Accuprec manager - Bhushan Amrutkar & Assistant Manager Zankar Shah received training of Compliance and Data Integrity at a workshop held in The Novotel Hotel. Agilent Compliance and Data Integrity Workshop gave insights on laboratory Compliance Data - Integrity, Risks and Insights: From Audit Preparation to regulations.Compliance, deviation management and root cause analysis have become immediate need for the pharmaceutical companies. Data integrity issues in analytical laboratories are driving more regulatory action than ever before. Comprehensive approach in meeting lab compliance is critical for success in tough audits. Trends in audit observations have gone up to meet requirements of Data Integrity, OOS investigations.
Pharmaceutical Industry is a growing and ever evolving industry. The health needs and regulations are the key drivers for this industry. Compliance, deviation management and root cause analysis have become immediate need for the pharmaceutical companies. Data integrity issues in analytical laboratories are driving more regulatory action than ever before. Comprehensive approach in meeting lab compliance is critical for success in tough audits. Trends in audit observations have gone up to meet requirements of Data Integrity, OOS investigations. Agilent understands these needs and this workshop was specifically designed to cover the requirements and the challenges faced by you pertaining to regulations and explores insights from regulatory actions and data integrity.
The training was comprising of how Automated solution will help in reducing data integrity risks and increase productivity • OQ Protocol Configuration – To meet the “Range of Use” • Benefits of Automated Qualification Methodology Vs Traditional Practice • Reporting and Documentation- Paper v/s Electronic • Data Integrity and Security- Benefits of Network distributed Compliance tool The workshop also gave the detail of Root Cause Analysis.