Quality Management System Solution

Purpose-built to ensure FDA compliance and integrate seamlessly with your manufacturing systems, our eQMS is a 4th generation Quality Business Process Management (QPBM) solution built on an intelligent Business Process Management (iBPM) platform providing you the capabilities to managing all your quality systems and automate many of your manual or disparate electronic processes.

  • Used by over 2,200 customers worldwide in 20 different languages;
  • Product includes over 40 pre-built configurable components;
  • Only QMS solution on the market with 5 quality tools (MSA, SPC, FMEA, PPAP, and APQP);
  • Perform root cause analysis with built in RCA tools (Ishikawa Fishbone Diagram (IFD), 5 Whys, Fault Tree Analysis (FTA), and others);
  • Graphical drag & drop iBPM tool for modeling, execution, control, and monitoring of multiple business processes on a single platform;
  • New processes are automated by your in-house staff in weeks rather than months;
  • Automate batch record and annual product review processes using drag and drop technology;
  • Easy to use analytics and performance tools for customizing dashboards;
  • Compliant with FDA 21 CFR Part 11, EU GMP Annex 11, WHO Annex 5, and GDPR.

“Azimuth Compliance Consulting, in partnership with SoftExpert, will help us accelerate our movement away from our current QMS solution with its’ form-based interface, to an updated solution that is process-based and allows for the customization of workflows.”


Adam Pinkert, Vice President of Quality and Regulatory Affairs, ADMA Biologics.

ADMA Biologics

SE Suite for Life Science

Document Control

  • Document Control
  • Controlled Copy
  • Capture
  • Archive (Vault &  Record Retention)
  • Request

Risk Management

  • Risk
  • Action Plan
  • FMEA
  • Performance

Talent Management

  • Learning Management
  • Competence
  • Survey
  • Performance
  • Action Plan

Quality Management

  • Action Plan
  • Audit
  • Problem
  • CAPA
  • Change Control
  • Complaints
  • Root Cause Analysis (RCA)

Process Management

  • Form
  • Work Flow
  • Analytics
  • Process
  • BPMN Compliant
  • Process Simulation
  • Version Control

Asset Management

  • Asset
  • Calibration
  • Maintenance
  • Request
  • Time Control

Design Control

  • MCAD Connector
  • APQP / PPAP
  • FMEA
  • PDM
  • Requirements

Supplier Management

  • Supply
  • Change Control
  • Onboarding
  • Approval Vendor List (AVL) Maintenance
  • Problem
  • SCAR
  • NCP

Inspection

  • Calibration
  • Inspection
  • MSA
  • SPC
  • Request
  • Laboratory Investigation (OOS/OOT/OOE)

eBR / eDHR

  • Process Management
  • PDM
  • Requirements

EHS

  • Audit
  • Process Management
  • Risk Management
  • Waste
  • Incident

Quality Tools

  • APQP / PPAP
  • FMEA
  • MSA
  • SPC
  • Analytics
  • Performance

Put your data into action.

Bring iBPM to your business!