In today’s market, it’s vital to understand product quality in terms of both the regulatory landscape and customer needs.
Enterprise companies, and those aiming to become enterprise-level, often face compliance requirements from numerous regulatory authorities such as CFR 21, ISO 9001:2015, and CGMP, in addition to ever-increasing standards from the consumers themselves.
The topic of quality validation is commonly associated with highly regulated industries such as healthcare or life sciences (for instance, medical devices, the pharmaceutical industry, and biotechnology) because ensuring compliance with stringent regulations and standards directly affects the health and safety of patients.
While true, a focus on product quality methodology is becoming more and more critical to all types of product companies given the rising standards of consumers themselves, and their unprecedented access to information online.
This guide explores the key aspects of quality validation processes in these industries, with a specific focus on the differences between modern software solutions versus traditional on-premise systems.
It’s essential to consider the scope of these growing quality demands with regard to your business systems, fiscal capacity, and process efficiency. Failing to plan is planning to fail, but luckily you seem like a planner—that’s why you’re reading this!
Let’s review the cornerstones of validation, how they work together to achieve compliance, and how today’s approach to building a solid, compliant validation looks surprisingly different from what you might be familiar with.
What is quality validation?
Let’s cover some validation basics first, just so we are all on the same page.
(Consider this a basic refresher; you can skip ahead to get into the meat of how things have changed but think of this as a light appetizer before the main course.)
Quality validation involves working closely with vendors to establish installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ) that align with specific business needs.
The IQ focuses on the technology requirements, the OQ looks at standard operating procedures (SOPs) while the PQ focuses on the processes and protocols unique to the business.
Sometimes a simple model helps to better understand what these terms mean. To that end, let’s consider a toaster:
- IQ: Is the system installed correctly per the manufacturer’s requirements? –> Is the toaster plugged into your wall socket, and is that wall socket live?
- OQ: Does the system meet standard operating procedure qualifications? –> What are the standard operating procedures for a toaster? Does this particular toaster meet these qualifications?
- PQ: Does the system perform to meet your specific business process (which may or may not deviate to any degree from the standard procedures)? –> How do you intend to use the toaster? How will you demonstrate that it meets your needs, specifically?
Collaboration with vendors is crucial in establishing these qualifications.
Steps of the Validation Process
We do have to emphasize that there is no one-size-fits-all validation process. Your company and its products must answer to your regulatory bodies and your market and consumer demands, which will vastly differentiate your validation needs.
That said, there are a few core critical steps that make up the broad structure of validation, helping ensure that manufacturing processes and software systems demonstrate high-quality compliance with standards and regulatory requirements:
- Assessment and Scope Definition: Conduct an initial assessment to define the intended use of the software solution and determine the scope of validation activities. From the perspective of both the customer and the vendor, assessments play a key role. This step aligns with the requirements of regulatory authorities, such as the FDA, and ensures the validation efforts are appropriately focused.
- Validation Plan Development: Create a comprehensive validation plan that outlines the validation approach, risk assessment, quality standards, and deliverables. This plan serves as a roadmap for the entire validation process, and the foundation for your subsequent validations.
- Protocol Creation and Execution: Develop protocols to validate the software system and associated equipment. These protocols define test cases, data collection methods, and success criteria for validation activities. Note that vendors have a great opportunity to aid you in demonstrating compliance with their OQ documentation, and templates to expedite your IQ and PQ work.
- Characterization and Validation Testing: Perform rigorous testing to characterize the software system's performance and validate its functionality, reliability, and compliance with regulatory requirements. This step involves executing validation protocols, documenting results, and addressing any deviations or non-conformances.
- Documentation and Reporting: Maintain thorough documentation throughout the validation process, including validation protocols, test results, deviations, and corrective actions. Proper documentation ensures traceability, accountability, and the ability to demonstrate compliance during regulatory inspections.
Modern vs Traditional Validation Processes
Modern software solutions should offer improved qualification solutions compared to traditional systems, with the ability to track and analyze specific changes over time. This is a fundamental shift in approach from on-prem systems.
In the past, on-prem solutions mitigated risk through a waterfall approach, making all changes at once in an effort to minimize exposure and ensure the highest likelihood of success.
However, as you may be well aware, this approach leads to a cumbersome process of assessing impacts and testing everything for each update request. It often results in a heavy reliance on documentation, which provided some sense of comfort at the costly expense of precious time and resources, which naturally extended deadlines, increased budgets, and limited growth.
The emphasis on documentation stems from the belief that having everything recorded offered protection in challenging situations (or as my professor used to say, when “it” hits the fan, you want to be covered in paper.)
Modern solutions take a blended approach for the better. They don’t discount the value of specific documentation, traceability, and risk analysis. The improvement lies in the enhanced impact analysis and granularity provided by better technology. Vendors have a deeper understanding of how their products interact between the core code and business use cases.
Consequently, when it comes to validating processes, it becomes crucial to identify the specific areas and elements affected by changes and minimize unnecessary overhead.
The focus shifts from producing excessive documentation to producing effective documentation.
3 Key Benefits of Modern Solutions for Validation
Validation processes in regulated industries require adherence to various standards set forth by regulatory bodies, such as the U.S. Food and Drug Administration (FDA), International Organization for Standardization (ISO), and Good Manufacturing Practice (GMP) guidelines.
It’s our belief that successful, regulated businesses should target efficient validation processes, producing effective quality documentation while minimizing overhead and time spent. This is where vendors can dramatically impact bottom lines. When comparing modern software solutions to traditional on-premise systems, we often see the following differences:
- Enhanced Lifecycle Management: Modern software solutions offer streamlined lifecycle management capabilities, ensuring that validation activities are seamlessly integrated throughout the software development lifecycle. This facilitates efficient process validation and reduces the time and effort required for compliance.
- Integration of Quality Management: Modern solutions provide robust quality management functionalities, enabling organizations to establish and maintain their validation activities within a comprehensive quality management system (QMS). This ensures that quality control, quality assurance, and documentation processes are seamlessly integrated into the validation process.
- Improved Supply Chain Integration: Modern software solutions offer enhanced supply chain integration, enabling organizations to effectively manage and validate their manufacturing processes across the entire supply chain. This ensures consistent quality standards and facilitates regulatory compliance.
- Natural Risk Reduction: The above points sum together to provide a far more cost-effective method to reduce your business and compliance risk, while not requiring increases in organizational overhead or delays in delivery dates.
Best Practices for Quality Validation
Much like the steps outlined above, validation best practices will also vary widely depending on the product you’re producing, the industry you belong to, and the market you’re targeting.
Allowing for your company’s particular validation needs, consider the following recommendations:
Implement a Robust Quality Management System
Integrate all your quality activities within a comprehensive quality management system (QMS) that encompasses all aspects of validation, quality control, and quality assurance. Align the QMS with relevant regulatory requirements, such as GMP and ISO standards, to ensure compliance and facilitate effective quality management. With modern QMS solutions, you can connect your PLM and field service activities directly within the same platform, so all product quality concerns are disseminated and addressed instantaneously.
Ensure Project Management Discipline
Adopt sound project management principles to effectively plan, execute, and control validation activities. This includes defining clear roles and responsibilities, establishing timelines, and managing resources and stakeholders throughout the validation lifecycle.
Perform Equipment Qualification and Calibration
Ensure proper equipment qualification and calibration processes are in place to guarantee the accuracy, reliability, and traceability of measurement and testing equipment used in the validation process.
Continuously Improve the Quality Validation Process
Regularly review and refine the validation process based on lessons learned, industry best practices, and feedback from regulatory authorities. Embrace a culture of continuous improvement to enhance the effectiveness and efficiency of validation activities.
A Simpler Way to Validate
In regulated industries, effective quality validation processes are vital to ensure compliance, maintain product quality, and protect consumer safety. By leveraging modern software solutions, organizations can streamline their verification and validation efforts, integrate quality management practices, and achieve regulatory compliance more efficiently.
Incorporating a modern solution such as Propel Software into the quality validation process offers distinct advantages. For example, Propel provides ready-to-use templates that expedite protocol creation and execution, enabling organizations to make significant progress in their validation efforts. Additionally, the IQ feature ensures a solid foundation for configuration, while the comprehensive OQ protocols instill confidence in the software system's performance and compliance.
By leveraging Propel's capabilities, organizations can enhance the efficiency and effectiveness of their quality validation processes, enabling them to navigate regulatory requirements with ease and maintain robust product quality.
Learn more about how a modern solution like Propel Software can transform and evolve your Compliance Management. Click here to get a product tour or request a demo.