Compliance with GxP

GxP, short for “Good Practice,” refers to a set of guidelines and regulations designed to ensure pharmaceutical products are safe, effective, and of high quality. Established by regulatory agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency), these guidelines cover documentation, clinical trial settings, laboratory workflows, etc. Compliance with GxP is mandatory for biopharma companies, particularly in production facilities. The participation of engineers with GxP validation expertise is crucial for ensuring compliance across products, solutions, and systems.

A key aspect of GxP is organizing QA processes from the very beginning of the project. The QA team at Quantori regularly assists big pharma clients in validating solutions, systems, and medical devices, including Laboratory Software (LIMS, ELN, and Integrations).

Systems our team can help validate also include:

• Laboratory Information Systems (LIS)
• Laboratory Robotics and Automation Systems
• Electronic Data Capture (EDC) Systems
• Electronic Batch Record (EBR) Systems
• Medical Device Integration Systems

Requirement Analysis

The Requirement Analysis phase benefits greatly from the expertise of a subject-matter QA team, which brings clarity and accuracy to project documentation. The team participates in both business and requirement analysis, communicating with the customer to identify and resolve errors or ambiguities in drafts, which minimizes revisions later in the development process. Their industry knowledge helps identify issues in business logic, formulas, and units of measurement.

They also conduct risk analysis to prioritize features and areas that need the most attention during testing. They prepare test data and manage complex calculations to ensure thorough test coverage. By reorganizing test suites based on risk, QA can reduce manual regression testing time by up to 50%. This helps speed up delivery while maintaining quality, ensuring the project runs smoothly from the start.

Expert End-User Communication

Having subject matter experts on the development team is crucial for project success, as they can ensure the whole team fully understands customer’s needs. The deep knowledge of a specific life science area helps them transform complex business requirements into actionable tasks. Without their insights, there’s a higher risk of misunderstandings or misaligned features, leading to incomplete or incorrect functionality.

By regularly engaging with end-users — scientists and lab technicians — they ensure the software aligns with real-world workflows, allowing the development team to focus on what matters most to users.

Moreover, the industry expert keeps the team aligned by providing a unified understanding of project goals and ensuring consistency across all phases — from design to development to testing. As a result, the final product aligns with the client’s vision while maintaining high quality.

Data Interpretation

Working with applications that analyze and visualize various data types requires QA engineers to identify issues in how data is displayed. This is particularly critical for chemical structures stored in different formats, where incorrect visualization can be difficult to detect using test automation tools or by engineers unfamiliar with the nuances. Precision is also vital in fields like chromatography and mass spectrometry, where accurate peak detection is necessary. Without it, software errors can lead to costly mistakes for end users.

In these cases, domain-oriented QA professionals can identify issues early, helping to save time and reduce costs.

Knowledge Sharing

A QA team with expertise in life sciences supports knowledge sharing between the contractor and customer sides, improving collaboration across different teams and shortening release time. At Quantori, our QA team manages an internal Life Science Wiki and organizes regular grand rounds and competence meetings. They also create onboarding materials and videos for new team members.

Case Studies Showcasing the Value of QA with Life Science Expertise

1. CAP & CLIA Certification for Internal LIMS

Our Big Pharma customer, a global leader in cancer diagnostics, needed to obtain CAP and CLIA certifications for their Laboratory Information Management System (LIMS). They engaged Quantori to guide them through the preparation and validation process.

Although their LIMS did not handle personal patient data, such as medical histories or contact information, it processed highly individualized genomic data, which classified it as a medical device. Without these certifications, the client’s ability to operate and manage sensitive genomic data would have been compromised.

Quantori guided the customer through the entire preparation and validation process.

They also helped with User Acceptance Testing (UAT) and preparing documentation.

To ensure compliance, the team set up a tool to track requirements and test cases for each part of the system, giving real-time updates on readiness for CAP and CLIA.

As a result, the client not only successfully completed the certification process but also significantly improved their operational capabilities.

2. Creating an Application for Designing PCR Components

Another client needed a robust application to design and quantitatively evaluate PCR and qPCR components. The existing tool was narrow-focused and did not cover all scientific needs, which risked creating a backlog for their customers.

Proper design of key PCR or qPCR components, like primers and probes, is at the heart of any successful PCR. In the past, researchers spent hours or even days trying to identify the best reagents through trial and error in wet labs — an effort that consumed both time and resources. Today, with the help of design tools, users can input a DNA sequence, receive the proper reagents, and order them online.

Building such a tool required a deep understanding of molecular biology. A key factor in its success was the QA team’s strong background in Life Sciences.

The team conducted thorough research in genetics, chemistry, and algorithms, organizing sessions to review scientific articles and identify the most suitable algorithms from various sources. With most members holding PhDs in chemistry and having real lab experience, they completed these challenging tasks.

Throughout all project stages, the research team played a crucial role in testing, from developing criteria to production. Uniquely, actual scientists provided test data, allowing the system to be evaluated using different parameters and helping to verify the results. These insights ensured high accuracy in the PCR components designed for use in real laboratories.

As a result, Quantori successfully created a large-scale, multi-attribute application for designing PCR components — an unprecedented tool in its field. This innovation enabled our customers to sell the components more effectively, ultimately increasing their profits.

Quantori QA Team

The Quantori QA team consists of experts with PhDs in biology, chemistry, and medical science. Many team members have gained hands-on experience in biotech and pharmaceutical laboratories and research centers worldwide.

The team is knowledgeable not only in the technical and scientific aspects but also in the business side of the projects they work on. Many members hold ISTQB certifications, which further strengthen their QA capabilities in testing, automation, validation, and more.

This deep domain knowledge and technical expertise enable the QA Competence team to take a thoughtful, proactive approach to customer requirements and feedback during the entire project delivery process.

Learn more about our QA services here or contact us at contact@quantori.com.