Quality & compliance
Quality Management System
One system for documents, incidents, CAPA, audits, risks and indicators, tailored to the standards you work to.
Overview
Why quality management (QMS) on Fingress
Quality and compliance teams juggle SOPs in shared folders, incidents in spreadsheets and audit evidence in email. The Fingress Quality Management System brings them into one governed workflow. It is built from Fingress building blocks, so you can tailor it to ISO 9001, ISO 13485, ISO 15189, ISO 27001, your regulator’s framework or your own internal standards.
Who uses it
- Quality and compliance heads
- Process owners and department heads
- Internal auditors and risk managers
- Every employee who reports, reads or acts on quality records
Capabilities
What Quality Management System includes
Document control
Policies, SOPs, forms and work instructions with versioning, approval workflows, periodic review and read-and-acknowledge.
Incidents and non-conformances
Report from any device, classify, investigate and escalate, with SLAs and notifications.
CAPA
Root cause analysis, corrective and preventive actions, owners, due dates and effectiveness checks.
Audits and inspections
Plan internal audits, run checklists on tablets, record findings and follow them to closure.
Risk register
Identify, score and treat risks, and link them to controls, incidents and actions.
Indicators and management review
Quality KPIs, trends and dashboards, with management review meetings, minutes and decisions.
Functional
The complete quality cycle, in one place
Plan, do, check and act on one platform, with every record linked: a finding leads to a CAPA, the CAPA updates a document, the document change is acknowledged by staff.
Standards and requirements library
Load any standard as chapters, clauses and requirements, and map each one to your documents, controls and evidence.
Compliance readiness
Self-assessments against each requirement, gap tracking and readiness dashboards by department and clause.
Training and competency
Link training to procedures and roles, record attendance and assessments, and flag gaps when documents change.
Committees and meetings
Agendas, minutes, decisions and action items for quality and other governance committees.
Feedback and complaints
Capture customer or stakeholder feedback and complaints, and route them into investigation and CAPA.
Equipment, facility and supplier checks
Scheduled checks, calibration and maintenance records, and supplier evaluations, with reminders and escalation.
Tailor to any standard
Built from building blocks, shaped to your framework
No two quality frameworks are the same. Because the QMS is assembled from Fingress building blocks, you change it by configuration, and extend it in code only where you need to.
Your forms and fields
Configure incident, audit and CAPA forms, classifications and scoring for your context.
Your workflows
Design review, approval and escalation flows per record type, with maker-checker where required.
Your standards
Add standards and regulatory frameworks side by side, and reuse evidence across them where requirements overlap.
Your indicators
Define KPIs, formulas, targets and thresholds, and build dashboards without code.
Integration & security
Connected, controlled and auditable
The QMS draws data from the systems where work happens, and applies the same controls as every Fingress application.
Integration with business systems
Pull data for indicators and incidents from operational, HR and ERP systems through APIs, files and queues.
Governed documents with ARCIS
Store controlled documents and evidence in ARCIS, with versioning, retention and legal hold.
Roles and confidentiality
Role-based access to records, with restricted visibility for sensitive incidents and investigations.
Audit trail
Every change, approval and acknowledgement recorded with who, what and when.
Editions
Specialised editions of Quality Management System
Pre-configured for a specific line of business, on the same building blocks.
Powered by the Fingress platform
Configure it to fit, extend it when you need to
Every Fingress solution runs on the same digital platform and building blocks, so you are never limited to what ships out of the box.
Industries
Where this solution is used
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Explore solutionSee Quality Management System in action
Book a walkthrough tailored to your products, customer segments and systems.