Regulatory Affairs for Pharma & Biotech

Managing Regulatory Compliance

The Sparta regulatory compliance management solution meets the needs of regulatory affairs professionals responsible for all communications and correspondence required by the health authorities. It provides a centralized repository to manage global product portfolios, delivering an efficient, cost-effective way to manage regulatory tasks pertaining to new products and product lifecycle management.

It integrates with other systems and provies real-time data on a global scale. It helps streamline RA workflows and improves time-to-market by providing users with tracking tools that replace time consuming and error-prone excel spreadsheets and other manual tracking processes.

 

Benefits of Sparta's Regulatory Compliance Software Solution

  • Provides a closed-loop between change control and regulatory submissions.
  • Manages regulatory tracking and all phases of the regulatory compliance process, product life cycle, and submission process.
  • Facilitates global compliance by reporting on registration status by country, product type, indication, dosage or any other classification.
  • Integrates with document and change management, SOP tracking, Clinical Trial Document (CTD), and regulatory auditing.
  • Manages and tracks correspondences with health authorities along with resulting commitments and tasks.
  • Manages and tracks regulatory notifications or approvals as a result of change controls initiated by other parts of the organization.
  • Manages and tracks regulatory reporting processes including product safety update reports (PSURs), with links to original submissions.
  • Ensures faster response time to resolve findings or warning letter issues.
  • Provides real-time access to relevant health authority correspondence and commitment information to all the individuals involved in answering commitments.
  • Provides access to source regulatory correspondence documents by integrating with a document management system.
  • Increases speed and accuracy of commitments responses.
  • Eliminates redundant systems and reduces repetitive and manual data entry.
  • Improves control and consistency in the commitment management process.
  • Reduces errors and decreases repeat inquiries from health authorities.

Regulatory Affairs Processes

Capture, manage, and track all communications, correspondence, product registrations, submissions, and commitments to health authorities. 

Questions you need answered?

Contact Us
© 1995-2017 Sparta Systems, Inc. All Rights Reserved.
© 1995-2017 Sparta Systems, Inc. All Rights Reserved.Sparta Systems Logo