The regulatory affairs department has a significant role to play in product recalls. Responsible for protecting public health, this team ensures organizations comply with safety standards, health legislation, and, of course, recall notices.
Without the regulatory affairs department, organizations can’t adhere to recall management protocols effectively. It’s as simple as that. However, this department often struggles to communicate important safety information to other teams because of inefficient digital tools. In this post, we examine the role of the regulatory affairs department in product recall management scenarios.
What Does the Regulatory Affairs Department Do?
The regulatory affairs department ensures an organization “plays by the rules” concerning public safety. Commonly found in heavily regulated sectors, such as pharma, food/beverages, and medical devices, this department has various roles and responsibilities:
- Make sure products, materials, and components adhere to the most current legislation.
- Keep up-to-date with the latest product safety guidelines/laws.
- Carry out regulatory inspections.
- Report to the relevant public safety authorities
- Communicate with other teams about public safety issues.
- Respond to product recall notices from the government.
In short, the regulatory affairs department bridges the gap between an organization and federal government agencies such as the FDA.
In some industries, such as pharma and medical devices, faulty products and materials can endanger lives. This public safety risk is why the regulatory affairs department is so valuable. But teams often struggle to fulfill their regulatory responsibilities because of poor communication and outdated software.
What Challenges Do Regulatory Affairs Teams Come Across?
Regulations and guidelines from the government often change without a moment’s notice. For example, the FDA might deem a particular material unsafe. It’s the job of the regulatory affairs department to monitor the latest legislative changes and maintain compliance.
If an organization doesn’t comply with the latest government guidance, there could be strict penalties. These include civil fines and criminal proceedings. But it’s not just the government that can take action. Sometimes, people might sue an organization if manufacturing processes or products don’t meet the required regulations. These lawsuits are costly and can damage the reputation of a brand.
Other challenges are technological. Regulatory affairs departments need to communicate information to other teams (legal teams, operations teams, managers, etc.). A communication breakdown can cause non-compliance and fines from the government.
The problem is that many regulatory affairs departments don’t have the digital tools they need to complete important tasks. Legacy software and outdated programs increase errors. Teams that still rely on manual methods can also run into trouble. To improve product recall responses, regulatory affairs teams need reliable software that automates many of the tasks associated with recalls. The right software makes it easier to comply with the government, protect the public, and avoid lawsuits.
What Digital Tools Should Regulatory Affairs Teams Use?
There are various types of software for regulatory affairs teams, but few provide them with the capabilities they require. Some teams use ERP or CRM systems (like the rest of their organization), but these lack the features to manage and respond to recall notices quickly. There’s also the problem of too much software, which can complicate matters.
Imagine if regulatory affairs teams had one piece of software for recall management. It would improve product recall response times considerably.
A product recall management system like Trievr proves useful for teams. It automates many of the tasks associated with recall management and reduces software bloat. Regulatory affairs teams can use this software to manage product recalls and communicate more effectively with other teams in their organization.
Learn more about Trievr here or try a 15-day free trial.
What Are the Benefits of Trievr?
Trievr is your one-stop recall management platform, with lots of features for handling product recalls. These features include:
- Auto-alert reminders so regulatory affairs teams can complete tasks on-time and meet deadlines
- Product recall templates so teams can streamline recall management
- Collaborative tools so all teams in an organization have access to the same information
- Enhanced security to safeguard sensitive recall information
- Cloud capabilities so organizations can store recall information safely and access data from any location
- On-demand pricing so organizations only pay for recall management features they require — no monthly/annual fees
Trievr is a SaaS-based recall management platform that provides regulatory affairs teams with more value.
Final Word
Regulatory affairs don’t have to be a complicated affair with the latest digital tools. Teams that use a recall management platform can handle all the tasks associated with product recalls and ensure other departments comply with the government.
Are you looking for an effective product recall management solution for your regulatory affairs department? Trievr is the on-demand cloud-based platform that optimizes product recall responses. Learn more here or sign up for a 15-day free trial.