Today, pharmaceutical companies regulated by the U.S. Food and Drug Administration (FDA) are required to comply with FDA Title 21 CFR Part 11 for their drug development endeavors. This law, commonly known as “Part 11,” regulates electronic records and electronic signatures for life science companies—establishing standards for when these records and signatures can be considered trustworthy, reliable, and equivalent to paper records.
While adhering to 21 CFR Part 11 is an important part of compliance, it does not guarantee data integrity. To help drug development companies overcome their data integrity challenges, Patheon pharma services, a Thermo Fisher Scientific organization, recently hosted a one-hour webinar in which company leaders discussed how they overcame data integrity challenges when evaluating and implementing a new fourier transform infrared (FTIR) spectroscopy and chromatography data system for different areas of their workflow.
Patheon pharma services provides industry-leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers. There are many factors to consider surrounding compliance when evaluating and implementing new equipment such as FTIR spectroscopy and chromatography data systems.
Our on-demand webinar explains how Patheon pharma services overcame data integrity challenges when implementing new FTIR spectroscopy and chromatography data systems.
By watching this on-demand webinar, analytical scientists will discover how to navigate the challenges encountered when meeting data integrity guidelines. They will find out how to choose the right FTIR instrument for data integrity. And they will learn about the evolution of mass spectrometry as a pharmaceutical quality control tool while better understanding the importance of selecting the right chromatography data system (CDS) to ensure data integrity and compliance for mass spectroscopy.
Our on-demand webinar, Patheon Experience: Overcoming Challenges to Ensure Data Integrity and Standardization” guides you in your selection of the right FTIR spectroscopy and chromatography data systems that help you meet 21 CFR Part 11 data integrity standards.
Jennifer Christianson is Market Development Manager at Thermo Fisher Scientific.