CASE STUDY
A mid-size pharma company was facing challenges in managing and keeping track of their Dossier document submissions for multiple markets. Each team was maintaining the monitoring information through siloed excel sheets, there was no centralized location and view to understand and track the full progress on the readiness of regulatory submission documents.
After carefully analyzing the situation, our experts decided to take a customized approach using digital ppm tools. The client was already using O365 with Project Online, leveraging this, our team advised a plan to use their existing Microsoft Project Online application to digitally transform the Dossier document management. This gave the client the advantage of digital PPM tools with no additional licensing fee.
Our project management experts first identified the steps involved in the life cycle of each document, they then chalked out the structure of the submission plan along with roles and responsibilities at each stage. This helped in efficient tracking of each document throughout its journey.
Next, the team suggested to created separate sections for each module within the submission plan using Project Online and assigning roles and responsibilities. The team and the project managers were trained on how to use Project Online to update their daily weekly progress once each submission task was completed. As the submission plan kept progressing, the project manager was able to track the whole project’s progress from one central location with just a click.