As I sat and watched my family on their various devices over the weekend, they were all playing with the latest apps. I really wondered why should the kids (and the marketing people) be having all of the fun?
Is Regulatory Affairs content with less “fun” technology as we develop our strategies, get products to the market, and keep them there while complying with all of the regulations? Should only the marketing function have exclusive access to all the latest, cool toys for their work?There are many companies out there who are working with regulatory documentation management – some deliver on site solutions and others are cloud based. While this merits a blog on its own, my question today is a different one:
Are there tools out there that really make the operational part of regulatory affairs more efficient (and maybe more fun)?
When I asked this question in our office, I was answered with a question. (I do this with my kids sometimes so I understand the tactic.) If I could have a wish list in a regulatory planning/tracking system, what exactly would it contain?
Let’s start with the background. We can agree that it must be an efficient way to plan/track regulatory progress across various regions. It must be capable of keeping the mountain of information from the various countries accurate, up to date and effectively archived. I want even more than this.
So here it is, my wish list:
• Contains a product overview sheet that will provide an up to the minute, comprehensive regulatory summary on a specific product.
• Pulls up a view of country or product specific information with one click speed.
• Allows me to initiate new submissions in multiple countries and creates the appropriate submission backbones to get the process started.
• Allows me to assign tasks to individuals both within and outside of RA and helps me to track progress.
• Helps with resource allocation by tracking submission timelines and progress.
• Alerts me when post-marketing submissions are required and allows me to create the backbones for them.
• Allows me to set KPIs (i.e. submission to approval, time to answer deficiciencies) and generate reports (cool ones) for management.
–> I want something that goes much deeper than simply tracking individual submissions. I want an integrated snapshot at any time (that I can show to management) and something that really helps me to get my work done.
If this sounds like your dream too, then you should ask for a demo of Cunesoft’s product. We would love to hear if you would like to add to the wish list.