Computer systems are critical to regulated industries like pharmaceutical manufacturing, clinical research, and healthcare. They must meet strict regulatory requirements to ensure data integrity, security, and compliance with GxP standards. This is where computer system validation (CSV) comes in. CSV is an administrative requirement that provides archived proof that an IT framework functions appropriately.

Product and Process Understanding

Computer System Validation is a documented process that provides objective evidence that a computerized system does what it intends to do consistently and reproducibly. Regulatory agencies like the FDA require regulated businesses to have processes to guarantee that computer systems work as they ought to. For lab informatics systems like LIMS, ELN, and CDS that record regulated data during drug discovery, trials, and production, this means establishing an approach to ensure that the data and electronic signatures stored on these systems are trustworthy.

For this reason, it’s essential to understand what computer system validation is, why it’s needed, and how to approach it to achieve success. For example, a fundamental principle emphasized by the GAMP 5 guidance is using a risk-based approach to ensure that the validated computer systems are fit for purpose and continually meet company policies and procedures. This is possible because taking a step back and looking at the overall business process makes it possible to identify potential risks and take measures to minimize them.

This approach is often represented by the classic V Diagram that shows the relationship between requirements and specifications (down the left), the system builds and qualification testing activities that verify those specifications, and finally, reporting and documentation at the bottom right of the V. The key is ensuring the project is planned correctly from the beginning. It includes defining the Validation Master Plan and identifying responsibilities throughout the project.

Critical Functionalities

Regulated companies must ensure that their digital tools will work as designed regarding computer system validation. This considerable responsibility should be taken seriously by regulatory agencies like the FDA. A single bug in a software system could have disastrous consequences if it impacts patient safety, product quality, or data integrity. To put it into perspective, consider the case of Therac-25, a radiation therapy machine from the 1980s that was found to have serious programming issues. The problem caused the device to administer improper dosages of radiation, resulting in painful and deadly side effects.

Fortunately, a new and improved way to approach computer system validation (CSV) exists. The Second Edition of GAMP 5 guidance, published in 2022, takes a holistic approach to CSV by expanding upon the foundational principles of product and process understanding, risk-based adoption, and leveraging supplier activities. The key to a successful CSV cycle is to focus on the critical functionalities most likely to cause a deviation.

The next phase is to build a system to detect and handle these deviations. Combining software, hardware, and manual processes enables users to automate issue reporting. It will allow the system to identify and resolve problems before they become a critical deviation that leads to a product recall.

Scalable Lifecycle Activities

The second principle highlights the importance of a lifecycle approach within an organization’s Quality Management System (QMS). It ensures validation activities are planned, executed, and documented throughout a computerized system’s life cycle, from its initial concept and development to its retirement. This is an essential aspect of computer system validation that helps to prevent potential risks from being overlooked.

The third principle emphasizes a scalable approach when conducting validation activities. It recognizes that the extent and rigor of validation should be commensurate with the complexity, criticality, and impact of a computerized system on patient safety, product quality, data integrity, and other critical business objectives. A scalable approach to validation allows organizations to prioritize resources based on their potential impact and facilitates a more streamlined and efficient process.

Computer system validation is more than necessary in the pharmaceutical production chain. In certain instances, it can even be life-saving, preventing medication defects that could otherwise lead to significant side effects and adverse patient reactions.

As a result, effective and efficient CSV processes are essential to maintaining regulatory compliance. Inefficient or ineffective CSV can result in costly delays, image losses, and, in the worst-case scenario, legal action that could be financially devastating for a company. The best way to avoid such risks is to follow these fundamental principles and best practices for computer system validation.

Supplier Involvement

Computer systems are essential in regulated industries like pharmaceuticals, biotech, natural health products, medical devices, and cosmetics. The reliance on these digital tools increases product reliability, improves patient safety, and ensures systems operate within regulatory requirements. This is why computer system validation is essential to competent risk management.

Regulated companies are rethinking their approach to validating these systems. They’re moving away from in-house developed solutions and instead leveraging the expertise of their suppliers to develop innovative and compliant life sciences solutions. In doing so, they’re also benefitting from savings and efficiencies of scale and reducing long-term system and project costs.

Suppliers are an essential partner in the validation process. They can provide a valuable source of test documentation for their software/hardware and help organizations avoid duplicating efforts that other team members are already performing. The goal is to establish a partnership that leverages each other’s resources for the project’s overall success.

As the FDA continues to release new guidance around computer systems validation (CSA), adopting GAMP 5 guidelines as your foundation for the validation process is best practice. This methodology emphasizes product and process understanding, quality risk management, supplier activities, and system fitness testing.