As the medical industry keeps evolving, more companies are turning to RIMS software to help streamline everyday workflow, maintain records, and make sure that regulatory measures are being met.
Regulatory Information Management Software (RIMS) Explained
Regulatory Information Management software is a growing software that supports and facilitates a medical manufacturing organization’s process for planning, communication, collection, and storage of regulatory information. Regulatory information plays a vital role in the life science industry. It provides details of individual products and allows portfolio oversight.
In the medical industry, RIMS helps to streamline the submission of medical products. These include medical devices, drugs, biologics, cosmetics, and more. In other words, RIMS plays a significant role in providing the correct information, in the proper format and at the right time. It supports many cross-functional processes, including clinical trials, manufacturing, quality assurance, and more.
Benefits of Using RIMS Software
The medical industry needs a strong, practical, and unified system to help protect sensitive data records. Otherwise, you will run the risk of non-compliance and increased production costs. Here are three reasons why you need to use RIMS software.
Increased Efficiency and Productivity
RIMS has matured the past ways of doing work. It has replaced solely standardized manual labor with machines. With the innovation of information data standards like IDMP, RIMS enables companies to provide correct information to the right audience at the best time. RIMS also aims to avoid duplicated effort and redundancy. By centralizing data, the work gets done faster and in line with the requirements. RIMS also offers greater visibility into regulatory activities. That means teams can benchmark and focus on new markets and other product milestones. Increased regulatory efficiency means increased productivity. It also means reduced risk of non-compliance or having your products pulled from the market.
Regulatory Compliance
Pharmaceutical and medical device production is a sensitive industry requiring regular regulatory approval of new products. On the other hand, regulatory approval is more complex than proving ongoing compliance and can have substantial financial effects if not done correctly. If a new device or drug is rejected, it can take a couple of months or even years before you reapply. Using RIMS can help reduce the risk of human error, ensuring your product meets the requirements set forth by responsible authorities. This will save you money and time in the long run.
Streamlined Process and Speeds Time Into Market
RIMS helps medical providers manage data for the current and upcoming devices during and after the product manufacturing and registration phase. All of this data can be used to streamline regulatory activities across the product’s lifecycle. Before a company releases a product, it offers access to regulatory intelligence. For current products, RIMS helps to monitor relevant changes. This automated monitoring can allow the RA team to accommodate changes that might affect the selling of the product.
This results in greater operational agility, allowing organizations to track all their regulatory data simultaneously. Organizing and combining structured and unstructured information into a single system streamlines the hectic product registration, submission, and monitoring efforts. This helps to accelerate time in the market. Leveraging the RIMS system also helps businesses to advance in their digitalization journey. It allows companies to rely more on structured data than on documents. This helps them to progress faster and more efficiently in the market.
Is RIMS Worth It?
The short answer is it depends. Not all RIMS are helpful. Some RIMS fail to take advantage of the advanced innovation that delivers quality and efficient workflow. Innovation means current technological advancements, such as AI applications. AI has changed the way we live our lives. It has helped many industries grow, including the medical sector. The medical industry is ever-changing, and it must meet the needs and requirements of patients. Without RIMS means RA team will strive to deliver more than they could.
An influential RIMS can help manage and control the process of manufacturing and releasing medical products. It helps produce compliant submission documents and review and track them appropriately. It also plans, compiles, and publishes managing submissions. Overseeing original and lifecycle submissions and fulfilling regulatory compliance of electronic systems (21-CFR-Part 11) are combinations of reasons why you should utilize the full capabilities of RIMS.
Conclusion
RIMS software can transform the medical industry more than you can imagine. Adopting it can help bring your company closer to the customers than ever before. In turn, you will have an edge in a competitive and complex market that will yield great ROI in the future, all why making sure compliance measures are met.
