Minimize paper. Maximize quality.

Life science organizations face rising regulatory demands and increasing operational complexity. Smart-QMS replaces binders, spreadsheets, and paper forms with connected digital workflows that accelerate quality work, reduce errors, and strengthen compliance.

Always the right version

Controlled documents reach the right people, with approval routing and read and sign training built in.

Every event traced to closure

Deviations, complaints, and changes move through defined workflows, with CAPAs launched at the point of need.

Inspection-ready every day

21 CFR Part 11 e-signatures and complete audit trails mean there is nothing to reconstruct before an audit.
SOP-CP-014, revision 7
Cryopreservation of HPC products
In approval
  1. Author routed for approvalL. Chen, Cell Processing
    Signed
  2. Quality reviewM. Ortiz, Quality Assurance
    Approved
  3. Medical director approvalApproval Wizard, change summary attached
    Awaiting
Differences PDF: 6 changes highlighted against revision 6
On release, read and sign training is assigned to 42 staff in Cell Processing

Illustrative example

Quality control and compliance capabilities

Every part of your quality system on one platform, configured to the way your organization works.

Document control

Ensure every team works from the correct approved version throughout first draft, release, periodic review, and obsolescence.

Training and competency

Keep staff qualified with automated training, read-and-sign tasks, quizzes, and competency assessments tied to each role.

Deviations and CAPA

Capture planned and unplanned deviations. Escalate them and prevent repeat problems through structured CAPA workflows.

Complaints management

Resolve complaints quickly with electronic intake, standardized forms, and full traceability to resolution.

Change control

Prevent uncontrolled changes by tracking impact and approvals, and by managing the training updates each change requires.

Audits and accreditation

Plan, run, and report internal and external audits. Stay ready for CAP, FACT, CLIA, and 21 CFR Part 11 requirements.

Error management

Manage incidents, deviations, and non-conformances electronically to improve patient safety and lower compliance risk.

Macro configuration

Automate form behavior and enforce validations so forms fill and check themselves, eliminating manual steps.

Trend alerts

Detect quality issues early with configurable rules, notifications, and guided follow-up actions.

Documents and training, connected

When a controlled document changes, the training that depends on it follows automatically.

Document control

Manage every revision-controlled document from creation through revision, collaboration, approval, release, and obsolescence.
  • Approval routing with signature routes, change summaries, and 21 CFR Part 11 e-signatures
  • A differences PDF that highlights every change in red, with the record of approvals appended
  • Scheduled periodic reviews with required comments and a full review history
  • Packages that approve, release, or obsolete related documents together for a change control
  • Controlled printing with watermarks, plus a nightly document export for downtime access

Learning management

A built-in learning management system keeps curricula, retraining, and training history current for every employee.
  • Plans, courses, quizzes, and recurring schedules that keep training current
  • Read and sign on controlled documents, with multimedia opened before sign-off
  • Competency assessments with pre-assessment, assessor sign-off, remedial, and final approval
  • Classroom rosters and attendance sign-off for trainers, plus SCORM course support
  • Training rechecked automatically when an employee changes department or job code

Catch quality trends before they become findings

Trend alert rules watch your quality events and raise an alert when a pattern appears, such as repeated events with the same code in a short window.

Rules built on your data

Start from a saved search, link the rule to event codes, and set its priority.

Run when it matters

Rules run when an event is created or closed, or on a schedule, and notify the right group in the system or by email.

Act from the alert

Acknowledge with a defined action, or open a CAPA straight from the alert, already linked to the events behind it.
Trend alert TA-0187
Raised when an event closed, high priority
Open
Rule3 or more labeling deviations within 30 days
  • DEV-2026-0412Sep 18
  • DEV-2026-0431Oct 2
  • DEV-2026-0447Oct 14
Create CAPAAcknowledge
Every rule run, acknowledgement, and action is recorded in the audit log

Illustrative example

The success factor for ImpactLife was maximizing the benefits on an electronic system.

Director of Regulatory Compliance
ImpactLife

82%

Fewer hard copy manuals

208 days

Of staff time saved each year managing manuals

19 hrs

Less time spent on version control each week

13 hrs

Of staff time returned to operations each week

Source: ImpactLife document control case study.

Reliable, audit-ready operations

Built to meet the standards cellular therapy, blood, and laboratory programs are inspected against, with a validation package ready for your inspectors.

Stronger compliance

Digital workflows and complete audit trails across every quality record.

Less manual work

Document control, training, and CAPA run without binders or spreadsheets.

Ready teams

Structured, role-based training keeps every employee qualified for the work they do.

Full visibility

See every quality event, task, and risk in one place, with personalized dashboards.

Multi-site scale

Run one quality system across sites, with shared standards and local control.

A stronger foundation

Consistent, inspection-ready operations that support safe products and patient care.
21 CFR Part 11CAPCLIAFACT-JACIEAABBISBT 128HIPAA

Solutions Overview

Smart-QMS at a glance

Download our two-page guide to Smart-QMS capabilities, compliance features, and how it supports every part of your quality system.

Complete the form to download.

See Smart-QMS run your quality system.

Bring an SOP, a deviation, or an upcoming audit.
We will show you how it moves through Smart-QMS, from draft to closure.

Schedule a demo
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