Quality & Compliance
Safety & Vigilance
04 august 2022
The lifecycle of a medicinal product or medical device has always been intensely data-driven. The collection and safe storage of this data are one of the most crucial elements in the maintenance of the product on the market.
There have been significant strides in how data is stored. Physical files to digitised data stored on hard drives to now those same files being stored on the cloud. Secured cloud storage has the advantage of cross-communicating with software via an Application Programming Interface (API). This integration leads us into a renaissance period of data and document management.
With all the technology available, you’re still required to navigate such; doing so requires some specialised expertise. PLG was approached by one of our long-term partners (>10 years of service), to transition into a Regulatory Information Management (RIM) Suite to become compliant with Identification of Medicinal Product (IDMP) regulations.
PLG assessed the challenges being faced by the client and categorised them under three main topics.
Design: With such a company-wide project, it was important for the client to identify the key stakeholders of the data. The client would also have to envision a permission strategy for each of these stakeholders. These would all have to be done in the context of the regulations governing IDMP/SPOR.
Migration: The actual migration of the data was a main concern for the client. All data within the company had to form a global comprehensive end-to-end suite. Enhancing the operational use of the data by the integration of new functionalities within the suite.
Training: Linked to the design challenges of understanding each stakeholder’s interaction with the data, the client had to prepare clear training materials for each “User Perspective”.
ProductLife Group, with our multifaceted in-house experts and 29 years of experience in the regulatory landscape initially proposed a plan to the client. A systematic approach on how to migrate the existing data to prevent losses, minimise company downtime and maximise efficiency.
We initially started with a Change Management plan. This would have included a look at the current overall process and what the company wanted to implement. PLG then created a set of business scenarios in coordination with the client’s main stakeholders. Each scenario has internal communication, actions to be taken and specific deliverables, which we’re all tightly managed by PLG.
Once satisfied, the client instructed PLG to execute the migration. The second arm of PLG’s expertise was called into play, Project Management. PLG managed the communication among all stakeholders, preparing them for upcoming changes and guiding them throughout the entire process with support for questions, alleviating any concerns.
In parallel with the project management services, PLG implemented the Migration and Testing phases. It was understood that the data migration would be implemented in different phases. The first part was an analysis of the client’s data to be migrated. Following this, we supported our client’s journey through IDMP gap analysis, data enrichment, and execution of test submission processes. In post-testing after the migration, the data was validated to maintain integrity.
The project was concluded with the training of all stakeholders. We prepared training materials, videos, e-learning content, user manuals and rewrote the SOPs for the company.
As alluded to previously, the client’s number one choice to support them in this project was PLG. This was because we had consolidated experience working on the RIMS software of their choice (in this case Veeva Vault). PLG’s experts besides having the experience were intimately familiar with the Health Authority requirements for IDMP integration into RIMS.
Our globalised approach to the challenges faced by the client allowed them to visualise an end-to-end RIM system in which the migration process itself was part of the system setup. Coupled with this vision, PLG’s fully developed service portfolio provided additional avenues for future integrations (XEVMPD, LCM, Serialisation, Artwork management etc.)
Within the project, an additional value provided by PLG and often singled out by the client was our Project Management and communication. The ability to keep all stakeholders updated, maintain clear lines of communication, delegate specific objectives and deliverables, and resolve conflicts promptly, all to maintain the efficiency of the project moving forward.
Technology is always becoming more refined and it is the job of our experts to stay on this cutting edge and bring advantages to our clients. PLG’s experts are always supported by an operational team with significant experience in their related fields. Learn how ProductLife Group can become your partner, welcoming you into the technological future.
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