Leveraging Vendor Testing: A Smarter Approach to Validation

The life sciences industry operates in a high–stakes environment, where precision, compliance, and efficiency are critical. For organizations managing the complexities of validation, the need to optimize processes while meeting regulatory standards is more urgent than ever. By integrating vendor testing into your validation framework, you can reduce redundancy, increase efficiency, and ensure compliance. When paired with digital solutions, vendor testing can further streamline operations and deliver tangible benefits.

This post explores the value of utilizing vendor-provided testing within the frameworks of computer software assurance (CSA), computer systems validation (CSV), and equipment validation. It addresses common pain points and demonstrates how your organization can achieve better outcomes.

The Pain Points of Validation: Why Traditional Approaches Fall Short

Validation processes, whether focused on software systems or equipment, are notoriously resource-intensive. Organizations face significant challenges related to testing and documentation, including:

• Redundancy: Repeating assessments already performed by vendors consumes unnecessary time and resources.
  
  
• Manual processes: Paper-based workflows create inefficiencies, increase the likelihood of errors, and prolong review cycles.
  
  
• Regulatory burden: Meeting FDA and global regulatory requirements requires extensive testing and documentation, which can overwhelm teams without sufficient tools or support.
  
  
• Lack of standardization: Inconsistent practices can lead to compliance gaps and weakened quality assurance.
  
  
• Audit pressure: Preparing for audits requires a comprehensive, transparent trail of validation activities, which is difficult to establish without streamlined processes.

These pain points often lead to higher costs, extended project timelines, and increased risk of noncompliance. Addressing these issues effectively requires a strategic approach that combines both internal and external resources—this is where vendor testing becomes critical.

Vendor testing refers to the testing performed by equipment or software vendors to validate the functionality, performance, and compliance of their products before delivery to customers. Vendors, with their deep understanding of their products, are best equipped to write and conduct thorough testing. By leveraging vendor-provided documents and test results, your organization can eliminate duplication, accelerate validation timelines, and improve accuracy.

The Value of Vendor Testing in Software Validation

Whether you follow the CSV or the CSA approach to software validation, focusing on critical areas that impact patient safety and product quality is essential for an efficient validation program.

Vendor testing offers several advantages, including:

• Efficiency gains: Vendor documents and test results eliminate redundant testing. By relying on pre-existing, trustworthy data, organizations can concentrate on areas that require customization or additional assurance.
   
• Expert input: Vendors conduct comprehensive testing with an in-depth knowledge of their products. Utilizing these tests guarantees a complete and precise comprehension of software functionality. This is particularly evident in the vendor's scripted testing, written with expert insight into how to navigate the tool.
  
  
• Regulatory alignment: Leveraging vendor testing supports compliance with CSA principles by prioritizing critical areas while reducing unnecessary testing efforts.
   
• Audit trail: Vendor documents provide a clear, traceable audit trail, instilling confidence during inspections.

With a robust digital platform like ValGenesis VLMS, you can seamlessly integrate vendor documents into your validation lifecycle. This capability not only reduces manual effort but also ensures that vendor tests are executed electronically, minimizing the risk of errors.

The Role of Vendor Testing in Equipment Validation

For equipment validation, leveraging vendor testing provides unique opportunities to streamline processes while maintaining compliance with Good Manufacturing Practices (GMP). By incorporating proven vendor testing into the validation lifecycle, your organization can save time, reduce costs, and enhance compliance efforts.

With digital tools like ValGenesis VLMS, these benefits expand to include:

• Reduction in redundancy: Vendor testing can be reused for operational qualification (OQ) and performance qualification (PQ) tests, allowing you to replicate vendor assessments with your own materials and processes. This eliminates the need to create new tests from scratch, saving both time and effort.
   
• PDF document reuse and electronic execution: Vendor-provided test documents, often delivered in PDF format, can be reused and executed electronically within ValGenesis VLMS. This capability eliminates the paper burden of traditional validation processes, avoids the need to recreate test documents, and ensures seamless execution.
   
• Cost savings: Leveraging pre-existing vendor-provided test data reduces in-house testing requirements. This minimizes resource allocation and associated costs, freeing your team to focus on other critical tasks.
   
• Enhanced efficiency: Electronic execution of vendor testing accelerates the validation process by avoiding delays caused by manual handling, paper-based documentation, and extended review cycles. Digital workflows make testing faster and more reliable.
   
• Compliance assurance: Vendor test documents ensure that equipment meets FDA and global regulatory standards. Incorporating these documents into your validation strategy strengthens compliance and mitigates the risk of regulatory findings.
   
• Audit transparency: A fully traceable digital record of vendor test documents ensures you are always audit-ready. Detailed audit trails provide confidence during inspections by ensuring full transparency of validation activities.
   
• Data integrity: Storing and executing vendor testing data digitally adheres to ALCOA+ principles. This ensures accurate, secure, and immutable records that meet both quality and compliance standards.

By combining vendor testing with the digital capabilities of ValGenesis VLMS, your organization can significantly enhance equipment validation processes. Reusing vendor PDFs, enabling electronic execution, and centralizing management reduces the paper burden and delivers measurable gains in efficiency, compliance, and cost savings. These advancements allow life sciences companies to confidently focus on delivering high-quality, compliant products to market.

How ValGenesis VLMS Maximizes the Value of Vendor Testing

ValGenesis VLMS provides a robust platform for managing the entire validation lifecycle, including the integration of vendor testing. The Design Manager module enhances this capability by offering specific features that address common pain points:

Features

• Electronic document execution: Executes vendor documents, including PDFs, digitally, eliminating paper-based processes and reducing contamination risks in cleanroom environments.
   
• Centralized repository: Stores all vendor testing documents in a single, secure location, simplifying access and minimizing time spent searching for records.
   
• Automated workflows: Streamlines review and approval cycles, ensuring compliance with quality system expectations and reducing delays.
   
• Customizable templates: Supports the reuse of vendor tests by adapting them to organizational needs while maintaining consistency and accuracy.
   
• Traceability and audit trails: Creates a clear, transparent record of all validation activities, simplifying audit preparation and instilling confidence during inspections.

Benefits

• Faster time to market: Leveraging vendor tests and executing them digitally reduces validation time, enabling quicker project completion and faster scale-up for production, helping you achieve revenue goals.
   
• Reallocation of resources: Minimizing redundancy and extensive in-house testing frees critical resources for higher-value tasks.
   
• Enhanced compliance: A digital, standardized approach aligns with regulatory requirements and reduces the risk of noncompliance.
   
• Improved collaboration: The centralized platform fosters teamwork by ensuring all stakeholders have access to up-to-date information.
   
• Assured data integrity: Electronic execution and secure storage adhere to ALCOA+ principles, maintaining high data quality standards and ensuring digital continuity.

ValGenesis VLMS stands out by enabling systematic digital execution of vendor-supplied PDF test documents directly within the platform, maintaining end-to-end digital continuity. This feature allows you to leverage vendor testing without reverting to paper-based processes that introduce inefficiencies and risks.

Without the ability to execute PDFs directly, organizations using other point solution tools often resort to printing vendor test documents, executing tests on paper, and then scanning them back into the system. This hybrid process is inherently flawed. Scanned documents risk losing critical information, such as screenshots, annotations, and metadata, while introducing data integrity and compliance vulnerabilities.

With ValGenesis VLMS, the process remains entirely digital. Users execute vendor-supplied PDFs directly in the system, eliminating the need for printing and scanning. This approach preserves data integrity, makes every step of the testing process traceable, secure, and compliant, and captures critical test execution elements like screenshots and timestamps seamlessly. Teams gain real-time visibility for audits and reviews, reducing errors and improving operational efficiency.

A Smarter Way Forward

Digitally integrating vendor testing into your validation program is now a reality for organizations seeking to optimize their processes. By reducing redundancy, ensuring compliance, and accelerating timelines, vendor testing provides tangible benefits that directly address the common pain points of traditional validation approaches.

With ValGenesis VLMS and its industry-unique Design Manager module, your organization can unlock the full value of vendor testing, achieving a seamless, efficient, and compliant validation lifecycle. This smarter approach not only enhances validation but also equips your organization to meet the demands of today’s regulatory environment.

Watch this webinar to learn why ValGenesis VLMS is the best technical solution to implement CSA.