From Detection to Documentation: Your Compliance Ready Analytical Workflow
A 3-part webinar series to help you stay ahead in nitrosamines & NDSRI analysis, from regulatory clarity to method mastery and compliance confidence.
Session 3: From Detection to Documentation: Your Compliance Ready Analytical Workflow
Regulatory compliance doesn’t stop at detection—it extends across your entire data workflow. It requires secure data handling, traceability, and audit-readiness.
This session on software compliance will introduce the latest enhancements in LC/TQ software solutions, designed to meet regulatory standards set by authorities such as USFDA 21 CFR Part 11 and EudraLex Volume 4 Annex 11. Compliance with these regulations requires strict adherence to key principles, including the security of electronic records, proper attribution of work, and the implementation of electronic signatures. The integration of a compliant LC/MS system within a laboratory necessitates technical controls that limit user access to certain software functionalities while ensuring the security of all data, whether raw, metadata, processed results, or reports.
This session will highlight how these systems are designed as closed environments where every user action and instrument operation is tracked and secured, maintaining data integrity throughout the process of acquisition and analysis. The discussion will focus on the technical aspects of compliance, illustrating how Agilent LC/TQ software solutions enable laboratories to meet regulatory expectations while optimizing workflow efficiency.
By participating in this session, attendees will gain a deeper understanding of how advanced software features support compliance efforts, safeguard electronic records, and enhance operational security in analytical laboratories.
Key Takeaways:
- Compliance requirements for electronic records and digital signatures
- Security, traceability, and audit trails in LC/TQ software
- Controlling access, protecting raw and processed data
- Role of closed systems in ensuring data integrity
- Technical considerations for regulatory readiness
- Workflow enhancements through compliant software features
- Expert Q&A to address your compliance and data concerns
Presenter: Dr. Prasanth Joseph (Application Engineer - LC/MS, Agilent Technologies)
Dr. Prasanth is a seasoned professional in analytical instrumentation, specializing in small molecule applications. With 19 years of experience, he joined Agilent in 2015 as an Application Engineer for LC-MS/MS.
He holds a Ph.D. in Environmental Science from Bharathiar University, India, and a master’s degree in business administration from the University of Buckingham, UK. Prasanth has extensive expertise in developing analytical methods for genotoxic impurities, extractables and leachables in pharma and food packaging, and conducting bioavailability and bioequivalence studies. His sk ills also include the analysis of phytochemicals, food residue screening, and contaminants in environmental samples.
