Why is your regulatory data stored in regional silos?
Why is there a requirement for inter-departmental data requests?
Why does it take 3 days, 3 weeks, 3 months to find what you are looking for?
Why must the regulatory team triple check spreadsheets for data accuracy?
Why are weekly registration update meetings scheduled throughout your diary?
- Data secreted into limited access, regional silos supports the notion that only those personnel in the region “understands” the data, knows where the data is located, and whether or not it is accurate. This is not an efficient or sustainable process, which may actually increase internal expenditures.
- Whenever regulatory staff move on, you immediately lose access to your data history. Resource, already drained, is now allocated to rebuilding the historical knowledge back into those antiquated spreadsheets to repeat the cycle.
- Take into consideration and analyse the value return on the salary earned by regulatory professionals performing rote administrative tasks. Automation definitely converts into the least expensive alternative.
- You have designed your medical devices to provide life-enhancing products for patients across many years, data compliance is not an option.
- When your organisation successfully maintains one Single-Place-of-TruthTM for your regulatory information, your limited resources are allocated to more value-added activities with the potential to increase revenue.
The speed in which medical device legislation is evolving is unprecedented. The challenges for regulatory compliance activities are further amplified due to the lack of globally harmonized efforts. The role of the regulatory professional in this new and complex data driven environment becomes even more critical. Take the time to perform lessons learned in order to drill down to discover the legitimate causes of missed submission targets and renewal deadlines, miscommunications with health authorities and regulatory staff turnover.
How can you continue to expect regulatory teams be responsible and accountable when they are unsure, uncertain, unaware and unsupported?
The realization of your innovative product development and continuation of a successful revenue stream depends on the competency of your global and regional regulatory teams. Are you sure your RA teams have all the necessary tools at their disposal?