Learn about the signal management process.

About Signal Management

The signal management process identifies, tracks, and investigates safety issues that may be related to a medicinal product. SafetyDocs supports the signal management process based on GVP Module IX guidelines. According to GVP Module IX, signal management should be completed in the following order:

  1. A signal is detected through a signal detection process or a Literature Review.
  2. The signal is assessed and its validity is determined.
  3. If the signal is valid, an investigation is performed by reviewing all available data from Cases and Inbox Items.
  4. Based on the investigation outcome, the signal is either confirmed or refuted.
  5. If the signal is confirmed, further actions are taken such as putting the related product on a watchlist, updating labels, or creating a risk management plan and submitting it to a regulatory authority.

Signal management in SafetyDocs provides the ability to track signals after detection and progress through the steps above while maintaining accurate signal-related records. This feature’s capabilities include:

Prerequisite

Your Admin must enable Signal Management in your Vault.

Working with Signal Documents

When uploading signal-related documents, use the Signal Management document type and the appropriate subtypes and classifications.

Upload Signal Management documents using the same process as for other document types.