Quality

The Days of Auditing Against Paper Checklists are Gone

News Link: First FDA Audit at AIT Bioscience Using Fully Electronic Records
 

All too often in the CRO industry, the limiting factor in reporting final results isn’t generating the lab data; it’s the lengthy quality review that takes place after testing is complete. The reasons range from cumbersome, paper-driven processes to poor workflows that are reactive rather than proactive. Many of the quality review systems typically built around bioanalytical sample analysis are simply too outdated for today’s technology. Why can’t highly technical bioanalysis be matched with equally sophisticated QA techniques?
 
At AIT Bioscience, QA principles are built into every step of the workflow right at the beginning.
 
Our quality process involves:
 

  • An electronic notebook management system that houses everything from standard operating procedures to final reports in one central place. Documents are held in databases, not filing cabinets, and conveniently accessible through web-style browsers. A feature which has consistently impressed QA auditors. Intelligent forms are created for each bioanalytical method to drive processes, standardize data input, and identify non-conformities in real time. This allows issues to be addressed before they have a chance to occur – not months later on the heels of a deadline.
  • Active participation on the project team. As regulatory requirements, individual sponsor needs, and timeline requirements are defined for each study, communication between the lab and QA is critical to prevent scheduling mishaps that can affect project completion.
  • Thorough vendor audits prior to the purchase of lab software and programs. Solid software-validation packages are fundamental to AIT Bioscience, and QA possesses a practical understanding of the user requirements of the lab to assure that vendor-supplied applications meet those needs reliably, accurately, and securely every time.
  • Data preservation that allows for reliable study reconstruction. Archiving processes that were appropriate in years past are no longer adequate in the high-tech environment of a bioanalytical laboratory. Our QA team ensures that all relevant study data are accounted for and readily retrievable for future consideration.
  • Expert knowledge in current industry trends and regulatory expectations, including risk assessment, vendor assessments, software testing, and validation.
  • Hosting sponsor audits and regulatory inspections AIT Bioscience generates data with the expectation that it can and will be challenged by regulatory authorities. We welcome the opportunity to host your visit with us as well.

For more information about AIT Bioscience’s QA processes, contact us by email or phone at 317-715-8800.