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QAbility

QUALITY MANAGEMENT, REIMAGINED

Quality, Simplified.

A smarter way to manage quality workflows.

Bring quality processes, tasks, and documentation together in one connected system. Make quality easier to manage as your business grows.

QAbility QMS at the top, connected to Documents, Quality issues, Operations, Supply chain and Oversight, each with its modules below

Everything in one system

Every capability, one login, one record of truth.

Connected, end to end

Every record knows where it came from.

A problem found anywhere travels to the fix, the change and the retraining, with its evidence and its links.

Document Control

Templates, Workflows, Approvals and Training, without the paperwork.

  1. Ready-to-Use Templates

    Create standardized documents using reusable templates.

    - Create standardized document templates. - Build reusable formats for SOPs, policies, and work instructions. - Customize document layouts to fit your processes. - Maintain consistency across quality documentation. - Simplify document creation with predefined structures.

    Creating a new controlled document from a template in QAbility
  2. Custom Easy Workflow Builder

    Build workflows for document review, approval, and release.

    - Easy to build workflows tailored to your approval processes. - Assign reviewers and approvers to each step. - Define sequential or parallel approval paths. - Track workflow progress and pending actions. - Streamline document review, approval, and release.

    The workflow template builder with review and approval steps
  3. Approve with e-signatures

    Approvers sign with a signature PIN, one or all of them, and the version goes effective.

    Signature PIN re-checks identity • Meaning recorded • Reject or request info • Effective on approval

    A workflow in progress, with a completed step and the next approval waiting for its approver
  4. Integrated Training & Quizzes

    Assign training automatically on effective versions, evaluate trainees and connect document updates with employee training requirements.

    - Assign training by role. - Verify knowledge through assessments. - Track quiz results and training completion. - Maintain training records for audit readiness. - Assign training to relevant employees or user groups. - Trigger training when revised documents require acknowledgment. - Maintain records of training completion and acknowledgment.

    Quiz questions on a training assignment linked to a controlled document

Non-Conformance: Find The Root Cause, Not Just The Symptom.

Raise it, contain it, investigate it and dispose of it in one record, with the tools to find out why it happened.

Raise it from anywhere

From a QC lot, an audit finding, a complaint, a quality event or a supplier.

Assign tasks

Assign one or multiple tasks to any team member.

Link records

Link relevant QMS documents to the nonconformance record.

Root cause tools built in

Fishbone, 5-Why, Is/Is-Not and why-tree analyses on the record.

Your workflow, e-signed

Review and approval steps you configure, closed with an e-signature.

CAPA created and linked

Mark it CAPA required and the CAPA opens, linked to this NC.

A closed nonconformance
A closed nonconformance with its severity, root cause, disposition and cost
Root cause templates
Root cause analysis templates: fishbone, 5-Why and Is/Is-Not

CAPA: From Root Cause To Proven Fix.

A closed CAPA
A closed CAPA with its source and effectiveness details
The CAPA workflow
The CAPA workflow with its approval steps

Each CAPA carries its source, its root cause, its actions and its proof that the fix worked.

Linked to its source

The nonconformance, complaint or audit finding it came from, one click away.

Root cause analysis

Fishbone, 5-Why and Is/Is-Not, turned into a clear root-cause statement.

Corrective and preventive actions

Add actions as the work unfolds, each with its owner and due date.

Approvals your way

Steps that need any one, or all, of their approvers, each with an SLA.

Effectiveness checks

A scheduled check, with reminders, before the CAPA can close.

Linked change requests

Raise the change request for the fix straight from the CAPA.

E-signed closure

Closed with a signature that records who signed and what it meant.

QC Inspection: Inspect Components, In-Process and Outbound.

Every lot is inspected against its approved specification and sampling plan, at the point where it happens.

Every inspection point

Incoming components, in-process checks, outgoing shipments and final release.

AQL sampling built in

ANSI/ASQ Z1.4 and ISO 2859-1 tables pick the sample size for each lot.

Versioned specifications

Each item inspected against its current approved specification.

Results per characteristic

Record each measurement and check against its limits.

Calibrated instruments only

The instrument’s calibration due date is checked before a result counts.

E-signed disposition

Accept or reject each lot with a signature, plus retain samples and line clearance.

Straight to NC and CAPA

A rejected lot opens a pre-filled nonconformance, and from there a CAPA.

An inspection lot and its results
An inspection lot with its sampling plan, results per characteristic and disposition
Versioned specifications
The specifications library with versioned item specifications

Suppliers Management: Share Exactly What Each Supplier Needs.

The supplier record
A supplier record with its risk profile, audit findings and contacts
The supplier portal
The supplier portal showing the document requests a supplier has to answer

Each supplier or contract manufacturer gets a portal that shows only what you share with them.

One record per supplier

Profile, contacts, locations, risk level and status in one place.

A portal of their own

Suppliers and contract manufacturers sign in and see only what you share.

Document requests

Ask for certificates, specifications and records; they answer in the portal.

Expiry alerts

Know before a supplier certificate lapses.

Share any record, safely

A read-only link opened with a one-time code: revocable, and every view logged.

Supplier NCs and CAPAs

Send a supplier-caused nonconformance, or a CAPA step, for the supplier to answer.

Weighted evaluations

Score suppliers on your own criteria and rating bands.

Supplier audits

Plan supplier audits in the same audit programs.

Business Analytics: See Quality Metrics

Dashboards and reports built from the records themselves, so the numbers are never re-keyed.

Quality dashboards

Open NCs, CAPA aging, audit findings and training status at a glance.

Your own metrics

Build metrics with a live preview, on any module, custom ones included.

Automatic insights

Anomalies, streaks and change points flagged on your metrics.

Forecasts

See when a trend will cross its threshold.

Scheduled reports

Excel or PDF reports delivered by email on your schedule.

A quality dashboard
A quality analytics dashboard with charts of audit findings
Metric alerts
Threshold alerts set on quality metrics

A Smarter Way to Manage Audits

An audit and its findings
An audit with its findings, evidence and status
A standard, clause by clause
An audit standard with its clauses and requirements

Plan, run and close internal, external and supplier audits against the standards you work to.

Audit programs

Recurring internal, external and supplier audits on one calendar.

Standards library

ISO 9001, ISO 13485 and your other standards, clause by clause, versioned.

Clause-based audits

Map audit questions directly to applicable standards and clauses.

Dictate findings by voice

Speak a finding during the walkthrough; it is written into the record.

Share audit agendas

Create and share audit agendas directly through the portal.

Audit readiness

Keep audit plans, evidence, findings, and actions organized in one system.

Digital Logbooks: Retire The Printed Logs.

The log sheets your document control prints for the floor become electronic log books, always the current approved version.

QR labels for every space

Print a label for each line, room or instrument; a scan opens the right log.

Any phone, no app

Operators file from a mobile page in the phone’s browser.

Over-the-shoulder sign-off

The supervisor signs at the operator’s screen with their own PIN.

Entries that stay put

Entries lock when their edit window closes; a void needs a reason and a signature.

Only trained people file

Filing is checked against training on the linked SOP.

Equipment kept current

Calibration and PM entries roll the instrument’s due dates forward.

The logs register
The logs register with entries, their class, status and lock state
Log books
The list of log books with their class, supervisor and edit window

Why QAbility

Easier To Use, Faster Go Live

Typical eQMSQAbility
Go-liveMonths of implementation
ValidationTest scripts written for you, at extra cost
PricingPer seat, with modules sold separately
Connected recordsSeparate modules, re-keyed data
Shop floorPrinted forms, or a separate tool
ChangeA consultant for every workflow change

“Typical eQMS” describes common market practice, not a named product.

  • WeeksFrom kickoff to live, not months
  • Unlimited UsersFor shop-floor, training and supplier access
  • All-inEvery capability in every plan
  • IncludedValidation test scripts, and a sandbox to run them

See your own process running in QAbility. In weeks, not months.

  • Thirty minutes, on your process
  • Your records, not a canned tour
  • Straight answers on what it does and doesn’t do