Quality Systems

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 Introduction

A Quality System in an analytical laboratory ensures that all scientific data generated is credible, reproducible, and in line with regulatory expectations. Just as GLP (Good Laboratory Practice) forms the foundation of non-clinical research, a robust quality system guarantees operational integrity, especially in Contract Research Organizations (CROs) where precision and compliance are non-negotiable.

What is a Quality System?

A Quality System is an integrated framework of policies, processes, SOPs, and controls designed to meet regulatory standards such as GLP, GMP, ISO 17025, and ICH guidelines. It governs how work is planned, performed, documented, and reviewed to ensure reliability and traceability of data.

Key elements include:

  • Document Control

  • Change Management

  • Deviation and CAPA Management

  • Internal Audits

  • Training Records

  • Data Integrity Measures

  • Archival and Record Retention

Quality Systems in CRO Labs

In CROs, particularly those supporting toxicology, pharmacokinetics, and analytical method validation, the role of a Quality System is to:

  • Ensure that every step from sample receipt to final report is traceable.

  • Comply with OECD GLP, US FDA, EMA, and MoEFCC- Ministry of Environment, Forest and Climate Change guidelines.

  • Facilitate successful regulatory audits and sponsor confidence.

  • Manage instrument qualification (IQ/OQ/PQ), method validation, and analyst competency.

Why is it Critical for Emerging Professionals?

For students and early-career scientists entering the pharma, biotech, or agrochemical industries, understanding quality systems:

  • Builds discipline and accountability.

  • Enhances job readiness in regulated environments.

  • Prepares them to contribute to regulatory submissions and global audits.

Visnova’s Edge

At Visnova Consultancy, we train and mentor emerging pharma professionals to go beyond routine lab work by:

  • Simulating GLP audit scenarios

  • Building SOP libraries

  • Mapping analytical workflows

  • Integrating digital compliance systems

Our goal is to nurture talent that can bridge academia and CROs with a strong foundation in Quality Culture.

A quality system is not just about compliance—it’s about scientific integrity. In the world of GLP and CROs, it’s the compass that guides labs toward credibility, efficiency, and global readiness.

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