Summary
What do you do? Describe your company.
Innoture designs and develops patented microneedle delivery systems for vaccines and pharmaceutical products. Innoture holds patents on the manufacture of microneedles using a unique microlithographic 3D-printing technique and is actively producing products able to deliver large biological molecules, like vaccines. The R and D department is based in Institute of Life Science, Swansea University where they have the capability for prototype production.
Challenge
What was your problem, and what challenges prevented you from easily solving the problem?
In this very much regulated industry, Innoture needed a robust QMS. Innoture worked with paper documents and was facing a real issue of space and time consumption. Furthermore, when a Quality Document needed amendment, it would take a long time to achieve due to a slow manual process.
Security was also a concern.
SharePoint was used as a repository for all the compliance documents but was not enough on its own to act as the needed QMS. BPA added the extra layer that was needed to support the QMS.
How did you find out about our solution? Did you consider other providers? What criteria did you use to select BPA and Microsoft?
Thorough research was conducted to find a product that would answer the needs. The typical pharmaceutical QMS software systems were not an ideal fit for an SME company, so when Innoture found about BPA, it seemed like the perfect choice. The ability to customize at will, the affordable price, the possibility of eSignature with Infowise was exactly ticking all the right boxes.
What was the solution? How did it address your challenges?
Innoture installed the BPA Quality template, initially just to use it for the management of the documents. The approval, version control and the different levels of access made it the corner stone of the system. But the discovery of all the other modules made the BPA choice even more pertinent: the team was pleased to find out that the processes, the risk assessment module, the audits, the NCR, the trainings could all be managed in BPA. BPA has more capabilities, than Innoture’s initial requirements and it has given us an immediate ISO 9001 capability without the need for a huge effort.
Strategy
How did you implement the solution? How long did it take? What new challenges did the implementation create?
The solution was implemented through weekly calls with a BPA Consultant. Two people here at Innoture were allocated to the system and learned the mechanism of customization. The site then went into production 6 months after the beginning of customization.
Then, as Innoture wanted to use the full array of BPA’s capabilities, a dedicated person was hired to implement and maintain new modules.
The main challenge was user adoption, but now with a thorough training programme, the system touches everybody in the company and the CEO himself uses it regularly. People are now seeing the benefit of the system and it is gaining momentum.
Results
What results did you gain from BPA Solutions – both anecdotally and measurably?
The main result is that the company is now ISO 9001 ready. Also, a number of procedures have been identified and documented thanks to the use of BPA. And of course, the treatment of compliance documents is much easier.
Was there anything spectacular about how easy it was to deploy or engage employees?
We had a very positive reception from an ISO auditor who said the system was very easy, very engaging and very useful for what we needed in term of our ISO accreditation.
Thanks to the BPA system, 100% of audits are completed and all the tasks are completed on time.
