PlatformTraining and competency
Training management software for life sciences teams
QMSdesk™ is training management software for life sciences that assigns the right training the moment something changes. Every completion is proven and signed, so you always know who is trained on what.
SOP-014 v3
Cleaning of filling line 2
Workflow
Step 2 of 4: Completed
- Assigned
- On document approval
- Completed by
- Signed acknowledgment or quiz
- Overdue for a GxP-critical role
- Opens a risk
What changes for your team
01
Training that starts itself
An SOP is approved, a change is implemented, someone joins or changes role. QMSdesk assigns the training, with a due date, without anyone building a spreadsheet.
02
Evidence that says exactly what happened
Each way of completing training produces its own signed evidence. A read-and-understood signature, an auto-graded quiz, an assessor's sign-off or an accepted certificate each say what they are.
03
Gaps you hear about early
Overdue training escalates up a reminder ladder. When the overdue training belongs to a GxP-critical role, QMSdesk opens a risk item, so it reaches your risk register before it reaches an inspector.
GxP training software that follows your quality system
On Monday your Quality Manager approves a revised cleaning SOP. Here is what happens next.
Step 1 of 4
Assigned
Training goes to everyone in the affected roles the moment the SOP is approved. The document takes effect after a grace period, 14 days by default, so people have time to train first.
Step 2 of 4
Completed
Each person reads the SOP and signs "I have read and understood this document". It appears in their My Work list.
Step 3 of 4
Followed up
Anyone who hasn't finished gets reminders that escalate from the owner to the coordinator to the Quality Manager.
Step 4 of 4
Escalated to risk
If the overdue training belongs to a GxP-critical role, a risk item opens on its own.
The same thing happens when a change is implemented, when a CAPA action plan is approved, and when someone joins, changes role or moves department. Recurring refreshers are reassigned on schedule.
Training management software highlights
Four ways to complete, each signed for what it is
- Acknowledgment: a signed "read and understood".
- Quiz: auto-graded against a snapshot frozen when the training was assigned. Editing the question bank later never changes an existing assignment.
- Practical assessment: signed by a qualified assessor.
- External certificate: accepted, never "approved", because your organization didn't produce it.
Competency assessments by qualified assessors
Record that a named person demonstrated competence in a subject, at a level, on a date. The assessor must be qualified for that subject, and nobody can assess themselves.
Waivers and equivalencies that expire
When a requirement doesn't apply to someone for a while, a Quality Manager signs a time-limited waiver. When prior training or an outside qualification covers it, an approver signs an equivalency. Both are recorded, never silent.
Training status across your organization, one click away
Training Intelligence, a rule-based status view in the Command Center, shows where training stands across your organization. Each person's transcript shows everything they've completed, and restricted documents stay hidden from anyone without the right to see them.
Feature index
Everything in training management
Assignment
- Automatic assignment on document approval
- Automatic assignment on change implementation and CAPA action-plan review
- Automatic assignment on new hire, role change and department change
- Recurring refreshers, reassigned on schedule
- Assignment on approval, ahead of a default 14-day effective-date grace period
Completion and evidence
- Signed acknowledgment ("I have read and understood this document")
- Auto-graded quizzes against a frozen snapshot
- Practical assessments signed by a qualified assessor
- External certificates, accepted rather than approved
- Competency assessments by qualified assessors
- Signed, time-limited waivers
- Signed equivalencies for prior training or outside qualifications
Follow-up and oversight
- Overdue flags, daily digests and an escalating reminder ladder
- A risk item opened when training for a GxP-critical role is overdue
- Training transcripts per person, with restricted documents hidden
- The Training Intelligence view in the Command Center
- Training tasks in each person's My Work list
- REST API access to training assignments
Records
- Re-authentication at every signature, with a controlled vocabulary of signature meanings
- A hash-chained, insert-only audit trail on every action
One connected system
Connected across QMSdesk
Document control assigns training the moment an SOP is approved.
Change control and CAPA raise the training their actions require.
Risk management receives a risk when GxP-critical training lapses.
Reporting and analytics shows training status in the Command Center.
Regulations
Regulations it's designed to support
- 21 CFR 211.25. Controls for documenting that personnel are trained for the work they do, under the GMP profile.
- ISO 13485. QMSdesk is built to support organizations working to ISO 13485:2016, including competence and training records (§6.2).
- FDA QMSR. It incorporates ISO 13485:2016 by reference.
- 21 CFR Part 11. Training completions use controls for Part 11 electronic signatures.
Questions buyers ask
How does training get assigned?
Automatically, when a document is approved, a change is implemented, a CAPA action plan is approved, or someone joins, changes role or moves department. Recurring refreshers are reassigned on schedule.
What counts as completing training?
One of four methods: a signed acknowledgment, an auto-graded quiz, a practical assessment signed by a qualified assessor, or an accepted external certificate.
What happens when training is overdue?
Reminders escalate from the owner to the coordinator to the Quality Manager. When the training belongs to a GxP-critical role, QMSdesk also opens a risk item.
Is QMSdesk a GxP LMS?
QMSdesk manages GxP training as quality records: who must be trained on what, by when, and how completion was proven and signed. It is connected to your documents, changes and CAPAs, so training follows the quality system.
Can we waive training for someone?
Yes, with a signed, time-limited waiver from your Quality Manager. When prior training covers the requirement, you record a signed equivalency instead.
Every SOP change, trained and signed
Bring your next SOP revision. We'll show you QMSdesk assigning, tracking and proving the training.