One structured operation for QA

Batch record release, audits, inspections, investigations, and QA standards usually exist in separate trackers. Smart-QA combines them into one web-based system that improves efficiency, visibility, accountability, and compliance.

One structured operation

Batch record release, audits, inspections, investigation time, and standards in one system.

Connected to your systems

Works with SAP, Oracle, TrackWise, LIMS, and more, so teams keep the tools they already use.

Automated scheduling

A flexible, multi-factor algorithm schedules QA work and makes room for manual assignments.
QA whiteboard, first shift
Batch record review, live
Live
2.4 daysAverage release turnaround
87%Right first time
14Records in queue
  • BR-24-1187Lot 0412, fill and finish
    M. OrtizIn review
  • BR-24-1191Lot 0415, formulation
    D. ChenRight first time
  • BR-24-1192Lot 0416, formulation
    D. ChenReturned, 2 errors
  • BR-24-1196Lot 0419, packaging
    UnassignedScheduled for 2nd shift
Open items carry into the shift pass-down report automatically

Illustrative example

How it works

From connected data to a scheduled, tracked, and measured QA operation.

  1. Connect

    Pull batch record issuance from SAP or Oracle, quality event time from TrackWise, and data from LIMS.

  2. Plan and schedule

    A multi-factor algorithm schedules QA work automatically, alongside tasks your leads assign by hand.

  3. Track in real time

    An electronic whiteboard shows every batch record, audit, and investigation as the work happens.

  4. Hand off between shifts

    Shift management, pass-downs, and shift reports keep nothing from falling between teams.

  5. Report and improve

    Track KPIs and trends, find root causes, and confirm that improvements and corrective actions worked.

Capabilities for every QA activity

Plan, track, and measure the work that stands between manufacturing and release.

Batch record release

Track release with KPIs for turnaround time, right-first-time rate, and time spent per record.

Audits and inspections

Manage preparation, findings, and follow-up actions for every audit and inspection.

Investigation time management

Capture the time spent on investigations to measure your true Cost of Quality.

Multi-factor scheduling

Automated scheduling that weighs several factors and works alongside manual assignment.

QA standards management

Configurable forms and checklists that keep QA work consistent across shifts and sites.

Reports and dashboards

Efficiency, release, observation, and weekly and monthly performance reporting.

More ownership, less chasing

What changes when every QA task is planned, visible, and measured.

Manage efficiency everywhere

Track the full batch record process, audits, clearances, swabs, inspections, and time spent on SOPs, deviations, and monitoring.

See QA work in real time

An electronic whiteboard shows what every reviewer is working on, and what is waiting.

Report faster

Spend less time collecting data and building reports, and more time on review.

Improve continuously

Measure process deviations, track trends, find root causes, and confirm that fixes worked.

Results in three months

A generic drug manufacturer measured these improvements three months after implementing Smart-QA.

Par Pharmaceutical

29%

Fewer batch record errors

50%

Fewer reviews

19%

Faster response to correct manufacturing errors

3 months

From implementation to measured results

Source: Par Pharmaceutical, results reported three months after Smart-QA implementation.

Live in weeks, not months

Smart-QA is built on the Smart-QC architecture, so it can be integrated with almost any system and rolled out quickly, starting with batch record management.

  • Go live in 3 to 4 weeks, starting with the batch record management module
  • Built on the proven Smart-QC architecture
  • Hosted on Amazon cloud, with technical support after go-live
  • Implementation, integration, and post-go-live services from one team
Connected to the systems you already run
Batch issuance, quality events, and lab data
SAPOracleTrackWiseLIMSERPQMS
Work, time, and status in one place
Smart-QAOne plan for QA work and release

Solutions Overview

Smart-QA at a glance

Download our two-page guide to Smart-QA scheduling, batch record release tracking, and QA reporting.

Complete the form to download.

Shorten your batch release cycle.

Bring your current release backlog. We will show you how Smart-QA
plans, tracks, and reports QA work around it.

Schedule a demo
Contact sales