Infographic: 10 Common Pains in Dossier Management & Product Registration

Issue link:

Contents of this Issue


Page 0 of 0

10 Common Pains In dossier management & Product registration 1. NO SINGLE SOURCE OF TRUTH It's hard to ensure that your entire organization is using current documentation if users are spread across the globe using different systems. You need a single source of truth—preferably a fully automated, web-based system as the repository for all artifacts. To successfully introduce your medical device throughout the world, you must address these common challenges. 3. COMPLEX GLOBAL REGULATIONS Each market's requirements grow exponentially when the artifacts are just dissimilar enough from market to market to create confusion. You must keep up with an evolving interna- tional regulatory landscape. 4. MOVING TARGETS Product expirations, registration deadlines, and compliance requirements across multiple mar- kets are all moving targets. You need to be able manage all of them efficiently. 6. WASTED BUSINESS INTELLIGENCE If your system lacks reporting capabilities, you won't be able to see the big picture resulting from those trends. That means you're not utilizing product information you already have. 9. SILOS CAUSED BY DISPARATE SYSTEMS Multiple systems that are not connected help create silos that weaken team work. You need a platform that will connect all stakeholders regardless of geographic location. 10. NO ROOM FOR GROWTH Manual tools don't accommodate complexities in regulatory requirements or the growth of your orga- nization. The more products you have and the wider your market reach, the more you need a scalable system. 7. INCONSISTENT FILINGS Disparate systems can lead to inconsistent filings, which are prone to errors. These issues can result in submission delays, or worse, noncompliance. 2. LACK OF VISIBILITY Project visibility is crucial for regulatory personnel dealing with multiple products and markets worldwide. Equip your stake- holders with the right tools for project transparency by region and product. 5. DELAYED SUBMISSIONS The inability to nail down moving targets can lead to delayed submissions. This is a common pain among organizations that rely on spreadsheets and manual tools. 8. INEFFECTIVE COLLABORATION Lack of transparency can lead to ineffective collaboration, which in turn can jeopardize compli- ance. Companies with teams scattered in different cities or countries need a virtual collaboration

Articles in this issue

view archives of Infographics - Infographic: 10 Common Pains in Dossier Management & Product Registration