PlatformDeviations and nonconformances
Deviation management software that routes every deviation by severity
A minor slip is recorded and closed with one signature. A critical one is contained, investigated and decided, with the right people signing. QMSdesk™ deviation management software sends each deviation down the path its severity calls for, and gives every nonconformance a signed disposition.
DEV-001
Temperature excursion during storage, batch BT-4201
Workflow
Step 3 of 6: Investigation
- Containment
- Completed within 1 day
- Risk assessment
- Required by critical severity
- CAPA decision
- Signed, raises CAPA-001
Risk assessment required
Critical severity: a person assesses the risk before the investigation closes
Effort that matches the risk
01
Minor deviations stay light
A minor deviation takes the short path, closed with one QA signature that also records the CAPA decision. Reporting stays easy, so people keep reporting.
02
Serious ones are contained first
Major and critical deviations start with containment, then a full investigation. Nothing reaches a decision until the impact is understood.
03
Every decision has a name on it
The CAPA decision and the QA approval are each signed, with a recorded meaning. Months later, anyone can see who decided what, and why.
How deviation management software runs in QMSdesk
At the CAPA decision, "CAPA required" raises the linked CAPA in the same transaction as the signature. A critical deviation also prompts a risk assessment, which a person makes. QA can send an investigation back when it needs more work.
Major and critical deviations
- 1Reported
- 2Containment
- 3Investigation
- 4CAPA decisionSigned
- 5QA approvalSigned
- 6ClosedSigned
Minor deviations
- 1Reported
- 2Investigation
- 3ClosedSignedSigned by QA, with containment added when you need it
Nonconformance management software with signed disposition
When product doesn't meet requirements, the first question is what to do with it. In QMSdesk, every NCR starts there.
- Disposition first. Reject, rework, use as is or return, signed at the point of decision.
- Use as is, justified. Use as is needs a technical rationale before it can be signed.
- One signed QA act. QA approves the nonconformance and makes the CAPA decision together.
Under the MDR profile, nonconformances also record the UDI and serial number. The ATMP profile adds a process nonconformance for cell line, batch and critical quality attribute, and 503A pharmacies get a medication-dispensing nonconformance.
- 1Reported
- 2DispositionSigned
- 3Investigation
- 4QA approvalSigned
- 5Closed
Deviation management for pharma, labs and trials
Your regulatory profiles add the deviation workflows your work calls for:
GMP
Batch deviations with a 1-day containment deadline, and environmental excursions
GCP
Protocol deviations
GLP
A 6-step study-deviation workflow, with Study Director sign-off within one day and a mandatory final-report note
Contract operations
QA-agreement deviations
Hold more than one profile and you get every workflow they add, with the tightest deadline winning.
Why the record holds up
Cancelled, never deleted
A deviation raised in error is cancelled with a signed reason. It stays readable and keeps its number.
Late steps escalate, never stall
A missed deadline escalates, but the investigation stays fully workable. The late step records why.
A closure record ready to hand over
Once closed, a deviation's closure-record PDF lists every signature on it: who, when, what it meant and why.
Feature index
Everything in deviation management
Deviations
- Severity-routed workflows: a short path for minor, the full path for major and critical
- Containment required for major and critical deviations
- Root cause and root-cause category recorded at investigation
- Signed CAPA decision, signed QA approval, signed closure
- QA can return an investigation for more work
Nonconformances
- Signed disposition: reject, rework, use as is or return
- Technical rationale required for use as is
- Signed QA approval with the CAPA decision
Added by regulatory profiles
- GMP: batch deviation (1-day containment), environmental excursion
- GCP: protocol deviation, GLP: study deviation (6 steps)
- Contract operations: QA-agreement deviation
- MDR: UDI and serial number on nonconformances, ATMP: process nonconformance, 503A: medication-dispensing nonconformance
Controls on every record
- Anyone can report, and control applies from triage
- Linked CAPA raised in the same transaction as the signed decision
- A critical deviation prompts a risk assessment, made by a person
- Cancelled with a signed reason, never deleted
- Deadlines that escalate but never block, with delay reasons
- Configurable numbering, never reissued
- Closure-record PDF, with every download logged
Oversight
- My Work and the review queue
- Event trending by type, severity, site, product and root cause
One connected system
Connected across QMSdesk
A deviation is one of the quality events QMSdesk handles.
A "CAPA required" decision raises its CAPA, with its own change and training.
A critical deviation prompts an assessment in risk management.
Recurring causes show up in event trending.
Regulations
Regulations it's designed to support
- 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 §8.3 on nonconforming product
- 21 CFR Part 58 and OECD GLP under the GLP profile
- 21 CFR Part 11 for every signed decision
Questions buyers ask
Does a critical deviation raise 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. A critical deviation also prompts a risk assessment, which a person makes.
What's the difference between a deviation and a nonconformance in QMSdesk?
A deviation is a departure from an approved procedure or instruction, routed by severity. A nonconformance is about product that doesn't meet requirements, so it starts with a signed disposition. Both end in a signed CAPA decision.
Can we delete a deviation 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, and it stays readable.
Can we run batch deviations?
Yes, with the GMP profile. Batch deviations run on the deviation workflow with a 1-day containment deadline, alongside environmental excursions and product recalls.
Every deviation, on the path its severity calls for
Bring a deviation you closed last month, and we'll run it through QMSdesk with you.