Regulatory Affairs

Pharmaceutical Regulatory Compliance

Sparta Systems' regulatory compliance management software solution meets the needs of regulatory affairs professionals responsible for all communications and correspondence required by the health authorities. Providing a centralized repository to manage global product portfolios, the system provides both worldwide and local views into product information, delivering an efficient, cost-effective global solution for all required regulatory tasks pertaining to new products and product lifecycle management.

Sparta Systems' regulatory compliance solution integrates with other critical network systems and processes to build a regulatory compliance system so there is no need to manage data in two places; the compliance software can be automatically updated with the latest data, globally. Regulatory affairs workflows are streamlined and time to market improved by providing users with efficient regulatory tracking tools to replace time consuming and error-prone excel spreadsheets and other manual tracking processes.

Benefits of Sparta Systems' Regulatory Compliance Software Solution:

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

Why Pharmaceutical Companies Need Enterprise Quality Management Systems

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