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Pharmaceuticals

How a Pharmaceutical Company Achieved ISO 9001 Certification in 3 Months Using QMS Software

Case study: From compliance chaos to auditable processes

PRODUCT

ProQMS - Advanced Quality Management System

TEAM SIZE

4 people

DEPLOYMENT TIME

12 weeks

The Challenge

A pharmaceutical manufacturer struggled with ISO 9001 compliance, managing audit trails via email and paper. Audits revealed 47 non-conformances.

The Solution

Implemented ProQMS with automated audit scheduling, CAPA tracking, document control, and real-time compliance dashboards.

Key Results

✓

Achieved ISO 9001 certification in 90 days

✓

Non-conformances reduced from 47 to 2 in audit

✓

Audit preparation time decreased from 3 weeks to 3 days

✓

Training management became automated

✓

Compliance documentation 100% digitized

Related Keywords

ISO 9001 compliance software pharmaceutical QMS quality management system pharma ISO certification software CAPA management quality management system pharma quality software ISO audit management quality assurance software regulatory compliance software proqms pharmaceutical quality software CAPA tracking software

Implementation Details

DEPLOYMENT TIME

12 weeks

TEAM SIZE

4

team members

PUBLISHED

Jan 2026

Client Testimonial

"ProQMS was instrumental in our ISO certification journey. The automated audit scheduling and CAPA tracking saved our quality team countless hours. What previously took months of preparation for audits now takes days. Exports to new markets are now possible thanks to certified compliance."

Published

Jan 25, 2026

Industry

Pharmaceuticals

By

MLGLOBTECH Case Study Team