What is GAMP 5 and why you need to know it | Valkit.ai
What is GAMP 5 and why you need to know it
Discover what is GAMP 5 and why it’s crucial for GxP compliance, patient safety, and efficient computerized system validation.
Steve Ferrell·
What is GAMP 5? (Quick Answer)
What is GAMP 5 is one of the most common questions in pharmaceutical and life sciences validation — and the short answer is this:
GAMP 5 (Good Automated Manufacturing Practice, 5th edition) is a guidance document published by the International Society for Pharmaceutical Engineering (ISPE) that provides a risk-based framework for validating computerized systems in GxP-regulated environments such as pharma, biotech, and medical devices.
Key facts at a glance:
Full name: Good Automated Manufacturing Practice, 5th Edition
Publisher: ISPE (International Society for Pharmaceutical Engineering)
Current version: Second Edition, published July 2022
Purpose: Ensure computerized systems are fit for intended use, compliant with regulations, and protect patient safety, product quality, and data integrity
Is it a regulation? No — it is industry guidance, but regulators like the FDA and EMA treat it as the gold standard for computer system validation (CSV)
Who uses it? QA teams, validation specialists, IT leads, and engineers in pharma, biotech, and medical device companies worldwide
If you manage computerized system validation, you've likely felt the weight of it: stacks of documentation, endless test scripts, and the constant pressure that one missed step could trigger a regulatory finding. Data integrity failures are consistently among the top reasons for FDA warning letters — which means getting validation right isn't just good practice, it's a business-critical necessity.
GAMP 5 exists to cut through that complexity. Rather than demanding you test everything, it tells you to focus your effort where it matters most — on the systems and functions that could actually harm product quality or patient safety if they failed.
The Second Edition (2022) was the most significant update in 14 years, adding guidance on Agile development, cloud computing, AI/ML systems, and blockchain — reflecting just how much the technology landscape has changed since 2008.
Steve Ferrell
Chief Product Officer
I'm Stephen Ferrell, Chief Product Officer at Valkit.ai and a contributing author to the GAMP 5 Second Edition, with over 20 years of hands-on experience guiding organizations through computerized system validation and GxP compliance — including chairing GAMP Americas and serving on the ISPE GAMP Global Steering Committee. My work has been focused on making what is GAMP 5 not just something you understand in theory, but something you can apply efficiently and defensibly in practice. In the sections below, I'll walk you through everything you need to know — from core principles to software categories to modern implementation approaches.
What is GAMP 5 and Why is it Crucial for GxP?
In the highly regulated worlds of pharmaceuticals, biotechnology, and medical devices, computerized systems run almost everything. From Enterprise Resource Planning (ERP) platforms managing supply chains to Laboratory Information Management Systems (LIMS) tracking clinical samples, software is the invisible backbone of modern medicine.
But with great automation comes great responsibility. If a piece of software calculates a drug dosage incorrectly or fails to record an audit trail, the consequences can be catastrophic. This is where GxP compliance (Good Practice guidelines, including Good Manufacturing Practice [GMP], Good Laboratory Practice [GLP], and Good Clinical Practice [GCP]) comes into play.
The core mission of GxP is simple: protect patient safety, product quality, and data integrity. To achieve this, any computerized system utilized in these environments must be validated to prove it consistently operates as intended. The definitive roadmap for achieving this state of control is outlined in ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) | GAMP . Without GAMP 5, validation often devolves into a mountain of redundant paperwork that slows down innovation without actually making systems any safer.
Understanding What is GAMP 5: Definition and History
To understand what is GAMP 5, it helps to look at where it came from. The Good Automated Manufacturing Practice (GAMP) forum was founded in 1991 in the United Kingdom by a group of industry professionals who wanted to address the US FDA's growing, and often confusing, expectations regarding automated manufacturing systems.
What started as a regional initiative quickly went global. The first formal GAMP guideline was published in 1995 under the wing of the International Society for Pharmaceutical Engineering (ISPE). Over the years, the framework evolved to keep pace with technology:
1995: GAMP 1 is published.
2001: GAMP 4 introduces a more structured approach to software categories.
2008: GAMP 5 is released, shifting the industry from a rigid "one-size-fits-all" testing model to a flexible, risk-based lifecycle approach.
2022: The GAMP 5 Second Edition is released. This major update addresses modern software environments, including cloud-based SaaS, Agile development methodologies, and artificial intelligence.
Today, GAMP 5 is not just a document; it is a global Community of Practice within ISPE. For a deeper dive into the structured roadmap of these documents, check out our guide on GAMP 5 Guidance.
Is it a Regulation? How Regulators Use What is GAMP 5
A common point of confusion is whether GAMP 5 is a law. No, GAMP 5 is not an official regulation.
Regulations are legally binding rules passed by government bodies—such as the US FDA's 21 CFR Part 11 (governing electronic records and signatures) or the European Medicines Agency's EMA Annex 11 (covering computerized systems).
Instead, GAMP 5 is an industry guideline. However, it was developed in close collaboration with regulatory agencies worldwide, including the FDA, MHRA, and HPRA. Because it represents the consensus of global experts on how to satisfy regulatory expectations, inspectors from these agencies are highly trained in GAMP 5 principles. When an auditor steps into your facility in Edinburgh or Indianapolis, they will expect your validation strategy to align with GAMP 5 logic. If you are following the GAMP framework, you are speaking the same language as the inspector, which makes proving compliance significantly easier. Learn more about how this connects to the broader validation process in our overview of GAMP 5 Validation.
The Core Principles of GAMP 5
At its heart, GAMP 5 is built on five core principles designed to keep validation practical, science-based, and focused on what truly matters.
Product and Process Understanding: You cannot validate a system if you do not understand the manufacturing process or clinical workflow it supports. Validation must start with a clear picture of how the system impacts the final product and, ultimately, the patient.
Lifecycle Approach Within a QMS: Computerized systems are not static. They have a lifespan that must be managed from initial conception through decommissioning within a structured Quality Management System (QMS).
Scalable Lifecycle Activities: The depth of your validation should scale based on the system's complexity, novelty, and risk. A simple, off-the-shelf lab scale does not require the same validation effort as a custom-coded Manufacturing Execution System (MES).
Science-Based Quality Risk Management: Aligned with the international ICH Q9 guidelines for Quality Risk Management, GAMP 5 encourages teams to identify potential hazards to patient safety, product quality, and data integrity. Decisions about what, where, and how much to test should be driven by this risk assessment.
Leveraging Supplier Involvement: Regulated companies shouldn't duplicate work that software vendors have already done. If a supplier has a robust software development lifecycle and quality system, you can—and should—leverage their testing documentation to streamline your own validation.
The System Lifecycle Phases
GAMP 5 outlines a clear, four-phase lifecycle for every computerized system:
Concept: This is the "what do we need?" phase. The organization identifies a business need, determines if the system has GxP impact, and begins defining high-level requirements.
Project: The system is selected, designed, configured, tested, and released. This is where traditional validation activities occur, including writing the User Requirements Specification (URS), performing risk assessments, and executing test protocols.
Operation: The longest phase of the lifecycle. Here, the system is actively used. Compliance is maintained through strict change control, security patching, periodic reviews, and monitoring for configuration drift.
Retirement: When a system is no longer needed, it must be decommissioned gracefully. This involves archiving data securely, ensuring long-term record accessibility, and safely shutting down hardware.
Data Integrity and ALCOA+
Data is the product. Regulators cannot physically inspect every tablet or syringe, so they inspect the data that proves those products were made safely. Data integrity failures—such as deleted audit trails, shared passwords, or unrecorded testing failures—remain a leading cause of regulatory action.
GAMP 5 addresses this by integrating ALCOA+ principles directly into the system lifecycle. ALCOA+ dictates that all GxP data must be:
Attributable (who recorded it?)
Legible (can it be read?)
Contemporaneous (recorded in real-time)
Original (first recording or true copy)
Accurate (free from errors)
The "+" adds complete, consistent, enduring, and available. A robust GAMP 5 strategy ensures that features like system audit trails, access controls, and automated backups are fully verified. For a deep dive into protecting your electronic records, check out our guide on GAMP 5 Data Integrity.
The GAMP 5 V-Model and Software Categories
To structure validation activities, GAMP 5 traditionally utilizes the V-Model. Think of the V-Model as a bridge where the left side represents the specifications (defining what the system should do) and the right side represents verification (proving the system actually does it).
The V-Model connects these two sides with a Traceability Matrix, ensuring that every single user requirement is mapped to a functional specification, design element, and corresponding test case.
Crucially, GAMP 5 distinguishes between:
Verification: Technical testing to ensure the system was built correctly according to specifications (e.g., "Did we build the system right?").
Validation: High-level testing to prove the system meets the user's business needs in their actual operational environment (e.g., "Did we build the right system?").
To learn how to structure this process for your next project, explore our detailed breakdown of the GAMP 5 V-Model.
The Four Active Software Categories
To make validation scalable, GAMP 5 groups software into categories. These categories indicate how complex a system is and how much custom code is involved, directly dictating your validation strategy.
(Note: Category 2, which originally covered firmware, was removed in GAMP 5 because modern firmware is too complex to treat as a single category. Firmware is now classified under Categories 3, 4, or 5 based on its configurability.)
GAMP 5 Category Software Type Description Validation Effort Examples Category 1 Infrastructure Software Operating systems, database engines, and network management tools. Low: Verify installation, version control, and maintain security patching. Windows Server, SQL Server, Oracle Database Category 3 Non-Configurable Software Off-the-shelf software used exactly as-is without changing code or workflows. Medium: Verify installation and test default functions against user requirements. Standard laboratory instrument software, Microsoft Excel (basic use) Category 4 Configurable Software Standard software platforms where you can configure workflows, business rules, and user roles without writing custom code. High: Focus validation heavily on the configuration specifications and critical workflows. LIMS, ERP systems, eQMS platforms, Veeva Category 5 Custom Software Software written from scratch or heavily modified with custom code/scripts to meet unique business needs. Very High: Requires full software development lifecycle (SDLC) validation, including code reviews. Custom MES, complex Excel spreadsheets with custom VBA macros, AI models
Choosing the wrong category can either expose you to regulatory risk or cause you to waste months on unnecessary documentation. Read more about how to correctly classify your applications in our guide on GAMP 5 Software Categories.
Modern Technology: Agile, Cloud, and AI/ML
The technology landscape in 2026 is vastly different from 2008. The GAMP 5 Second Edition (2022) addressed this head-on, shifting the validation paradigm to support modern development models:
Agile Development: Traditional validation assumed a linear, Waterfall approach (design everything, build everything, test everything). GAMP 5 Second Edition explicitly supports Agile, explaining how the V-Model can be broken down into iterative, sprint-based "mini-V" cycles.
Cloud & SaaS Validation: With Software-as-a-Service, the vendor manages the infrastructure and continuously pushes updates. GAMP 5 guides regulated companies on how to perform robust supplier assessments and leverage vendor testing so they don't have to re-validate the entire platform with every minor cloud patch.
AI and Machine Learning: AI/ML systems present a unique challenge because their behavior changes as they learn from new data. GAMP 5 provides framework guidance on validating these systems by focusing on data governance, training data integrity, and model explainability.
This modernization aligns closely with the FDA's Computer Software Assurance (CSA) initiative, which encourages life sciences companies to shift their focus from generating paper records to applying critical thinking and unscripted testing. For an academic look at how these methodologies interact with Quality by Design, see the paper on the Impact of GAMP 5, data integrity and QbD on quality assurance in ... .
Frequently Asked Questions about GAMP 5
Why was GAMP 5 Category 2 removed?
Category 2 was originally reserved for firmware and basic programmable logic controllers (PLCs). As technology progressed, firmware became highly complex, often behaving like configurable software or custom operating systems. Rather than keeping a confusing and outdated classification, the ISPE removed Category 2. Firmware is now classified under Category 3 (if it is non-configurable), Category 4 (if it can be configured), or Category 5 (if it contains custom code).
Can a single system span multiple GAMP 5 categories?
Absolutely. This is known as the "continuum concept." For example, a modern ERP system is typically a Category 4 (configurable) application. However, it runs on a Category 1 database engine (like SQL Server). If your IT team writes a custom SQL script to generate a unique batch release report, that specific reporting module is considered Category 5 (custom).
The key is to evaluate your system component-by-component, applying the appropriate level of validation rigor to each part rather than over-validating the entire infrastructure. Read more about how to handle these hybrid scenarios in our guide on GAMP 5 Category.
What is the difference between CSV and CSA in GAMP 5?
Computer System Validation (CSV) is the traditional approach that often focuses heavily on creating massive volumes of scripted test cases and screenshots to prove compliance. Computer Software Assurance (CSA) is a modern approach championed by the FDA and fully embraced by the GAMP 5 Second Edition. CSA emphasizes critical thinking, risk-based testing, and unscripted testing for low-risk features, allowing teams to reduce documentation by up to 80% while actually improving software quality.
Conclusion
Understanding what is GAMP 5 is the first step toward transforming your compliance strategy from a painful bureaucratic bottleneck into a streamlined, risk-based engineering discipline. By focusing your validation efforts on patient safety, product quality, and data integrity, you protect your business from audit findings while accelerating your time-to-market.
At Valkit.ai, we live and breathe these principles. Operating from our offices in Scotland and Indiana, we provide an AI-powered digital validation platform designed specifically for the pharmaceutical, biotech, and medical device industries.
By leveraging smart automations, system cloning, and digital compliance tools, we help organizations reduce validation costs by up to 80% and shrink project timelines from weeks to hours—all while maintaining bulletproof compliance.
Ready to leave paper-heavy, slow validation processes in the past? Transform your validation with Valkit.ai today and see how easy compliance can be when you have the right tools in your corner.
