Query and deficiency management is crucial to ensure all obligations from agencies are tracked and answered in a timely manner to minimize non-compliance. In addition searching previous (or other country) queries and responses will help understand global queries and increases re-usability of utilizing that content instead of creating from scratch. Digitizing these also helps retain knowledge or activity when people leave company. Our solution fulfils some of the common requirements companies have like:
Query Submission: The system allows users to submit queries through a user-friendly interface (or can auto capture for emails as well). It includes fields for relevant information, such as the name of the product, query type, query description, and any supporting documents.
Query Assignment and Tracking: The system automatically assigns queries to appropriate person or functional department for review and resolution. It also tracks the status of each query, including any updates or notes.
Communication: The system also enables communication between stakeholders, both internal and external. This is done through the system’s messaging feature, which enables users to send and receive messages securely.
Reporting: The system provides reports on the number and types of queries received, the resolution time, and any trends or patterns identified. This data can be used to identify areas for improvement and to inform decision-making.
Integration: The system also integrates with other systems, such as a regulatory reporting system or a QMS or Vigilance system, to ensure that all relevant data is captured and shared.
HA Correspondence Centralization
Managing Health Authority (HA) correspondence efficiently is essential for regulatory compliance and streamlined operations. Our solution centralizes all HA communications, ensuring that submissions, queries, responses, and follow-ups are easily accessible in one secure location. By consolidating correspondence across multiple regulatory agencies and regions, companies can improve transparency, reduce redundancy, and enhance collaboration among internal teams.
With built-in tracking and categorization, the system helps users quickly retrieve past communications, maintain a clear audit trail, and ensure timely responses to regulatory authorities. Integration with query and deficiency management further strengthens compliance efforts by providing a holistic view of all HA interactions, ultimately minimizing risks and improving response efficiency.
