Regulatory Affairs Software Systems


Life Science Companies and Regulatory Affairs Software Systems

For life science companies, the pressure lies not only in developing an innovative drug or medical device but in beating the competition to market. It is not enough to spend millions of dollars in product development, it is equally critical to be the first to market the new product. Timely product launch is greatly affected by compliance - the purview of the regulatory affairs team. In light of intense competition in the global market, life science companies are increasingly relying on regulatory affairs software to support their compliance efforts.

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How Regulatory Affairs Software Can Support Regulatory Affairs Teams

In life science companies, the regulatory affairs team is considered the "quarterback" because it is the leader in terms of compliance efforts. It is responsible for regulatory submissions and global marketing approvals. Just like a quarterback, the regulatory affairs team coordinates all other departments that have a bearing on product approval and compliance. So how can regulatory affairs software help your quarterback?

The regulatory affairs team is typically the primary group that communicates with the appropriate regulatory body (e.g., the Food and Drug Administration in the United States or the European Medicines Agency in the European Union). The more markets the company wants to enter, the more regulations and standards it must comply with, making an electronic regulatory affairs system indispensable.

Regulatory Affairs Software vs. Paper-Based Document Management System

Many companies still use paper-based document management systems, but bigger companies and other organizations that are keen on competing globally (regardless of their size) are likely to use regulatory affairs software. An electronic regulatory affairs system can help standardize and streamline the essential functions of a regulatory affairs team, including coordinating and managing regulatory submissions with the R&D, quality, manufacturing, clinical research, and other teams. This includes submissions for a new product (e.g., investigational new drug and new drug applications to the FDA in the United States) or marketing authorization applications (in Europe and other parts of the world).

After the product has been launched in the market, the use of regulatory affairs software can greatly speed up the preparation and submission of post-marketing reports to various regulatory bodies.

How MasterControl Regulatory Affairs Software Can Help You

MasterControl quality and compliance software is designed to help you comply with the most rigorous regulations and standards that exist today. It automates, streamlines, and connects all processes critical to compliance, including document management, training control, CAPA, audit management, and change control. The following features make it an effective foundation for your regulatory affairs system:

  • MasterControl EDM Reference Model JumpStart: The capability to manage and accelerate document submissions and correspondence with regulatory agencies is one of the hallmarks of robust regulatory affairs software. MasterControl EDM Reference Model JumpStart is preconfigured to do exactly that. It was developed based on industry best practices and regulatory requirements for life science companies. It includes:
    • Organizer Gateway: This regulatory affairs software tool allows users to export PDF documents used in submission publishing tools and at the same time maintain controlled source documents within the MasterControl system.
    • Submission Locker: Pharmaceutical, biotech, and medical device companies need a regulatory affairs system that offers support throughout the submission lifecycle. MasterControl Submission Locker provides a secure environment and a centralized location from start to finish of any submission. It is accessible regardless of the type of publishing tool preferred by users. For FDA-regulated companies, this tool allows users to maintain documents in the same format as their FDA submissions.
  • MasterControl Project: Project management should be an essential component of your regulatory affairs system. MasterControl Project automates and streamlines management of documents- and forms-based processes. Your regulatory affairs team will greatly increase efficiency in coordinating documentation from various stakeholders and managing submission timelines.
  • MasterControl Risk: Risk management is an important part of MasterControl's regulatory affairs software. With MasterControl Risk, you will have a single, web-based platform for all documentation and processes related to risk assessment and management. MasterControl will connect the different stakeholders under one system, making it easier for them to participate in risk management activities and reducing the likelihood of tasks falling through the cracks.
  • MasterControl API: If your organization uses different tools for publishing and submission, MasterControl API will allow you to integrate MasterControl with those other tools for a consolidated regulatory affairs system. You will be able to leverage all of your existing tools and at the same time use MasterControl for your quality processes such as document management, CAPA, training control, audit management, etc.

For More Information about MasterControl Regulatory Affairs Software Systems

For more information about MasterControl's regulatory affairs software system Contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.