Rising Expectations from Regulatory Affairs Executives
As we all know from experience, not all cloud solutions are the same and cloud-based regulatory information management (RIMS) has to go further than simply managing solutions if it’s going to bring break-through change to regulatory affairs.
Take for example the way all employees, globally, use the system. A simple user interface with a process-based approach is important to make it easy for less frequent users of the system – such as affiliates – to upload and download submission information without the need for training. It’s not just about making those employees lives easier but also ensuring that regulatory affairs have information about the status of products across multiple markets provided promptly and stored in a central database.
Adoption of life sciences industry best practices and the opportunity to benchmark against peers in order to improve efficiencies, faster deployment and validation and access to quick upgrades without the need for customization are other important considerations.
In addition, wizards, workflow-driven activities and reminders help to improve forecasting and submission planning and thus enhance productivity. And real-time visibility and capabilities such as medical coding against controlled vocabularies ensures high-quality data is collected in a timely fashion, while improving the electronic regulatory submission process.
Can Regulatory Compliance and Efficiency Co-Exist?
Let’s backtrack to what has prompted this need for a more automated and integrated approach. The entire regulatory life cycle is under the spotlight. From development to submission pressures are mounting as regulatory requirements increase and as the focus on compliance audits intensifies.
Regulatory affairs departments must also tackle a string of business challenges: gaining affiliate participation in the rollout regulatory information management systems (RIMS); poor real-time visibility into the authorization status of submissions; pressure for greater forecasting, processing planning and productivity tracking; and the risks posed by dated technologies and costly upgrades.
In this environment, the ability to make decisions more accurately and efficiently, to meet compliance requirements and to reduce overall costs is pressing.
Thus, rather than a piecemeal approach to managing regulatory affairs processes, companies want a regulatory solution that connects all the cogs in the machine: product and clinical trial registrations, submission planning and forecasting, agency interactions, global change management, and performance tracking. A mature Industry Standard Practices driven Cloud-based RIMS allows central regulatory departments to address these needs of central, regional and affiliate organizations in an overarching process driven approach that is based on best practices from the industry.
On top of these, companies want a simple way to address industry standards, including Identification of Medicinal Product (IDMP) compliance, Extended EudraVigilance Medicinal Product Dictionary (xEVMPD) compliance and other regulatory data standards. The right Cloud-based RIMS can enable regulatory affairs to maintain a validated source of truth about all products globally in a central standards compliant data hub, and re-use approved product information it to generate and electronically submit multiple data submission packets to be compliant with these standards.
We don’t believe these should be out of reach for regulatory affairs. On the contrary, we believe power and simplicity, efficiency and reduced total cost of ownership, and next-generation decision making combined with better compliance should go hand-in-hand. That’s why we’ve launched the LifeSphere® Regulatory solution – a TCO approach to solving the most complex regulatory challenges.