DeviceWatch can now link signals to the CAPAs that follow them up and point each CAPA at its record in your eQMS. One signal can link to several CAPAs and one CAPA can cover several signals. You can search by your own CAPA number, and the CAPA Summary report lists the references and linked signals. The DeviceWatch 0.6 release includes this workflow as part of Compliance Pro.
Why the link matters
A signal in DeviceWatch is a pattern worth investigating: a run of similar MAUDE reports, a failure mode that keeps appearing or a recall that touches a product you track. The investigation usually lives elsewhere. Most teams run CAPAs in an eQMS, where the root cause, actions and effectiveness checks are recorded.
Before this release, DeviceWatch allowed one CAPA per signal and had no place for the eQMS reference. The trail from “we saw this in the FDA data” to “this is the CAPA that handled it” depended on someone remembering to write it down.
What changed
- Link one or more signals to an existing CAPA or a new one, and link one CAPA to several signals when a single investigation covers more than one pattern.
- Record your organization’s CAPA number and a link to the record in your eQMS.
- Search CAPAs by that number.
- From a signal, browse the linked event evidence and jump back to the CAPAs that cover it.
- CAPA Summary reports include each CAPA’s reference and its linked signals.
The many-to-many link reflects how investigations run. A firmware fault can show up as two signals, one for display failures and one for unexpected restarts, and both belong to the same CAPA. A broad CAPA on a supplier change can absorb signals that appear months apart.
What DeviceWatch does not do
Your eQMS remains the source of truth. DeviceWatch does not sync with it, read from it or certify that a CAPA is complete or effective. The status, owner and due date on a DeviceWatch CAPA are follow-up details your team maintains by hand, and the app now labels them that way.
A surveillance tool that claimed to know a CAPA’s real state would be guessing, and an auditor would ask which record wins. DeviceWatch records the connection between the FDA evidence and your CAPA.
Audit entries and safe retries
CAPA link and reference changes are written in the same transaction as their audit entries, so a link never exists without the record of who made it. Existing CAPAs and any historical duplicates stay intact. Creating a CAPA is safe to retry: a double click or a dropped connection does not produce a second record.
A follow-up fix in 0.6.0.1 protects concurrent edits. If a linked signal changes while you are editing a CAPA, the page refreshes without losing the revision you started from, so stale form values cannot overwrite another reviewer’s changes.
Who it is for
If your team already watches MAUDE and recall data in DeviceWatch and runs CAPAs in a separate eQMS, this links the two. Signals and CAPAs are Compliance Pro features. Growth covers core surveillance, recalls, clearances and trend reports.
The Help Center has a signal investigation playbook that walks through the flow from event to signal to CAPA.
More at devicewatch.app.