How to use critical thinking to choose the best eQMS vendor

The discussion, led by CSA expert Sion Wyn, focuses on the critical role of informed judgment and technological insight in the vendor selection process for computerized systems, specifically within regulated environments like the pharmaceutical and life sciences industries. The central thesis is that regulated companies must employ "critical thinking" when evaluating suppliers of software (such as eQMS vendors) because the majority of the software development and quality assurance is conducted within the supplier’s own quality system. This places the onus on the regulated firm to rigorously assess the vendor’s internal practices, tools, and overall technological maturity.

The speaker emphasizes that a key component of critical thinking involves recognizing and rejecting outdated methodologies. If a potential supplier relies heavily on paper-based documentation or is bogged down by excessive, traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) procedures, this indicates a lack of modernization. Such a supplier is deemed "not up-to-date." Conversely, a high-quality supplier utilizes modern toolsets, adheres to current good development practices, and follows robust IT quality system frameworks (such as ISO or similar standards) to manage operations and service delivery. These modern practices are characterized by automation, which fundamentally changes how documentation and information management are handled compared to two decades ago.

A crucial insight provided is the necessity for the regulated company to staff its vendor assessment team with the right expertise. These individuals must possess the requisite "technological insight" to discern what constitutes good, modern technology, processes, and documentation. The standard for "good technology" has evolved significantly over the last 25 years, moving toward automated, streamlined systems that inherently manage quality and compliance. Therefore, the assessment process must shift from merely checking boxes on voluminous documentation to verifying the sophistication and compliance of the supplier’s underlying development and quality management processes. This ensures that the regulated company selects a partner whose methodology supports efficient, compliant operations, rather than one that perpetuates manual, outdated validation burdens.

Key Takeaways: • Supplier Quality System Assessment: The primary focus of critical thinking in vendor selection must be the assessment of the supplier’s internal quality system and development environment, as this is where the core compliance and quality assurance for the software is established. • Rejection of Antiquated Practices: Regulated companies must use critical thinking to identify and disqualify potential suppliers who rely on outdated, paper-intensive quality systems or excessive, traditional IQ/OQ/PQ documentation, which signals a lack of technological maturity. • Technological Insight is Mandatory: The personnel within the regulated company responsible for assessing computerized system suppliers must possess deep technological insight to accurately judge the modernity, efficiency, and compliance of the vendor’s tools and processes. • Automation as the Modern Standard: Good technology and processes are defined by high levels of automation in development, documentation, and information management, reflecting a necessary departure from the manual methods prevalent 25 years ago. • Current Good Development Practice: A high-quality supplier should be demonstrably following current good development practices and leveraging established IT quality system frameworks (e.g., ISO standards) for managing service delivery and operations. • Focus on Process Over Paper: The vendor assessment process should prioritize verifying the robustness and compliance of the supplier’s automated development and quality management processes, rather than simply accumulating large volumes of manually generated validation documentation. • Strategic Vendor Selection: Choosing a technologically advanced supplier that embraces automation and modern quality frameworks is a strategic move that streamlines the regulated company’s own compliance burden and ensures the adoption of systems that are fit for modern regulatory requirements (like those emphasizing Computer Software Assurance, or CSA). • Internal Expertise Gap: If the regulated company lacks the internal technological expertise to properly evaluate modern, automated systems, they risk selecting vendors whose processes will ultimately create bottlenecks and compliance challenges down the line.

Key Concepts:

• Critical Thinking in Sourcing: Applying informed, objective judgment to assess a supplier's quality system and technological maturity, moving beyond simple checklist validation.
• Current Good Development Practice: Modern software development methodologies that integrate quality and compliance throughout the lifecycle, often leveraging automation and continuous integration/continuous delivery (CI/CD) pipelines.
• Technological Insight: The necessary expertise within the regulated company to understand and evaluate modern automated systems, distinguishing them from outdated, documentation-heavy approaches.
• IQ/OQ/PQ (Installation, Operational, Performance Qualification): Traditional validation protocols often associated with older, manual systems. The speaker implies that excessive reliance on these manual processes indicates a non-modernized supplier.