---
title: "GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software"
description: "Learn how QbD Group helped a biotech CDMO close CAPAs across Quality Assurance, Qualification & Validation, and Software, strengthening GMP compliance and audit readiness."
url: https://qbdgroup.com/en/case-studies/gmp-support-for-closing-capas-across-qa-qualval-and-software
type: "Case study"
language: en
published: 2026-02-03
publisher: "QbD Group"
citation: "QbD Group, \"GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software\", https://qbdgroup.com/en/case-studies/gmp-support-for-closing-capas-across-qa-qualval-and-software"
---
# GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software
> Learn how QbD Group helped a biotech CDMO close CAPAs across Quality Assurance, Qualification & Validation, and Software, strengthening GMP compliance and audit readiness.

QbD Group supported a biotech CDMO in strengthening its **GMP compliance** by successfully closing all planned CAPAs across **Quality Assurance**, **Qualification & Validation**,and **Software**. This hands-on, risk-based support ensured sustainable improvements in processes, documentation, and regulatory readiness, helping the client reduce risk and enhance overall operational quality.

## Challenge

The client needed to effectively close several open **CAPAs** stemming from internal audits and regulatory requirements, within a **highly demanding GMP environment**.

The main challenge was implementing **robust and sustainable solutions** across Quality Assurance, Qualification & Validation, and Software, within tight deadlines, while minimizing **regulatory risk** and meeting the expectations of **health authorities**.

## Approach

QbD Group provided **end-to-end GMP support**, working closely with the client’s teams across **QA, Qualification & Validation, and Software**.

The approach included:

- Developing **master documents** and **SOPs** from scratch, and improving existing SOPs

- Optimizing key **processes** and addressing **audit-related deviations** using **risk-based tools**

- Ensuring continuous **follow-up** until final CAPA closure, guaranteeing **long-term sustainability**

This **practical, collaborative approach** ensured full compliance and measurable improvements in the client’s GMP systems.

## Result

The project achieved **100% closure of planned CAPAs**, with all corrective and preventive actions meeting GMP requirements and regulatory expectations.

As a result, the client significantly reduced regulatory risk, strengthened quality, validation, and software systems, and improved audit and inspection readiness.

> QbD Group’s support was instrumental in effectively closing our CAPAs and strengthening our GMP systems. Their **hands-on, risk-based approach** enabled us to implement sustainable solutions and significantly improve our **regulatory readiness**.
#### GMP Quality Auditor at Biotech CDMO
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Source: https://qbdgroup.com/en/case-studies/gmp-support-for-closing-capas-across-qa-qualval-and-software — © QbD Group. Quote freely with attribution and a link back.