

A Scalable QMS for Small Biotech

Challenge:

A biopharmaceutical company wanted to lay the foundation for several core Quality Systems.

    They wanted:

  • a quick start, beginning with simple systems that fully leveraged existing technology
  • systems tailored to the unique priorities of their particular business setting
  • strong emphasis on communicating and supporting the needs of the user community
  • systems amenable to remote access

Despite wanting to start simply, the company also wanted to start efficiently and to build early systems that would evolve gracefully as the company grew. They needed support with both system planning and set-up and also with day to day systems work.

Solution:

NovusLife was asked to provide a solution to their problem. With our extensive experience in initiating, improving and evolving Quality Systems in both small and large companies we Provided the broad perspective enabling support for big picture planning, daily work and the end user community.
The strategy specifically aimed to balance short and longer term needs. For example, maintaining records electronically rather than on paper was a priority. It is more efficient in the short term, and it also makes an immediate start on protecting company information and making it more readily available to users.
Likewise, flexible implementation is embraced. When an opportunity arises to work through a real world event with the user community, the result is not just a procedure or a technology solution – it’s a cross-functional group of people who have helped one another create a process that works, and possibly a vision of how it can work even better in future.

Result:
  • A full set of core SOPs and associated forms have been drafted, and are ready to review and issue as they become a priority.
  • Systems are being rolled out quickly as need arises (for example, if a label needs to be approved, the new label approval procedure can be finalized and used). Six months into the project, five core systems are functional.
  • Technology is supporting efficient process and remote access. New uses for existing technology are being evaluated to further improve efficiency and user friendliness.
  • Historic documents are being organized and protected.
  • The first phase of the project has been successful. The next phase will complete the remaining systems and refine all systems for continuing improvement in technology, efficiency and user satisfaction.
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