PlatformQuality events
Quality event management software, one workflow per event
Every incident, deviation, complaint and out-of-specification result can be recorded the moment it happens and follows the path its type and severity call for. QMSdesk™ quality event management software gives each kind of event its own signed workflow, and connects it to the CAPA, risk and training that follow.
What changes when every event has its own path
01
Everything gets reported
Anyone in your organization can report an event, and control applies from triage onward. An operator on the night shift records a deviation in the system, not on a sticky note.
02
Nothing quietly disappears
A record raised in error is cancelled with a signed reason, never deleted. It stays readable, keeps its number, and drops out of your counts and deadlines.
03
Late never means stuck
A missed deadline escalates, from the owner to the coordinator to the Quality Manager, but it never blocks the work. The step that ran late records why.
How a quality event workflow runs
Step 1 of 5
Report
Anyone raises the event, whatever its type.
Step 2 of 5
Contain
Major and critical incidents and deviations start with containment. Minor ones take a shorter path, so effort follows risk.
Step 3 of 5
Investigate
The investigation and its root cause are recorded on the event.
Step 4 of 5
Decide
For most event types, a named person signs the CAPA decision. When a CAPA is required, the linked CAPA is raised in the same transaction as that signature. A critical event also prompts a risk assessment, which a person makes.
Step 5 of 5
Close
The closure is signed, and a closure-record PDF with the full signature manifest is ready to download.
Quality event management software for every event type
Six event workflows come with every QMSdesk tenant. The busiest have pages of their own.
Incident management for GxP teams
Incidents and near misses are easy to report. Containment is required for major and critical incidents, and the signed closure records the CAPA decision, so even a near miss leaves a documented answer to "does this need a CAPA?"
Deviations and nonconformances
Deviations route by severity, and nonconformances carry a signed disposition. See deviation management.
Complaints
Acknowledgment tracked against a 3-business-day deadline, a signed reportability review and a customer response. See complaint management.
OOS and OOT results
A two-phase investigation that can't be skipped, with lab-error trending. See OOS investigation.
Supplier issues
A SCAR your supplier answers through a single-use link, with signed response review, verification and closure. See supplier quality.
Workflows your regulatory profiles add
Hold the GMP profile and batch deviations, environmental excursions and product recalls appear. Hold GLP and you get a study-deviation workflow with Study Director sign-off within one day. Hold Healthcare and a patient safety event always requires a CAPA. Your regulatory profiles decide which workflows you run.
Feature index
Everything in quality events
Event workflows in every tenant
- Incident, deviation, nonconformance, complaint, OOS/OOT, supplier issue (SCAR)
- CAPA as its own record, linked to the events it addresses
Workflows added by regulatory profiles
- GMP: batch deviation with 1-day containment, environmental excursion, product recall
- MDR: vigilance on the complaint workflow, post-market surveillance event, UDI and serial number on nonconformances
- GCP: protocol deviation
- GLP: study deviation (6 steps) and QAU finding (5 steps, management notified within 7 days)
- Contract operations: QA-agreement deviation, tech-transfer issue
- Healthcare: patient safety event, HIPAA breach, adverse drug event, near miss
- ATMP: process nonconformance, 503A pharmacy: medication-dispensing nonconformance
Controls on every event
- Anyone can report; control applies from triage
- Severity sets the depth of the workflow
- Signed decisions at the steps that matter, each with a recorded meaning
- Cancelled with a signed reason, never deleted
- Deadlines that escalate but never block, with delay reasons on late steps
- A reminder ladder from owner to coordinator to Quality Manager
- CAPA raised in the same transaction as the signed decision that requires it
- Typed, attributed links between any records
- Numbering that's never reissued
- Closure-record PDF, with every download logged
Seeing the whole picture
- My Work and a cross-module review queue
- An in-app inbox as the system of record
- Event trending by type, severity, site, product and root cause
- OOS lab-error trending by method, analyst and instrument
One connected system
Connected across QMSdesk
A signed CAPA decision raises the linked CAPA, which carries its own change control and training.
A critical event prompts an assessment in risk management.
Supplier issues feed the supplier's record in supplier quality.
Events feed the Command Center and event trending.
Regulations
Regulations it's designed to support
Quality events in QMSdesk are designed to support investigation, complaint and nonconformance controls under:
- 21 CFR 211.192 (investigation of discrepancies) and EU GMP, under the GMP profile, with Annex 11 record controls
- The FDA QMSR. QMSdesk is built to support organizations working to ISO 13485:2016, including §8.2.2 and §8.3
- 21 CFR Part 11 for every signed decision
Questions buyers ask
Which event types does QMSdesk include?
Six event workflows come with every tenant: incident, deviation, nonconformance, complaint, OOS/OOT and supplier issue. CAPA is a record in its own right. Your regulatory profiles add their own workflows, such as batch deviation, protocol deviation or GLP study deviation.
Does a critical event raise a CAPA automatically?
No. An event's CAPA is raised by a signed CAPA decision, made by a named person. A critical event also prompts a risk assessment, which a person makes. That keeps every CAPA attributable to the decision that required it.
What happens when a step runs late?
The record is flagged overdue and escalated, but it stays fully workable. When it moves on, the late step records a delay reason, and the breach stays on the record.
Can someone delete an event raised in error?
No one can delete it. The person who raised it, or a Quality Manager, can cancel it from its first step with a signed reason. It stays readable and keeps its number.
Every event, on the path it deserves
Bring an event type you handle today, and we'll run it through QMSdesk with you, from first report to signed closure.