PlatformCAPA
CAPA software where every CAPA is its own record
An event is something that happened. A CAPA is something you commit to do. QMSdesk™ CAPA software gives every commitment its own record, its own reviewed plan and its own proof that the fix held.
CAPA-001
Temperature excursion during storage, batch BT-4201
Workflow
Step 4 of 6: Implementation
- Source
- DEV-001, signed CAPA decision
- Raised with the plan
- Change control CC-003, training
- Effectiveness check
- Scheduled after closure
From first signal to proven fix, on one page
01
Start where the problem shows itself
Raise a CAPA from a deviation, a complaint, an audit finding, a trend, a management review or your own observation. One CAPA can address several events at once.
02
Plans that bring their own follow-through
When QA approves the action plan, the change control and the training it needs are raised with it, before implementation starts.
03
Fixes you can prove
Effectiveness verification can't be skipped. After closure, a scheduled check confirms the effect held, over the interval you set.
How CAPA management software should run
Every CAPA in QMSdesk follows the same locked lifecycle, with signatures where decisions are made.
Step 1 of 6
Reported
An owner and a severity are set, and the CAPA is linked to whatever prompted it, or to nothing.
Step 2 of 6
Investigation
The root cause and its category are recorded.
Step 3 of 6
Signed stepAction plan review
QA reviews the corrective and preventive actions. The person who investigated can't sign this review.
Step 4 of 6
Implementation
Each action item carries its own owner, due date and evidence. For moderate, major and critical CAPAs, QA reviews every item.
Step 5 of 6
Signed stepVerification
Were the actions implemented, and were they effective? No path to closure skips this step.
Step 6 of 6
Signed stepClosed
The closure records a summary and lessons learned, and schedules the check that the effect held.
CAPA software built around the commitment
CAPA without an event
Some of your most important CAPAs have no triggering event: a trend across a quarter's deviations, a management review decision, an audit observation. In QMSdesk they're raised directly, with a typed link to their source. ICH Q10 names the CAPA system and change management as peer elements, and QMSdesk models them that way.
A CAPA effectiveness check scaled to risk
Each closed CAPA carries a scheduled check that its effect held, over the interval you set. If the effect didn't hold, QMSdesk raises a new CAPA, linked to the original. The signed record stays exactly as it was, so anyone reading it later sees two decisions, not one rewritten history.
Action items with their own evidence
Every action has an owner, a due date and evidence. QA accepts or rejects each item for moderate and above, and the CAPA can't leave implementation until every item is done.
Risk stays in step
A critical risk raises its CAPA automatically, once. When a CAPA closes, or proves ineffective, its risk returns for re-assessment by a person. An event's CAPA is always raised by a signed CAPA decision, never automatically on logging.
Feature index
Everything in CAPA
The record
- CAPA as its own record, a peer of change control, with its own number and retention clock
- Origins linked, never contained: events, audit findings, trends, management reviews, observations, or none
- One CAPA addressing several events, through typed, attributed links
- Cancelled with a signed reason, never deleted
The lifecycle
- Reported, then Investigation, then Action plan review, then Implementation, then Verification, then Closed
- Signed action-plan review, verification and closure, each with a recorded meaning
- The investigator can't sign the action-plan review
- Action items with owner, due date and evidence, and QA review per item for moderate, major and critical CAPAs
- Change control and training raised at plan approval
- Effectiveness verification that can't be skipped
After closure
- Scheduled effectiveness checks after closure, over the interval you set
- A failed check raises a new linked CAPA and never reopens the signed one
- The linked risk returned for re-assessment when a CAPA closes or proves ineffective
How a CAPA gets raised
- By a signed CAPA decision on an event, in the same transaction as the signature
- Automatically, once, for a critical risk
- Directly, from a trend, an audit finding, a management review or an observation
Oversight
- My Work, the review queue and deadline escalation from owner to Quality Manager
- Event trending by type, severity, site, product and root cause, to find the CAPA no single event shows
- Recorded in the SHA-256 hash-chained audit trail
One connected system
Connected across QMSdesk
CAPAs start from quality events, audit findings and management review.
The approved plan raises its change control and training.
Risk management raises a CAPA for a critical risk, and re-assesses the risk when the CAPA closes.
Regulations
Regulations it's designed to support
QMSdesk CAPA is designed to support corrective and preventive action controls under:
- ICH Q10 §3.2, where CAPA and change management are peer elements of the quality system
- The FDA QMSR, which incorporates ISO 13485:2016 by reference, so CAPA now sits in ISO 13485 §8.5.2 and §8.5.3. QMSdesk is built to support organizations working to ISO 13485:2016, including §8.5.2 and §8.5.3
- 21 CFR 211.192, for the investigations that lead to a CAPA, under the GMP profile
- 21 CFR Part 11, for every signed CAPA decision
Questions buyers ask
Can we raise a CAPA without an event?
Yes. A CAPA can start from a trend, an audit finding, a management review or an internal observation, with no event at all. Its source is a typed link, so the CAPA keeps its own lifecycle.
Does a critical deviation create a CAPA automatically?
No. Major and critical deviations go to a signed CAPA decision, and a "CAPA required" decision raises the linked CAPA in the same transaction. The automatic path is for risk: a critical risk raises its CAPA once.
What happens if an effectiveness check fails?
A new CAPA is raised and linked to the original, which stays closed and signed. You can read both decisions, and why the second one was needed.
Who reviews the work on each action?
For moderate, major and critical CAPAs, QA reviews the evidence for every action item. For minor CAPAs, the owner completes each item with evidence, and QA verifies the work as a whole at the signed verification step.
Commitments that get done, and proven
Bring a CAPA backlog, or one CAPA that keeps coming back, and we'll run it through QMSdesk with you.