Expanding Market Access with eQMS

March 15, 2022

Following the successful deployment of EU MIA licensure and associated QP certification services by the ProPharma Group Netherlands (NL) team in 2021, our United Kingdom (UK) QPs undertook a project to be able to offer importation and batch certification for the UK market in 2022.

Knowing the pitfalls experienced by many international companies when quality activities are undertaken in silos, the UK and NL groups determined to ensure cross-company continuous improvement and leverage a common Quality Management System.

To ensure efficient cross company collaboration, the Quality Management System that supports the EU MIA held by ProPharma Group’s Netherlands office was expanded to include ProPharma Group UK. The harmonization led to an integrated and efficient Quality Management System, where over 90% of all procedures are applicable to both sites.

eQMS & Remote Working

Whilst paper-based Quality Management Systems can make for a fast deployment, they often become bogged down as an organization develops. A paper-based Quality Management System also has pitfalls, as trending and effectiveness checks are more complicated to perform, and it cannot be easily accessed remotely.

This has been brought into focus with the complexity some organizations have had to work with in order to continue operations in a compliant manner during the COVID-19 pandemic.

eQMS systems, while requiring more effort at the start of the implementation and qualification, allow for ready access to all information, and progress of data, independent of the location of the employee. It ensures a consistent approach for all sites involved, and accessibility to all information, at all times.

With ProPharma Group’s QPs being based throughout the European continent, the team decided to develop an eQMS deployment of the Dot Compliance system to be used by all MIA sites (now and in the future). DOT Compliance is a cloud-based Quality and Compliance management solution for life science companies. This system allows for the employees to be based practically anywhere, as long as they have an internet connection.

Furthermore, the system allows for distinction between the two sites, and their respective MIA licenses, allowing for sharing of data were possible, and limited access to data when required.

Efficiency

By having all ProPharma Group and client documentation available to all employees via a cloud-based eQMS, documentation review and approval is much slicker than a process which requires the relocation of physical paperwork. With the deployment of this system ProPharma Group QPs are able to work efficiently both within their teams and cross-functionally.

Compliance

By using the same eQMS across sites, ProPharma Group QPs are able to ensure that any improvement opportunities identified to processes at one site can be rolled out across the organization with ease. Continuous improvement of operations ensures that ProPharma Group sites continue to present excellent examples of compliance and efficiency. The system also allows for combined management review operations to be carried out, providing high quality input from a different perspective to each individual site.

Collaboration

Having identified partners to serve as storage and testing sites, the UK site will be applying for a MIA license in due course and plan to offer importation and QP certification as a service from the second half of 2022.

Already a MIA license holder, the NL site continues to expand their portfolio to include importation, and, in the near future, Investigational Medicinal Products.

This makes ProPharma Group the go-to partner for the launch of products in the EU and the UK, including QP support.

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