QMS software for manufacturing
Quality records that start where the problem happened: on the line.
V5 keeps deviations, corrective actions, controlled documents and training on the same platform as your batches and equipment. Your procedures decide the approval route, and people sign every decision.
Raised with context
Deviations carry the batch, step and equipment involved.
Linked records
CAPA, documents, training and suppliers on one platform.
People sign
Your procedures set approvals; people sign each decision.
- V5 records
- The step, batch, equipment and operator are attached when it is raised.
- Your team decides
- Classification and whether to investigate.
Approval routes follow your procedures and role permissions.
Is V5's QMS a fit?
- Good fit: manufacturers whose deviations, CAPA and training sit apart from production records.
- Bring: one recent deviation, the SOP it touched and the training records involved.
- Check in scoping: your approval routes, document migration and which modules your plan includes.
- Plan for: your own validation; IQ/OQ support is offered on Enterprise plans.
Free buyer guide · 12 pages · PDF
Quality Management Buyer Guide
For quality, regulatory and operations teams choosing quality management software. Use it with or without V5.
Get the guide on the quality pageFull product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
Signs your quality system sits too far from the floor
Deviations are retyped from paper into a separate system
Investigators chase the batch, equipment and operator details by email
Training records do not show who was qualified on the day
Supplier status lives in a spreadsheet nobody trusts
What V5's quality management covers today
Deviations and CAPA
Support deviations, corrective actions and quality review with the batch, step and equipment attached.
Controlled documents
Controlled-document workflows with revisions, electronic signatures and audit history.
Training and qualification
Personnel qualification connected to operational records and kiosk permissions you configure.
Supplier qualification
Supplier records and qualification kept beside receiving and quality records.
Complaints
Customer complaint intake and investigation linked to the lots involved.
Management review
Reports and dashboards bring quality and operational information into review.
Before you choose: fit and implementation
- Start with one process, such as deviations, and connect documents and training next.
- Your procedures and role permissions determine the approval workflow; V5 records it.
- Bring a recent deviation or audit finding to the trial and walk it through end to end.
- Certification and your validation status depend on your quality system, not on software features alone.
- IQ/OQ support is offered on Enterprise plans; performance qualification stays with your team.
QMS software for manufacturing: buyer questions
What makes a QMS suitable for a manufacturing plant?
The quality record needs the production context: which batch, step, equipment and people were involved. In V5, quality management runs on the same platform as batch execution and equipment, so investigators start from that record instead of rebuilding it.
Who approves a CAPA or closes a deviation?
People do. Your procedures and role permissions set who reviews, approves and closes. V5 records each decision with an electronic signature and audit history.
Does V5 support the FDA QMSR and ISO 13485?
V5 provides controlled documents, CAPA, training and audit records that device manufacturers use under the QMSR, in effect since 2 Feb 2026, which incorporates ISO 13485:2016. Conformance depends on your quality system and procedures.
Can we use V5 for quality only, without the MES?
Quality workflows can be used on their own. Which modules your plan includes is shown on the pricing page or confirmed with our team.
Does AI write our investigations?
AI can draft CAPA and deviation text from linked records for a person to edit, approve and sign. It does not classify, approve or close records. See the AI governance page.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Walk one of your deviations through V5.
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