Every day device manufacturers face challenges, especially if they have products in multiple countries. This can be from business needs or local demands or regulatory compliance that needs to be maintained for those countries. With limited resources (and time) it’s tough to track what’s needed and what’s the impact for product changes is tough and may lead to burnout of resources. Other bigger risk is when people leave, all the product activity, regulatory communications, and requirements are either gone or stuck in email boxes that will be very tough to pull them out meaningfully.
Other challenges include:
- Manufacturers looking forward to expanding their scope globally often fall short to keep a track of the time and place of registrations, what’s due, when, and what document versions used in those dossiers
- The registration procedure is completely separate from the device data and hence keeping track of the both becomes difficult and this leads to never-ending excels after excels
- The global changes in regulations are a continuous process and maintaining compliance is challenging as these country regulations may not be in English and increase your dependency on everything and anything
- When a change request comes in, to do impact analysis becomes a mini-project in itself gobbling a lot of Regulatory member time.
A proper Regulatory & Submission management tool can help minimize pain. A cloud-based intuitive system increases productivity and efficiency as well while maintaining proper compliance
Some Benefits of Regulatory system:
- Revenue: Eliminates license renewals and other commitments date miss out risk. Also ensures minimize compliance issues that usually are a drain of internal time for audits, CAPAs, etc
- Confidence & Strategy: Know exactly what product is what stage in what country accurately. This will help make companies make the right decisions with new products or life cycle changes as there will be constant changes from marketing and commercial teams on posing different scenarios and options frequently. Right information can help you give strategic inputs for different scenarios
- Dossier builds: With proper Reg Intel built-in, a Reg data system ensures you get the right dossier checklists by country accurate and UpToDate all the time, This will lead to delays in HA/NB queries or rejections.
- Regulatory source of truth: A proper system tries to bring together accurate information from various functional areas into one place. This tends to increase the efficiency of the organization as it can use accurate details without having to collect it repeatedly.
- HA/NB formats: The same data goes to different countries in diff formats, not just the dossiers or tech files but going forward in digital formats of UDI in different countries coming up (EU, Australia, China). One tool to churn out these formats easily is a big help to teams to avoid mistakes and duplication.
If you want to explore what features will benefit you, please do a ViSU demo and decide if it’s a value or not to your company