Controlled documents
Know which version is current, what is waiting for approval, and what is due for review.
eQMS for regulated manufacturers
Quality management software built around how regulated teams actually work.
TrackerQMS gives regulated manufacturers one place to manage controlled records, approvals, training, suppliers, audits, quality events, risk, compliance, and the work that connects them.
Readiness overviewQuality operating center
Audit readyApprovals18direct actions
Expiring evidence7supplier files
Training94%on-time
SOP-0042Packaging validation procedureReview queued
SUP-0188Critical supplier agreementExpires soon
AUD-0009Internal audit findingResponse due
Built for regulated quality teamsISO 13485 workflowsSupplier qualityDocument controlAudit readiness
Why TrackerQMS
Know what is current, what is due, and who owns the next step.
TrackerQMS brings the information quality teams routinely have to chase into the workflow itself. Status, ownership, due dates, evidence, and required actions stay visible as the work progresses.
Supplier evidence
See qualification status, required records, performance, risk, and upcoming expirations without assembling a separate report.
Training impact
See who is affected by a released change, what training was assigned, and what is still outstanding.
Action queues
Give each user a clear view of the approvals, reviews, training, and other work that requires action.
Connected workflows
Carry quality decisions into the processes they affect.
A change in one part of the QMS often creates work somewhere else. TrackerQMS can carry those relationships forward so training, risk, CAPA, supplier activity, and other follow-up work stay tied to the event that started them.
Changes can carry forward into training, risk, suppliers, quality events, and other affected work.
Use roles, ownership, record type, scope, and other business rules to send work to the right people.
Keep approvals, signatures, revisions, status changes, and related activity available as part of the record history.
Platform modules
Cover the core processes your quality team depends on.
Use the modules that fit your operation today, with shared workflow, security, records, and reporting across the platform.
Document Control
Author, upload, revise, approve, release, archive, review, and download controlled copies.
Learn more →Supplier Quality
Manage suppliers, evidence, criticality, qualification, scorecards, and compliance expirations.
Learn more →Training
Connect released documents to training assignments, acknowledgements, and signature evidence.
Learn more →Audits & Findings
Track audits, findings, owners, responses, closure evidence, and readiness gaps.
Learn more →TrackerQMS AI Assistants
Use AI where it can reduce routine quality work.
AI Assistants are embedded in 13 quality areas for tasks such as summarization, comparison, gap analysis, structured drafting, and record generation. AI output stays within the existing QMS workflow and remains subject to the same review and approval controls.
Manage product and quality records with the controls medical device teams need.
Support document control, training, supplier quality, audits, risk, signatures, and evidence across the product lifecycle.
View medical device solution →Manage quality requirements across customers, suppliers, and sites.
Coordinate internal quality work with supplier controls, customer requirements, audits, approvals, and corrective actions.
View contract manufacturing solution →QMS resources
Practical guidance for evaluating and improving a QMS.
Resources on document control, supplier quality, audit readiness, and other areas that commonly drive QMS decisions.
Guide
ISO 13485 Document Control
Manage controlled documents, review dates, training impact, and approval evidence.
Read guide →GuideMedical Device QMS Software
Compare the QMS workflows medical device teams need most.
Read guide →GuideSupplier Quality Management
Keep supplier status, evidence, expirations, and readiness visible.
Read guide →FAQ
Common questions about TrackerQMS
What is TrackerQMS?
TrackerQMS is quality management software for regulated manufacturers. It supports document control, training, supplier quality, audits, quality events, risk, compliance, and other core QMS processes.
Is TrackerQMS built for ISO 13485 teams?
TrackerQMS is designed around regulated manufacturing workflows such as controlled documents, approvals, training evidence, supplier quality, audit trails, and periodic reviews that support ISO 13485 quality systems.
Can TrackerQMS replace spreadsheet-based quality tracking?
Yes. TrackerQMS is designed to replace spreadsheet, shared-drive, and email-based tracking with controlled records, assigned ownership, workflow, approvals, and searchable history.
See TrackerQMS in your environment
See how TrackerQMS fits your quality system.
Review the workflows, controls, and modules that matter to your organization and see how they would work together in practice.
What to expect in a walkthrough
- Your highest-priority quality workflows
- Roles, routing, approvals, and record controls
- How TrackerQMS can fit your current process and rollout plan