FDA’s Guidance on 510(k) Submission for a Software Change to an Existing Medical Device
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While creating compliant packaging, controlling the labeling flow and its implementation through artwork, supply chain and printing involves several internal and external stakeholders. Following up with all the teams to meet the time-critical mandates and deadlines can be challenging. Therefore, it is crucial to have a dedicated platform to handle the lifecycle changes of product labeling. 

With numerous Labeling software in the market, identifying the suitable software for your product is paramount. Here are a few key factors to keep in mind while choosing the Labeling software.

  • The software must have various integrated modules for label development, implementation tracking and real-time Regulatory intelligence that helps to develop/renew products from formulation to launch. 
  • The primary factor to consider is that the software must comply with all the major global Health Authorities.
  • The software must help in maintaining effective collaboration with both internal and external stakeholders as all the participants are not involved at the same time in a particular project.
  • All the tasks in the project must follow a specific order. One slight delay can impact the entire project. Therefore, it is necessary to track all the tasks to analyze the project progress and understand the pain points.
  • The software must have a centralized and easily accessible repository to store all the documents and data in pre-defined templates.
  • The software must provide a global view of the whole project for better management and decision-making.
  • It must track the communication between both global and local teams.
  • It must have a dedicated global and local impact assessment.

With multiple advancements in the Life sciences industry, manufacturers must continuously strive to find new approaches as per the latest market trends. The more effective way to streamline the entire lifecycle of Labeling is to opt for a proven Regulatory Labeling Software. Choose a one-stop solution like Freyr LABEL 360 for all your Labeling needs.