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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.

Checklist for GAMP 5 compliance

When implementing GAMP 5, you’ll need to consider your product and specific regulatory requirements for your industry. It’s also important to account for any cross-industry regulations that may apply. Use the following GAMP 5 compliance checklist to more closely align with the framework.

Vendor selection and evaluation 

Regulatory agencies are increasingly looking down the software supply chain and holding businesses accountable for the vendors they work with. As a result, vendor selection is a top consideration with GAMP 5 compliance.

 

Vendor checklist for GAMP 5 compliance

  • Evaluate all vendors for security, reputation, and ability to deliver.
  • Analyze vendors for any regulatory violations, penalties, or financial challenges.
  • Make sure vendors thoroughly validate, document, and maintain their products.
  • Work with vendors that provide transparency and support.

Functional and design specifications 

Functional and design specifications focus on the exact capabilities and functions that the software must contain. In other words, they describe how the software will behave and how users will interact with it.

 

Functional and design checklist for GAMP 5 compliance

  • Create specifications detailing how the software will meet specific user requirements.
  • Define and document all architectural renderings, data flows, and interfaces within the software.
  • Factor in all security and data protection needs and determine how you will protect your software.
  • Consider a layered security approach with multiple defense mechanisms and privacy components.

Identifying and evaluating user requirements

Part of GAMP 5 involves identifying user requirements and factoring them into your product design.

 

User requirements checklist for GAMP 5 compliance 

  • Consult with stakeholders to identify and document user requirements like needs, preferences, and special accommodations.
  • Define all functional and nonfunctional requirements.
  • Evaluate each requirement based on its overall impact on safety, quality, and data protection.

Verification and testing

Companies need to be able to ensure their software is reliable and capable of performing at a high level. To achieve this, GAMP 5 recommends thorough verification and testing.

 

Verification and testing checklist for GAMP 5 compliance

  • Conduct an initial risk assessment.
  • Analyze the risk assessment and use it to create a thorough testing strategy.
  • Perform a variety of tests, including integration tests, system tests, user acceptance tests, and unit tests.

Operation  

In order to be useful, software must be operationally sound. GAMP 5 offers guidelines for achieving operational excellence.   

 

Operational checklist for GAMP 5 compliance  

  • Implement specific operational controls and procedures.  
  • Offer training for users to help them learn and use your software. 
  • Create a disaster recovery and business continuity strategy to protect your software from outages.  

Contracts and agreements

Companies must use caution when signing agreements with software vendors. GAMP 5 compliance encourages companies to do their due diligence and avoid agreements that could lead to legal issues.   

 

Contracts and agreements checklist for GAMP 5 compliance  

  • Make sure your vendor contracts clearly state responsibilities and deliverables. 
  • Include a provision about data ownership and intellectual property rights.  
  • Ask about the vendor’s network environment, as well as its data storage and data processing policies.  
  • Account for maintenance, support, updates, and potential downtime.

Maintenance and support 

No software is ever fully complete. As such, it’s critical to establish an ongoing maintenance plan to oversee patches, updates, and fixes.   

 

Maintenance and support checklist for GAMP compliance 

  • Create a schedule for maintenance and updates.  
  • Establish a plan for receiving, responding to, and documenting trouble tickets.  
  • Document all maintenance and support requests.  

Performance monitoring 

Today’s software must support fast-paced, data-intensive workloads. As a result, it’s critical to have a performance monitoring system in place that provides visibility into system and network resources.   

 

Performance monitoring checklist for GAMP compliance 

  • Conduct a baseline network assessment before developing software.  
  • Outline key performance indicators and quality metrics that are important for your operation.  
  • Use real-time data processing to deliver instant analytics.  

Periodic review 

User requirements and regulatory specifications can change over time. For this reason, GAMP 5 recommends conducting periodic reviews.   

 

Review checklist for GAMP 5 compliance  

  • Revisit validation documentation whenever the software changes.  
  • Use automation to analyze software end-to-end and track modifications.  
  • Make risk assessment a core part of your reviews and monitor the software’s impact on safety and data protection. 

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.

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