Pharma Connections emphasizes the importance of adopting a risk-based approach to validation. Last year, the International Society for Pharmaceutical Engineering (ISPE) released its second edition of GAMP 5, titled “A Risk-Based Approach to Compliant GxP Computerized Systems.” This edition aims to align validation activities with the complexity of design and the risks associated with the software’s intended use.

Traditionally, system validation has relied heavily on a documentation-focused process that uses checklists, templates, and predefined procedures to test and document system components. Consequently, validation efforts often centered on producing documentation to demonstrate regulatory compliance, rather than ensuring that high-risk functionalities operated correctly. This led to a validation process that was more burdensome than necessary and missed opportunities to understand the system’s optimal use in a GxP environment.

As a result, critical thinking was sometimes lacking in the risk assessment process. Recognizing this, the FDA noted the need for clearer guidance to ensure that risk-based approaches focused on intended use were implemented. In 2018, the FDA published Q&A guidance on Data Integrity and Compliance with Drug cGMP, stating that validation should prioritize consistent intended performance and incorporate a risk-based approach. This entails applying critical thinking to prioritize validation efforts according to the level of risk associated with the computer system.

Implementing a quality and compliance management software solution can indeed seem daunting, especially in the life sciences sector, where validation costs and regulatory requirements loom large. However, with a structured GxP validation process, the task becomes more manageable. Here’s how Pharma Connections streamlines this process:

Automating Vendor Test Scripts to Enhance Confidence

Pharma Connections supports the industry consensus that automation is key to achieving control, quality, and risk reduction during the validation process. Many technology vendors provide automated test scripts designed to ensure the system operates as intended. These scripts run automatically, alerting users if any specifications are not met. For instance, automated operational qualification (OQ) testing during implementation verifies that equipment functions properly and remains within manufacturer-approved operating ranges.

Moreover, vendors may offer customized performance qualification (PQ) testing tailored to specific use cases, which can be a cost-effective solution for users.

By utilizing PQ test scripts, system users can concentrate on high-risk areas identified in vendor risk assessments. These critical areas often include audit trails, electronic signatures, regulatory compliance, and data integrity—significantly relevant, as 65% of FDA warning letters in 2021 cited data integrity issues.

It is noted the value of establishing automated test scripts that run on a predefined schedule, providing alerts for any failures, provided that these failures are monitored and addressed promptly.

Automating test scripts supports the system throughout its lifecycle, reducing the time and resources typically spent on manual script development and execution. This approach streamlines repeated tests that are unlikely to change, ensuring quality while expediting timelines.

Control Validation Costs

GxP software validation is crucial for compliance with FDA, MHRA, and ISO 13485 standards. While you can’t eliminate validation costs entirely, Ideagen focuses on making the process as efficient and seamless as possible.

How Pharma Connections Supports You

1. Plan
   • Your dedicated Service Implementation Manager collaborates with you to outline validation activities. Key deliverables include:
     • Validation Master Plan
     • User Requirements Specifications (URS)
     • System Functional Specifications
     • Configuration Plans
     • Operational Qualification (OQ) Test Plans
     • Validation Traceability Matrix
   • If you don’t have existing templates, we can provide them and guide you through essential questions to ensure comprehensive coverage aligned with your URS and relevant regulations.
2. Build
   • Our installation experts set up your system, ensuring a smooth QMS implementation. We offer a full suite of professional services to minimize disruption and maximize your investment’s return.
3. Configure
   • Your Service Implementation Manager will tailor the solution to meet your specific business needs, documenting configuration details in the traceability matrix to ensure all requirements and functions are addressed.
4. Test
   • The testing phase confirms that the system meets key operational and security functions. We provide training, onboarding plans, and OQ support, including validation test scripts. Together, we will review these scripts to demonstrate how to fulfill requirements within the system.
5. Review
   • After configuration and testing, we offer various support templates and services to ensure the software meets your expectations. Known as Performance Qualification (PQ), this phase includes retesting and reviewing Standard Operating Procedures (SOPs) and change control. Validation sign-off occurs on a modular basis, requiring mutual review. Once all modules are approved, we conduct a final review of the entire validation support process.

By following these steps, Pharma Connections helps to alleviate the stress of software validation, allowing you to focus on what really matters—delivering quality and compliant products.

Pharma Connections also provides training courses in Computer system validation, computer software assurance and other courses relevant to life science domain.

 Is Your Documentation Accurate, Comprehensible, and Accessible?

Inadequate validation of electronic record-keeping is a common reason for FDA 483 citations and warning letters. The computer systems involved are crucial for maintaining control over your processes.

If you haven’t undertaken a computer system validation project before, you may not fully understand the relevant regulatory requirements or how to define the scope of your testing.

Failure to properly validate GxP computer systems can lead to significant internal issues, such as loss of critical data, as well as external consequences like regulatory actions.

This presentation outlines a step-by-step approach for planning, executing, and reporting on computer system validation activities. Validation documents serve as auditable records that are frequently reviewed during regulatory inspections. Therefore, it’s essential not only to conduct testing that verifies the system operates as intended but also to thoroughly document your testing efforts and the rationale for the chosen extent of testing. You will also receive tips on effectively managing testing resources to save both time and money.

What’s the Purpose of GxP?

The primary purpose of GxP is to safeguard consumers. These guidelines are established and enforced by regulatory agencies, such as the United States Food and Drug Administration (FDA) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Their goal is to ensure that products, research, and projects are conducted safely, resulting in end products that are safe for use.

GxP guidelines represent the minimum requirements organizations must meet to maintain consistently high quality in their goods and services. They specifically address products or projects that may pose risks to public safety, making GxP compliance essential for food, pharmaceutical, medical device, and life sciences organizations, as well as any companies operating within regulated industries.

GxP Regulations

As previously mentioned, there are numerous guidelines that vary by country and region. Covering all of them would take considerable time. For the sake of brevity, let’s focus on one of the most important and widely applicable GxP frameworks: Good Manufacturing Practices (GMP).

What Are GMP and cGMP?

Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (cGMP) are quality standards that companies in the food, cosmetics, medical device, and pharmaceutical sectors must follow. These regulations ensure that manufacturers consistently produce high-quality products that are safe for consumers. Generally, GMP guidelines outline rules for manufacturing, testing, and quality assurance.

What Do the Regulations Look Like?

There are numerous guidelines in place, but some key GMP regulations that manufacturers must adhere to include:

– Cleanliness: Manufacturing areas must be maintained in a clean and hygienic condition.

– Controlled Environment: Production must occur in an environment designed to prevent cross-contamination.

– Defined Processes: All manufacturing processes should be clearly defined and controlled, with any changes evaluated and validated.

– Standard Operating Procedures: Standard operating procedures must be clearly documented and accessible.

– Process Recording: The manufacturing process needs to be recorded to demonstrate that all required procedures and instructions were followed correctly.

– Quality Investigation: Any identified quality defects must be investigated, and corrective actions should be implemented to prevent recurrence in the future.