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Compliance with GAMP 5 guidance: A checklist

Pharmaceutical and healthcare companies are increasingly using automation to improve productivity and lower costs. But despite the technology’s numerous benefits, automation also exposes businesses and consumers to greater risk. To mitigate this, the International Society of Pharmaceutical Engineering recommends using the latest Good Automated Manufacturing Practices (GAMP 5) guidelines to reduce risk and streamline the development of automated systems.


In this post, you’ll find an overview of the GAMP 5 framework, including why it matters and whether it’s mandatory. At the end of the post, we’ve included a GAMP 5 checklist that’ll help you stay compliant.

What are GAMP 5 guidelines?

GAMP is a risk-based framework for validating and controlling digital healthcare and pharmaceutical systems. The International Society for Pharmaceutical Engineering (ISPE) released the framework back in 1994, and it’s currently in its fifth version. The GAMP framework offers common automation terminologies as well as best practices. It also contains resources for documentation, procedures, testing, and user requirements.

GAMP 5 guiding principles help organizations:

  1. Understand the product and process clearly
  2. Use a quality management system (QoS) to manage the system lifecycle
  3. Scale all lifecycle activities
  4. Verify that they’re using a science-based approach to risk management
  5. Integrate suppliers throughout the system

Why is GAMP 5 important?

GAMP is not mandatory, nor is it a legally binding framework, but it remains the industry standard for validating automated systems. Developers in regulated industries typically use GAMP 5 to go to market with greater efficiency and less risk. With that in mind, let’s examine some of the top benefits of adopting GAMP 5 guidelines in your developer environment.

  • Avoiding noncompliance penalties. Regulated companies are often required to adhere to multiple engineering frameworks from governments and regulatory agencies. Adopting GAMP makes it easier to comply with different regulations and avoid costly penalties.
  • Improving automation. Many businesses struggle with low ROI from their automation systems due to a lack of standardization and poor system performance. Following GAMP guidelines leads to higher-quality automation with fewer errors. This, in turn, delivers greater productivity and more robust financial returns.
  • Boosting scalability. GAMP 5 focuses on standardizing automated systems during the implementation and validation stages. Standardizing automation makes it faster and easier to scale automation deeper across your operations.

What are GAMP 5 software categories?

When using the GAMP 5 framework, one of the first steps is to classify your software based on its impact on individual regulated processes. With that in mind, here’s a breakdown of the different software categories within the GAMP 5 framework.

  • Infrastructure. Infrastructure software focuses on the underlying components that support your system. These may include network infrastructure, operating system, database management system, and supporting software.
  • Nonconfigurable. As the name suggests, nonconfigurable software refers to commercial applications that come without any custom modifications or configurations, like analysis and monitoring tools.
  • Configurable. Configurable software typically contains modifications that enable systems to align with specific workflows and processes. In some cases, configurable software may affect end-user safety or product quality.
  • Custom. Custom software involves proprietary software explicitly made for an internal workflow or team. This type of software requires comprehensive testing and validation to ensure it remains reliable and usable in a regulated environment.
  • Bespoke. GAMP also contains a category for bespoke software, or products developed using proprietary technologies. Bespoke software also requires advanced testing and validation.

How Tricentis Vera™ streamlines regulatory compliance 

As you can see, achieving and maintaining GAMP 5 compliance requires significant effort. With the help of a digital validation platform like Tricentis Vera, staying compliant is much easier and your business can make the leap from a document-based validation system to one that is modern and seamless. Vera streamlines software compliance from end to end, allowing developers to move faster and more efficiently while also reducing risk.

To see Vera with your own eyes, request a demo.

This post was written by Justin Reynolds. Justin is a freelance writer who enjoys telling stories about how technology, science, and creativity can help workers be more productive. In his spare time, he likes seeing or playing live music, hiking, and traveling.