Quality Systems

Our Commitment to Quality Excellence permeates all aspects of our operations. This includes the governance of the techniques and platforms we utilize to perform bioanalytical testing and deliver the reliable results you need to get life-changing therapies to patients faster. 

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Rely on our rigorous quality management systems

All of our laboratories are subject to the stringent and sustainable BioAgilytix Quality Management System (QMS), which is designed according to all applicable regulatory, industry, and internal guidelines for best practices in quality management. The company maintains and follows a Quality Manual which documents the organizational responsibilities, operations, activities, policies, and procedures established for effective execution of the QMS. The BioAgilytix quality organization is quite extensive, reporting directly to the CEO, and staffed with veteran scientists and quality professionals overseeing the execution of the QMS.

The BioAgilytix Quality Management System (QMS) is built upon four key pillars

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Customer Understanding

BioAgilytix works closely with customers to understand the specific needs of their program.  As a result, we offer fit for purpose assays that meet the regulatory requirements that are appropriate for the stage of development of their particular asset.

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Performance and Reliability

BioAgilytix carefully designs custom solutions for each project, providing services that consistently address the needs of customers and other stakeholders. We develop and deliver these solutions with superior quality and reliability, creating high levels of customer satisfaction.

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Regulatory Compliance

BioAgilytix is committed to the highest levels of regulatory compliance and superior performance in everything we do.

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Ownership and Accountability

BioAgilytix takes responsibility for and is transparent about all elements of its Quality Management System.  

Robust implementation and continuous education ensure the effectiveness of our QMS. Each day, we work to establish and monitor measurable quality objectives to deliver reliable results to our customers.   

Data management you can trust

We understand that reported bioanalytical results are key factors that influence decision-making by our clients and can determine whether they proceed with the development of a drug candidate. If the testing data are not properly managed, or are compromised in any way, the development of safe and efficacious drugs may also be at risk.. 

BioAgilytix believes that equally important to the scientific rigor of our laboratories are the technologies and procedures we have in place to manage, organize, secure, process, and back-up our clients’ data sets. We implement and uphold strict data management and reporting systems to guarantee that the data our clients receive is reliable, reproducible, and compliant with regulatory requirements. 

Extremely well-versed in industry reporting standards, we provide the right data in the right format, so you can make the right decisions. Our scientific team works hand-in-hand with our experienced quality assurance department to ensure the most current data-related regulatory compliance. 

BioAgilytix understands that a comprehensive approach to data management is an essential characteristic of the optimal bioanalytical partner. As such, we uphold the following principles of bioanalytical data management:

Data Quality

Our commitment to the integrity and consistency of data outputs is integrally woven into our commitment to scientific excellence in our bioanalytical services. We deliver the highest quality data to our clients as a reliable foundation for scientific decision making.

Data Organization

Understanding that robust data collection and storage methods are critical to delivering quality data, our approach to data organization ensures continuity and consistency throughout every stage of development. We follow established processes and procedures for data collection, and adhere to stringent procedures for digital and physical data storage to ensure your data is always maintained in a secure, compliant manner. 

Data Protection

When it comes to the principles of data management, the security of your data is second to none. Security involves protecting your data from outside threats, as well as ensuring that your data always remains safe and accessible to your project team. We take extensive data management measures to ensure your critical data is always protected, including:

  • Fully-secured facility monitored by our security system with access controls
  • Hourly data backups with daily off-site backups
  • Redundant server configuration and electronic audit trail
  • Uninterruptible power supply backed-up by generators
  • Secure, monitored rooms with limited access
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Quality excellence enabled by Laboratory Information Management Systems (LIMS)

Our laboratories leverage laboratory information management systems (LIMS), such as Watson by Thermo Fisher Scientific, to enhance the efficiency and quality of our clients’ projects. LIMS aid with our meticulous management and vigilance over elements such as process automation, data/storage organization, study protocols, workflows, assay development and validation, sample management, and analytical runs. LIMS enable compliance with regulations including GLP, 21 CFR Part 11, and those from other global regulatory agency guidelines.

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Other innovations for efficiency and quality excellence

In addition to LIMS, BioAgilytix laboratories utilize other technologies, as needed, to ensure efficiency, quality, visibility, and integrity throughout the bioanalytical testing and reporting process. These include:

• Quality Management Systems

• Document Management Systems

• Environmental Monitoring Systems

• Analysis & Statistics Systems

Learn more about BioAgilytix’s quality systems