ALM-Based GxP Validation

Computer system validation (CSV) is required in various regulated industries that rely on computer systems to support their operations. It is a documented process that ensures a computer system, including software and hardware, consistently produces results that meet predefined requirements and quality standards. It involves verifying and documenting that a computer system performs reliably, accurately, and securely throughout its lifecycle. Well-known regulations that mandate computer system validation include US FDA 21 CFR Part 11 and European Union, Volume 4, Annex 11.

Most companies follow the GAMP®5 V-Model to validate their systems. The left-hand side of the V-model represents what you want the computer system to do. The right-hand side of it represents how you test the system to confirm that the system performs as described in the corresponding specification.

• Planning: Define the scope of the validation effort, including the system’s boundaries and functions. Identify and assess potential risks associated with the system's use, data integrity, security, and regulatory compliance.
• User requirement specification: Define and document the computer system’s specific requirements, including functionality, security, performance, and regulatory compliance.
• Functional specification: Translate the user requirements into technical specifications. Define how the system will fulfill user needs and specify its functions and features.
• Design specification: Develop detailed design documents that outline the system’s technical architecture, interfaces, algorithms, and data structures.
• Configuration and/or coding: Develop or purchase and then configure the software (depending on the software category) to meet the criteria laid out in the specification documents.
• Installation qualification (IQ): Verify that the system is correctly installed and configured per specifications, including hardware, software, and network components.
• Operational qualification (OQ): Conduct comprehensive testing to verify that the system consistently performs as intended under various operational conditions.
• Performance qualification (PQ): Test the system under simulated or normal operating conditions to ensure it performs as expected and meets predefined requirements.
• Reporting: Create and maintain all necessary documentation, including validation plans, test protocols, traceability matrices, test results, deviations, and corrective actions, to prove compliance. Summarize all validation documentation into a final validation report.

Use OpenText ALM tools to manage these steps together systematically and efficiently.

GxP is a general abbreviation for the "good practice" quality guidelines in regulated industries such as food, drugs, bio products, medical devices, and cosmetics. For example, the guideline for computer system validation is called GAMP®5 (5th version of Good Automated Manufacturing Practice). There are some other ‘good practice’ guidelines with the purpose of ensuring a product or service is safe and meets its intended use, such as:

- GCLP (Good Clinical Laboratory Practice)(WHO guidelines)
- GCMP (Good Current Manufacturing Practice)(FDA regulation covering pharmaceutical manufacturing, distribution, and storage)
- GDP (Good Distribution Practice)(European Medicines Agency regulation)

These guidelines all involve a combination of planning, implementation, monitoring, auditing, and continuous improvement. The applicable target product goes beyond computer systems, but a similar approach applies.

GxP validation is the process of establishing documentary evidence showing that systems, equipment, and processes meet regulatory requirements, maintain data integrity, and produce consistent and reliable results. Computer system validation is one type of GxP validation.

GxP validation is crucial for several reasons:

• People’s safety: GxP validation ensures that products, processes, and equipment in regulated industries are designed, manufactured, tested, and distributed in a manner that guarantees people’s safety. It helps prevent errors, contamination, and other issues that could lead to harm.
• Regulatory compliance: Many industries, such as pharmaceuticals and healthcare, have strict regulatory requirements. Validation helps organizations prove compliance, avoiding legal and financial consequences.
• Risk mitigation: Validation helps identify and mitigate potential risks, which can have severe consequences for business operations and reputation.
• Product quality: By validating, organizations can ensure that the products/services produced are accurate, consistent, and reliable, thereby maintaining high levels of product or service quality.
• Cost savings: Investing in validation upfront can prevent costly errors, rework, and system failures down the line. It helps identify and resolve issues early in the development process, saving time, resources, and potential financial losses.

Computer system validation is a collaborative effort involving multiple stakeholders within an organization. The responsibilities typically include:

• Business or product owners: They define the requirements and provide the necessary resources for validation.
• IT department: They configure, implement, and maintain the involved IT systems.
• Quality assurance and validation teams: They oversee the validation process, create validation plans, develop protocols, execute tests, and document the results.
• Risk and Compliance teams: They ensure that the validation activities meet regulatory requirements and industry standards.

Validation of computer systems and non-computer products have many similarities. Though the target products in GxP validation go beyond computer systems, OpenText ALM tools can be used to manage GxP validation processes and activities because these tools have comprehensive features for test management, quality management and lifecycle management.

The frequency of validation depends on a range of factors, including the product’s criticality, regulatory requirements, and product changes. Typically, validation activities are initially performed when a product is introduced or has significant changes, followed by periodic revalidation or review cycles. A product that has received warnings during an audit by the regulatory body will need more frequent validation afterwards, until all the warnings are addressed. A robust process can ensure stringent tests and avoid rework. OpenText ALM tools let you continuously stay compliant to save on the cost of rework and revalidation.

Yes, GxP validation can be outsourced to specialized validation service providers or consultants who have expertise in validation. Outsourcing can be a practical option, especially for organizations without in-house validation capabilities or when more expertise is required for complex systems or regulations.