Part 3: GAMP 5 (Good Automated Manufacturing Practice)

Building compliant, risk-based governance for computerized systems in Pharma

As pharmaceutical companies continue to modernize manufacturing, quality, and clinical operations, computerized systems play a central role in GxP compliance. From ERP and MES to LIMS, QMS, and cloud platforms, governance around these systems must be structured, defensible, and inspection-ready.

This is where GAMP 5 (Good Automated Manufacturing Practice) becomes critical.

What is GAMP 5?

GAMP 5 is an industry-recognized framework developed by ISPE to guide the validation and control of computerized systems used in GxP-regulated environments. It provides a practical, risk-based approach to ensure systems are fit for intended use and comply with regulatory expectations.

Rather than prescribing rigid rules, GAMP 5 focuses on applying the right level of control based on system risk, complexity, and impact on patient safety and product quality.

Why GAMP 5 is important for Pharma companies

1. Risk-based system validation

GAMP 5 promotes validating systems based on their criticality and impact. This helps organizations avoid over-validation while still meeting regulatory expectations. High-risk systems receive deeper scrutiny, while low-risk systems follow streamlined controls.

This approach reduces validation effort, cost, and timelines without compromising compliance.

2. Clear system classification and ownership

GAMP 5 introduces system categories that help organizations define validation scope, supplier involvement, and documentation depth. It also emphasizes clear roles and responsibilities between business, quality, IT, and vendors.

This clarity is essential for managing complex application landscapes and global deployments.

3. Strong alignment with regulatory expectations

Regulators such as FDA and EMA consistently reference GAMP principles during inspections. While GAMP 5 itself is not a regulation, it is widely accepted as an industry best practice for demonstrating control over computerized systems.

A well-implemented GAMP 5 governance model strengthens inspection confidence and audit outcomes.

4. Enabler for digital transformation

Pharma organizations are increasingly adopting cloud platforms, SaaS solutions, AI-enabled tools, and low-code technologies. GAMP 5 supports these initiatives by providing a scalable governance model that aligns with modern delivery approaches, including Agile and DevOps.

It allows innovation without losing compliance control.

5. Foundation for Computer System Assurance (CSA)

GAMP 5 complements the FDA’s CSA guidance by shifting focus from excessive documentation to critical thinking, testing of intended use, and assurance of patient safety and data integrity.

Together, GAMP 5 and CSA form the backbone of modern validation governance.

Common challenges without GAMP 5 governance

• Inconsistent validation approaches across systems and sites

• Over-documentation with limited compliance value

• Poor visibility into system risk and control gaps

• Delays in system go-live due to unclear validation strategy

• Increased regulatory observations during audits

These challenges often arise when validation is treated as a one-time activity rather than an ongoing governance process.

How REDE Consulting helps Pharma companies with GAMP 5

REDE Consulting works with pharmaceutical organizations to design and implement practical, inspection-ready GAMP 5 governance models aligned to their business and regulatory landscape.

We help clients with:

• GAMP 5–based validation strategy and governance frameworks

• System classification, risk assessment, and intended use definition

• Integration of GAMP 5 with CSA principles

• Validation of ERP, MES, LIMS, QMS, and cloud platforms

• Embedding GAMP governance into ServiceNow IRM and GRC workflows

• Audit readiness and regulatory inspection support

Our focus is on simplifying compliance, reducing validation burden, and enabling digital transformation without increasing regulatory risk.

Looking to modernize your validation approach?

If your organization is struggling with legacy validation practices, expanding digital platforms, or preparing for regulatory inspections, REDE Consulting can help you implement a right-sized GAMP 5 governance model that works in the real world.

Contact REDE Consulting ( info@rede-consulting.com ) to learn how we support Pharma companies in building scalable, risk-based, and future-ready compliance programs.