GxP training · 21 CFR 211.25 · ISO 13485 §7.2
Training management software that shows who needs retraining when an SOP changes.
Role-based curricula, read-and-understood against controlled SOPs and competency records, with retraining assigned by your team when a revision is issued. Where you configure it, kiosk tasks are limited to trained people.
Role-based curricula tied to controlled SOPs
Read-and-understood tied to effective revision
Competency, Not Just Training
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping because inspectors keep finding operators running steps whose SOP was revised without them being retrained.
Read-and-understood is a paper signature filed in a binder, not linked to the effective revision of the SOP
New-hire curricula are a checklist in HR, not enforced against the roles the person will actually perform
The training matrix is a spreadsheet that shows who took what, not who is currently qualified for what
The auditor asks for the training record for operator X on SOP Y rev 4 as of last Tuesday and it takes two days to assemble
Training, run as one live GxP file.
Role-based curricula tied to controlled SOPs
Each role has a curriculum of required documents and courses; each controlled SOP declares the roles that must be trained on it.
Read-and-understood tied to effective revision
R&U signature is bound to a specific document revision. When the SOP is revised and released, the prior R&U expires for affected roles and new assignments open with the effective date — you can't run a batch under Rev 5 with people signed off on Rev 4.
Competency, Not Just Training
Per ISO 13485 §7.2 and ICH Q10, training is not competency. V5 supports observation-based assessments, proficiency demonstrations and periodic re-qualification for critical roles (aseptic operator, QP-designate, LAF gowning, forklift, torque application) — with an assessor signature distinct from the trainee's.
What changes the day this goes live.
- New hires cannot perform live tasks until their role pack is complete and evidenced
- Competency is a signed assessment, not a claimed status
- Inspector asks for a training record and gets it
The frameworks a training owner has to satisfy.
21 CFR 211.25 · EU GMP Ch.2
cGMP training — each person engaged in manufacturing, processing, packing or holding has education, training and experience for their function, with continuing training at frequency and manner sufficient to remain familiar with cGMP.
ISO 13485 §7.2 · ICH Q10
Determine competence, provide training, evaluate effectiveness, maintain records. ICH Q10 §3.2.1 makes training an enabler across the pharmaceutical quality system.
21 CFR Part 11 · EU Annex 11
Where training and R&U are electronic, records and e-signatures meet Part 11 / Annex 11 — unique credentials, non-repudiation, audit trail on training records, closed-system controls.
Training management software, answered.
How does V5 stop a batch from running with untrained operators?
The batch record's step assignment checks the current qualification of the operator against the SOP revision the step invokes.
How does V5 handle SOP revisions and read-and-understood?
R&U is a Part 11 e-signature bound to (document, revision, person). When a revision goes effective, all prior R&U signatures for affected roles are marked superseded; new assignments open for those roles with the effective date as the deadline. The old revision is still available for historical batch records, but no live task references it.
How does V5 evidence competency versus just training?
For roles you flag as critical, training completion alone does not qualify the person. A separate competency record — observation checklist, proficiency demonstration, spike test, gowning qualification — is signed by a designated assessor (not the trainee), with periodic re-qualification cycles. The qualification status the batch record checks against is the competency record, not the R&U.
How does V5 fit an integrated training programme across sites and roles?
Roles are defined at the enterprise level with site overlays for local requirements. A person can hold multiple roles across sites, each with its own curriculum and qualification status. Enterprise curricula (cGMP fundamentals, data integrity, aseptic technique, safety) roll out once; site-specific SOPs attach to site-local roles — no duplicate matrices, no divergent training histories.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.